Medtronic plc (MDT) Earnings Call Transcript & Summary

Hello, everyone. I'm Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations. Welcome to the Medtronic 2020 Investor Day. Before we officially kick things off, I'd like to provide you with a few details for today's event. First, we will be making several forward-looking statements and referring to non-GAAP financial measures. And actual results might differ materially from those projected in any forward-looking statement, given risks and uncertainties, including those related to the impact COVID-19 has had and is expected to continue to have on our business. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports and other filings that we make with the SEC. And we do not undertake to update any forward-looking statement. In addition, we will be showcasing a number of products that don't have regulatory approval yet, and I encourage you to read these disclaimers. You also will hear from some physicians that are paid consultants of Medtronic. I encourage you to go back and read these statements and disclaimers on our website, investorrelations.medtronic.com. Also on our IR website, we'll post links to all GAAP to non-GAAP reconciliations. And shortly after the conclusion of our event, you'll be able to find the content and graphics from today's presentations and video replays of today's segments. Next, in order to help you plan your calendars, I thought it would be helpful to share our tentative earnings release dates for the remainder of fiscal '21. We, of course, will confirm the dates closer to each event through our earnings announcement press releases. Our second quarter earnings call is coming up next month, on November 24, the Tuesday prior to Thanksgiving. I also want to note that we intend to continue our popular General Manager Call Series, and we'll let you know what's next as those dates are set. For those of you following today's event on social media, I encourage you to post using the #2020MDTInvestorDay. Today, we have a full agenda prepared for you. Today is all about how we intend to accelerate growth. Up next, our CEO, Geoff Martha, will give his opening remarks. Then we'll get into a segment that speaks to how we are going on the offensive and taking share. In this section, you're going to hear from 8 of our businesses on how our pipeline is accelerating growth. After this, we'll have a Q&A session with Mike Coyle, Bob White, Brett Wall and Sean Salmon. And then we'll take a 15-minute break. After the break, we'll resume with the segment on how we are creating and disrupting big markets. In this section, you'll hear from 7 different businesses, where Medtronic is in the process of creating new markets or disrupting existing ones. After this, we'll have our second Q&A session with Dr. Laura Mauri, our Chief Clinical and Regulatory Officer, who will be joined by Mike Coyle and Bob White. Then we'll take another 15-minute break. And after the break, our CFO, Karen Parkhill, will give a financial presentation. Following that, Geoff and Karen will take analyst questions, and then Geoff will provide some concluding remarks. And a note on the breaks. While we understand that you may need to step away, we will stream videos during the breaks to showcase our focus on ethics, our philanthropy efforts and supplier diversity initiatives. You'll also get an inside look to our supply chain and hear from patients around the world who have received our products and therapies. So if you can stay, there's a lot to see, and I think you'll find it interesting. Finally, I would like to take a moment to recognize the Medtronic Investor Relations team, the great team that I get to work with every day. And I'll humbly offer one of the world's top IR teams. Many of you may have heard that our IR team was recently recognized for the best investor event by IR Magazine for the Robot Investor Day we held in Hartford, Connecticut last fall. So the bar has been set high for this team, and I'm hoping we exceed your expectations with today's event. To introduce the team, many of you know and work closely with Francesca DeMartino, who joined my team a little over a year ago. Francesca played a significant role in creating what you're going to see and experience today. And many of you also interact with Wynne Edgson. Wynne's currently on maternity leave, so Marc Welk joined us on a temporary basis. Marc is about 2 months into the job, but you wouldn't know it, given his high level of contribution. Today also wouldn't have been possible without the contributions of the rest of the IR team, including our associates, Phillip Brehl, Charles Ellson and Justin Emry; our veteran meeting planner, Tracy McCartney; and our administrative assistant, Robin Putnam. Thanks, team. I also want to thank the numerous people across Medtronic who help pull together today's content. I want to especially recognize Mike Caputa from our corporate marketing department. When we pivoted to a virtual event, Mike stepped up in a big way and became a de facto member of the IR team to help produce today's video content. So with that, if everyone's ready to go, let's get started. [Presentation]

Good morning, good afternoon and good evening to all of you joining us from around the world. It's my pleasure to welcome you to the 2020 Medtronic Institutional Investor and Analyst Day. We're excited to talk to you about our growth strategy and the breadth of innovation occurring across our businesses, as well as our plans to create significant value for our shareholders in the near and the long term. But before we get into today's content, I just want to thank everybody for your support over the last year as I've moved into this new role. I really appreciate the feedback from you, our investors, as well as the input from our employees and our customers. Today, you're going to hear from a number of our business leaders and get a closer look at our pipeline. While I'll let them take you through the deep dive into the pipeline, I'm going to use some of my time to cover 2 additional topics of particular relevance today. The first is the organizational and cultural changes we're making at Medtronic to accelerate growth and drive even greater innovation today and into the future. The second is Medtronic's role in society and our ability to influence the issues of the day. We hope that you'll find the information today helpful and come away understanding how we will create value in the next chapter of Medtronic's journey. Importantly, our #1, our #1 priority going forward is accelerating growth. Today, you're going to hear about our plans to drive revenue growth, both in the near term and over the coming years. And thanks to a robust product pipeline supported by multiple technology platforms, we have a strong confidence in our ability to sustain a higher level of growth over the long term. You're going to hear about how we're finding a new gear. And we're making a number of changes across the business to make Medtronic more agile, decisive and competitive. These are changes to our org structure as well as to our culture that will enable us to go on the offensive and take share. I'm also excited to share some of the ways that we're creating and disrupting big markets, both with our own pipeline and with the allocation of capital to large and promising growth opportunities. Now this includes exciting in-house innovation as well as tuck-in acquisitions and creative partnerships that will further leverage up our R&D. All of this will help accelerate growth. Finally, you're going to hear about our financial objectives. With accelerating top line growth, significant free cash flow generation and smart capital allocation, Medtronic is positioned to drive double-digit shareholder return. Let's first talk about where Medtronic is today. As you know, Medtronic has been very successful in creating new markets and medical technology. Over the decades, we have demonstrated an incredible ability to identify unmet needs and work with physicians to invent technology. We do the clinical trials. We get the regulatory and reimbursement approvals all over the globe. We train the physicians. And ultimately, we progress a technology to a standard of care. Now this is not easy, and not everyone can do this. But we have the expertise to repeat this over and over again. I'm proud to say that today, we have the strongest pipeline in our company's history. This includes innovation we're launching now and products that are expected to disrupt markets in the next few years. Wave 1 is here. With new products like our Micra AV pacemaker, Intellis with DTM spinal cord stimulator, Percept DBS, InterStim Micro, Touch Surgery enterprise and our MiniMed 780G system, just to name a few of the 130 product approvals that we've had since January. And as we look ahead, the next wave of innovation is even more exciting with EV-ICD, renal denervation, pulse field oblation, PillCam Genius, our Zeus and Synergy sensors as well as our soft tissue robotics system. One of our core differentiators is our ability to take cutting-edge technology and apply it to medical technology. This is what I'd like to call putting the tech into medtech, and it's key to disrupting our markets. We're uniquely transferring advances from the tech space like wafer-scale manufacturing to the medical device space. This is a game-changer for products like LINQ II and our forthcoming Synergy CGM sensor. Wafer scale drives not only new capabilities but efficiencies and cost reductions. And with the emergence of big data sets, combined with innovation in robotics, sensor technology, computational power and AI, some of the greatest advances in medical technology are unfolding right now at Medtronic. With an advantaged footprint in key markets around the world, we're able to help even more patients globally. Over the last 9 years under Omar's leadership, Medtronic grew our emerging markets portfolio by double digits annually into what is now a $4.7 billion business. We're ahead of the curve here. No other medtech company has the same level of infrastructure and capabilities in these markets. And we expect to take advantage of our differentiated position to drive significant emerging market growth going forward. In a couple of weeks, it will be 1 year since I became president of the company and about 6 months since I became CEO. Over the last year, the Executive Committee and I have been focused on how we can build on Medtronic's strong foundation to make us a better company. We looked at where we could enhance our strategies and strengthen our capabilities. We asked ourselves how we can get better organized and improve our execution. But the fact is that too often, we've been growing below our markets. And our market share is not commensurate with our technology leadership. And while there are things that we do really well, there are some areas that we can improve. And we came away from this process united behind the need to make transformative, structural and cultural changes. For example, we needed to address the amount of our revenue that was coming in the final month and weeks of the quarter. This made our results seem more volatile than they really were. And we work to significantly decrease bulk orders at the end of the quarter, and we were able to minimize the impact on our financial results. In many cases, we actually gained share in the process. And going forward, we're in a much better position. It enables us to be more of a run rate business and allows us to see trends better and react more quickly. Next, regarding capital allocation, we've added new portfolio management processes to make sure our highest-growth opportunities receive the investment needed. We've also increased our cadence of tuck-in M&A. Since January, we've announced 6 deals totaling over $1.6 billion, and we expect to do more. We're also leveraging our R&D through innovative partnerships, like the one with Blackstone in June. We also need to bring a renewed focus on competitiveness and speed. Medtronic employees believe in our mission and are hooked on innovation. And look, these are great traits. However, too often, Medtronic would develop new markets only to seed share too easily when competitors would enter. We need to increase our competitiveness. Gaining market share creates the fuel, the fuel that we need to invest in new therapies and create these new high-growth markets to lead the medtech industry forward. And to drive greater speed, we needed to reorganize ourselves. Our matrix organization was too bureaucratic. Decision-making was spread across too many people and up and down too many layers, slowing us down dramatically. This is changing. We've introduced a new operating model that in this operating model, we'll be implementing across the company over the next several quarters. These changes will simplify the organization, accelerate decision-making and execution and more effectively leverage the scale of the enterprise. Now the concept around our new structure is going from 1, $30 billion company to 20, $1.5 billion agile companies that give our end businesses greater focus, more empowerment and accountability. The operating units are the heart of this new structure. There are 20 of them, focused on their end markets around either a narrow disease state or around a specialty physician type. We empower these operating units by giving them control over their P&L and their go-to-market strategy, which they did not have before. We empower them by giving them decision rights, which were previously spread across our old matrix. In the old model, for example, structural heart reported up to the Coronary & Structural Heart division, which then reported up to the Cardiac and Vascular Group, which then reported up to the CEO. In the new model, we've replaced the groups with portfolios and significantly streamline the old group infrastructure. And we unnested the operating units with less layering between them and the executive management and me. The operating unit leaders will report to our portfolio leaders who will be focused on driving strategy, allocating resources and assessing performance as well as growing our WAMGR. All of this rather than being day-to-day operators. Our operating unit leaders are now closer to the customer and will decide how they want to allocate their investments to drive the highest returns in their markets. In addition, they're in control of their own R&D resources and their sales forces for all of the developed markets plus China, and this amounts to approximately 90% of Medtronic's revenue. But at the same time, we're holding our operating unit leaders accountable and rewarding growth. We're still measuring these leaders on operating profit and free cash flow, but we're reworking our employee incentive plans to be more heavily weighted towards revenue growth and market share. We will incorporate these metrics into our performance objectives for this fiscal year and plan to build them into our incentive plans for next fiscal year. This new operating model has been tested in the Restorative Therapies Group, which I previously led. With RTG, we accelerated our organic revenue growth to 6% in my last full fiscal year, and we did this while also improving our profitability. This new framework allows us to apply what we learned in RTG and combine those learnings with the insights of either group, region and functional leaders. And this will help us develop a model that allows us to play small and be focused, to be more customer-focused, to deliver faster innovation and to take share and to win. But at the same time, this new model will allow us to play big, using our scale to improve efficiency by consolidating operations at the enterprise level around specific areas. We are taking our core advanced technologies, for example, and applying them to multiple businesses to accelerate product development. Battery technology is 1 example. Robotics is another. We're consolidating manufacturing to realize economies of scale and improve upon our already high-quality standards. And we're providing a single point of contact for large customers like governments or large health care systems as well as GPOs, so they can deal with 1 Medtronic where, when they want to. These actions will free up business leaders to focus on their customers while allowing the enterprise to realize synergies and leverage its cost structure to create significant value. It's still early. But we're very encouraged by the feedback we're getting from our employees all across the company. And an employee morale, which we measure a lot, is at all-time highs. Now turning to capital deployment. Investment in our businesses and pipeline is our top priority. We'll use our own P&L to fund organic investment in R&D as well as sales and marketing. This includes using our strong balance sheet to make minority investments and tuck-in acquisitions or through innovative partnerships. This will enable us to effectively leverage our R&D spend. Higher R&D spend, both internal and external, and a stronger portfolio will translate into higher medium- to longer-term growth, all while still delivering on our near-term commitments. Karen will talk more about how we're allocating capital, generating free cash flow and funding innovation later today. I now want to spend a few minutes talking about the role Medtronic can play in society. Anyone that knows me understands that this is personal to me. And it's part of our company's DNA. Our ESG efforts are grounded in our mission, which has been part of our culture for 60 years. Tenet 1 of our mission speaks to increasing the availability of our products and services to all people around the globe. Tenet 2 is about innovation and creating new markets. Tenet 3 focuses on our product quality and being recognized as a company of dedication, honesty, integrity and service. All tenets of our mission are closely aligned with the specific UN Sustainability Development Goals. Our mission also calls us to recognize the personal worth of all employees. And this drives our inclusion and diversity efforts. We're focusing on advancing the fair treatment and representation of all ethnicities and genders. And we're doing this by ensuring our employees have equitable opportunities and pay. Years ago, we established 5 diversity networks at Medtronic, which develop and advance the careers of our diverse employees. These networks also increase inclusion and a feeling of belonging, which established Medtronic as an employer of choice for diverse talent. We're committed to ethnic and gender diversity in our management as well. Five years ago, we set goals of achieving 20% or more ethnically diverse talent in management roles in the U.S. and 40% or more women in management roles globally. We've exceeded our goals on ethnic diversity. And with women, we're just 1% shy of our goal. But we're not done here. This is a key priority for me, the Executive Committee, and it's an objective of our leadership across the company. We also want to make sure that we're doing our part to sustain our planet. We're announcing this week that we intend to be carbon-neutral in our operations by the end of the decade. Today more than ever, people want to be associated with companies that are inclusive, forward-looking and make the world a better place. Studies show that -- the decline in trust for institutions and for governments, and people are looking to organizations like ours to lead the way. We're able to attract top talent to work for us. Leading companies want to partner with us, and our customers want to do business with us, not only because of our leading technology and the quality of our products, but because they want to be associated with a company that has a sense of mission and purpose. Okay, I get it. It's hard to put this advantage into your models. There's no line on the balance sheet that reads ESG. But I'm telling you, as we move forward, our mission and focus on ESG is one of the most powerful assets we have and one that is only getting stronger. So let me wrap up where we started. We have an unwavering focus on accelerating growth at Medtronic. We've been talking to you about our pipeline for the last 12 to 18 months. That pipeline is now coming to fruition. I knew when I took over, we had a great pipeline. And that alone would drive acceleration in our growth. But I also wanted us to become a more nimble organization. One that isn't handicapped or held back by bureaucracy, one that is capable of playing both big and small at the same time. I also wanted to upgrade our culture, adding in aggressiveness of, "I hate to lose mentality," that sits on top of our mission. And finally, we needed to address underperforming businesses. So we made a number of changes. And this started more than 12 months ago. You're aware of diabetes, but it wasn't just diabetes. All of this, all of this was done to position us to capitalize on this pipeline, not just in the near term but in the medium and the long term, particularly as some of these disruptive technologies make their way to the market. We're focused on leveraging the enterprise and driving strong EPS growth. And we're converting those earnings to free cash flow. In the end, we're committed to delivering double-digit total shareholder return driven by solid EPS growth, combined with our growing dividend. Medtronic is on the offensive. We're accelerating growth, and I could not be more enthusiastic about where we're headed. So now let's turn to our first theme of the day. We're going to highlight a number of our businesses that are using innovation to go on the offensive and take share. [Presentation]

When we talk about going on the offensive and taking share, there's really no better place to start than with our Cardiac Rhythm business. This is one of our largest businesses, and it's in a mature market. But we're disrupting it. We've got great momentum with several product launches and true innovation. Growth is poised to accelerate here. So to share more, here's our President of CRM, Mike Marinaro.

Thank you, Geoff. I'm excited to talk to you today about the strong momentum in our cardiac rhythm management division, one of the largest divisions at Medtronic with $5.1 billion in revenue for fiscal year '20. Looking forward, we see a tremendous opportunity to accelerate our growth and share. The global market for implantable therapy and diagnostics devices is now more than $9 billion and growing modestly every year. We are proud to be the leader in each of the product categories where we compete. Over the last 2 years, in both the low-power and high-power segments in the United States, we have gained 2 to 3 points of unit share in initial implants. As evidenced by our results in the first quarter, we have continued on the offensive, accelerating our share growth. While the revenue acceleration from our initial market share has been masked by headwinds from lower replacement device volume over the last several years, we are now emerging out of this cycle. We have started to see replacement device volume return and are forecasting this as a tailwind for our business over the next 3 years. In May, we launched a new campaign to reach every patient everywhere to aggressively promote our unmatched leadership in digital health. Combined with the launches of Micra AV, Cobalt and Crome and LINQ II, we are confident that we will continue to accelerate growth and capture share. Now we would like to tell you more about why we are driving market share gain. In 2002, Medtronic's Cardiac Rhythm business introduced the world's first remote cardiac monitoring system. Since then, we've revolutionized this market with new digital and remote patient management capabilities that we have scaled globally. During this pandemic, telehealth and remote patient management have never been more important. Medtronic has invested in several exclusive technologies that are proven to be especially beneficial today. They include our app-based monitoring. Patients can now use their own smartphones to monitor their implanted devices on our proprietary apps. Only Medtronic can offer this capability across our entire device portfolio. Our published data shows that patients' compliance on remote monitoring approves about 20% when they use their own smartphones with our app as compared to traditional bedside monitors. Medtronic is the only company with the ability to program devices from a distance. We are now supporting cases from a safe distance, such as nearby control rooms inside the hospital or even from locations that are entirely outside of the hospital. In this FaceTime video, you will see a Medtronic representative supporting an implant remotely via a tablet. Remote programming technology reduces the potential exposure to COVID or other diseases, keeps patients safely at home and reduces the use of personal protective equipment. We will continue to strategically invest to maintain our leadership in key therapy areas and to extend our competitive advantage in telehealth and remote patient management to drive improved outcomes, efficiency and experience. I talked earlier about our market share gains in traditional market segments. Now that you've heard about our clear leadership in digital solutions, let's talk about the innovative devices that connect to this ecosystem. Here is Dr. Kweli Thompson, the General Manager of the High Power business, to highlight the advantage of the Cobalt and Crome ICD and CRT-D portfolio.

Thanks, Mike. We're in the early stages of launching Cobalt and Crome. These devices are turning into a huge success for us in the market. We're on the offensive in capturing market share for 3 reasons. First, we've collaborated with our health care providers to generate clinical and economic evidence focused on outcomes that matter. Patients who receive our devices have been shown to have an improved response to cardiac resynchronization therapy, experience a reduced risk in atrial fibrillation and live longer when compared to patients who do not receive our therapies. Our customers highly value these features. Recently in Japan, our clinical evidence paved the way for incremental reimbursement for 1 of our exclusive features. Second, we've improved battery longevity by 25% and enhanced our heart failure diagnostic capabilities to neutralize any perceived competitive feature advantages. Third, we've introduced Bluetooth connectivity, which enables distance programming, a feature exclusive to Medtronic. As you can see in this chart, our Cobalt and Crome devices have several features that provide multiple layers of differentiation versus our competition. We're confident that we will continue to win market share with our exclusive features in both our legacy devices as well as our new Cobalt and Crome platform. Back to you, Mike.

Thanks, Kweli. Now that you've heard how we will win in our high power business with the Cobalt and Crome portfolio, I'm pleased to have Julie Brewer, the President of the Cardiovascular Diagnostics and Services Business, here today to share with you how we are extending our leadership in this space with the launch of our next-generation technology, LINQ II.

Thanks, Mike. As you heard earlier, Medtronic is leading the way with wafer-scale technology, applying this innovative manufacturing capability that is used in the tech sector to medical devices. This allows for a new level of precision and will be a platform to maximize longevity, sensor capabilities and manufacturing efficiency. We have invested for over a decade in this unique infrastructure. This approach will be very difficult for others to replicate. In addition, it offers exciting capabilities beyond what you could achieve with the traditional titanium can. LINQ II is our first technology to leverage the wafer scale platform. The launch of LINQ II now offers 50% greater longevity than either the Boston Scientific or Abbott devices, market-leading accuracy and exclusive new detection capabilities that help identify patients who are at high risk. And with our unique remote capabilities, we are reducing the need for patients to return to the clinic or hospital for reprogramming, keeping them safer at home. LINQ II is also a revolutionary platform designed for future innovation such as expansion into new chronic disease states. In addition to continued penetration and leadership in the stroke population, where we enjoy 90%-plus share, we are also expanding to heart failure. Earlier this year, we began our ALLEVIATE heart failure clinical study to evaluate the extension of remote monitoring to help manage the millions of patients in the U.S. who have heart failure. We created the ICM space and are building on 20 years of experience with our fifth-generation technology. This exclusive platform enables continuous innovation, further widening the gap with our competitors' first-generation devices. This is an exciting market, and we are poised for further leadership and growth. Back to you, Mike.

Thank you, Julie. As you've seen in these highlights, we're going beyond traditional medical technology and taking on new territory. We're upending manufacturing with wafer scale innovations. We're making our core technologies even better with new and proven benefits for patients, doctors and health systems. And we're safely and remotely connecting patients with their clinicians for the entire life cycle of their devices in a way that only medtronic can do. We're thinking, acting and delivering like a technology company, accelerating product development and serving patients to drive our position further in the market. Now back to you, Geoff.

Thanks, Mike. Hey, look, it's great to see the momentum in this business, and the opportunity in front of us to really disrupt the competition and win share is exciting. We've got bold plans for our diagnostics and our LINQ platform, not just in the cardiology space either but more broadly. And later today, we'll share more about our CRM pipeline when we talk about our micro pacemaker and extravascular ICD, which together give us a really strong runway in CRM. Now let's turn to TAVR, which is one of our biggest growth drivers. Our TAVR business found new momentum with strong data coming out of ACC earlier this year. You saw it in our last quarter results, and we're making the investments necessary to sustain it. Here to tell you more is the President of our Structural Heart business, Nina Goodheart.

Thanks, Geoff. We view the global TAVR market as an ongoing significant growth opportunity for us, and we are committed to achieving global market leadership. The TAVR market is expected to grow in the low teens, reaching over $7 billion by fiscal year '25. We are well positioned to capitalize on this growth with Evolut's strong clinical data and the future platforms we have under development. Medtronic remains the market leader in Europe and has maintained this leadership position over multiple years due to strong clinical acceptance of Evolut's industry-leading hemodynamics, successfully defending our share against competitors that are now trying to enter the U.S. In the U.S., we've gained 1 point of market share sequentially last quarter due to strong clinical evidence that we released at ACC in March, which we believe was a turning point for adoption of the Evolut platform. Field hiring and training remains on track, and we continue to add new accounts. Evolut is now the only valve indicated for bicuspid intermediate risk and above in Europe. And we have received FDA approval for modification to the low-risk bicuspid aortic stenosis precaution. We continue to see strong global adoption of our latest generation Evolut PRO+ system. This system builds on our industry-leading hemodynamic performance while making further improvements to help potentially reduce PVL across all valve sizes, including the 34-millimeter valve. It also has the lowest delivery profile of any system on the market, which is important for minimizing vascular complications. With low risk approval, we are treating patients who are younger, more active and more often have bicuspid valves. These factors are driving a paradigm shift in device selection criteria. We know that physicians continue to look for excellent procedural outcomes in these challenging anatomies as well as durable valve performance in younger patients. Hemodynamics are the key determinant of durable valve performance. This is a priority in device selection to help reduce the risk of reintervention due to early valve failure in the future. The self-expanding, super-annular design of Evolut meets these needs by providing excellent procedural outcomes in industry-leading hemodynamics. For these reasons, we are confident that Evolut will be the valve of choice and will continue to drive Medtronic to global TAVR leadership. I've asked Dr. Jeff Popma, our new Chief Medical Officer for our Coronary Renal Denervation and Structural Heart businesses, to share more about our clinical competitive advantages. Jeff?

Thanks, Nina. Through a decade-long cadence of well-designed clinical trials, the super-annular Evolut transcatheter valve has achieved excellent procedural outcomes, establishing a clear competitive advantage. In comparison to surgery and other transcatheter valves, Evolut delivered industry-leading hemodynamics performance, resulting in long-term valve durability, which may be particularly important in younger patients. Due to its super-annular design, Evolut is the only transcatheter valve to show larger aortic valve areas and lower gradients in surgery up to 8 years after the procedure. Similarly, low gradients were sustained out to 8 years in the Italian registry. By comparison, hemodynamics for the balloon expandable SAPIEN valve from Edwards showed no reduction in mean gradients relative to surgery 5 years after treatment. Evolut has also shown low rates of clinically significant valve thrombosis, a potential precursor for structural valve deterioration. Conversely, in the PARTNER 3 study presented at the ACC 2020, there was an increase in valve thrombosis from 1% at 1 year to 2.6% at 2 years in Edwards SAPIEN 3 valve, which is higher than in patients treated with surgery and higher than those observed in the Medtronic Evolut low-risk randomized trial. In case you missed this presentation at EuroPCR in June, in the vivid registry of patients with surgical valve failure, Evolut showed significantly less valve reintervention compared to SAPIEN at 8 years. Importantly, use of the SAPIEN valve was an independent predictor for late reintervention. As published in JAMA Cardiology, Medtronic is the first company to report TAVR outcomes in patients with bicuspid aortic valve disease at low surgical risk. TAVR using the Evolut PRO platform demonstrated excellent procedural success in bicuspid patients as evidenced by low gradients, no cases of moderate PVL and no cases of any rupture. The need for a permanent pacemaker has continued to fall in clinical practice with the Medtronic Evolut PRO+ platform now 10% in real-world patients in the TBT registry. Data from centers using the [ custom ] overlap implantation technique looks promising for reducing pacemaker rates, and we're studying this further in the optimized PRO trial. We believe that industry-leading hemodynamics of Evolut will ultimately demonstrate its greater durability compared to SAVR and any other currently available valve platforms. Back to you, Nina.

Thanks, Jeff. You've quickly become a valuable addition to the Medtronic team since joining in June. We're so convinced of the hemodynamic benefits of our platform versus Edwards that we're going on the offensive and studying it head-to-head. We're pleased to announce today the initiation of the SMART trial, a head-to-head randomized comparison of Medtronic Evolut PRO and PRO+ and Edwards' SAPIEN 3 and Ultra in 700 patients with a small native annulus and in those undergoing TAVR for surgical valve failure. These groups represent approximately 40% of TAVR patients. The SMART trial will compare 1 year co-primary endpoints that will include clinical noninferiority, all-cause mortality, disabling stroke and repeat rehospitalization and hemodynamic superiority. We believe Medtronic Evolut will prove to be the valve of choice in this patient population. We are excited to demonstrate its performance through this head-to-head trial. As global leaders in structural heart, we're also investing in expanding access to TAVR for all aortic stenosis patients. To that end, Medtronic has initiated a new clinical program, the Evolut EXPAND TAVR I Feasibility Study, to evaluate our self-expanding, supra-annular valve in new patient populations outside of current guidelines for aortic valve replacement. We are focused on understanding the use of TAVR prior to signs of deterioration in LV systolic function. We assess the clinical and hemodynamic performance of Evolut in these patients to inform future clinical work. We believe that Evolut is uniquely positioned to benefit the significant patient population. This represents the next frontier in bringing TAVR to standard of care for all aortic stenosis patients. As we look to the future, we're continuing to invest in innovation and have an exciting pipeline of products to meet key customer needs. The innovative Evolut FX system aims to bring improvements to the overall procedural experience through enhancement in deliverability, implant visibility and deployment stability. This will be followed by a next-gen system designed to simplify post-TAVR coronary access and valve alignment to the native anatomy. We're also focused on broader, more transformative innovations that will allow us to build toward a future state when patients will receive multiple valves over their lifetime. We believe that Evolut is well positioned as the valve of choice for all aortic stenosis patients. This is demonstrated by the excellent data presented at ACC, constant cadence of excellent procedural outcomes and superior hemodynamics. We are excited to advance our pipeline of innovation and initiate these new clinical trials to demonstrate the unique value proposition of self-expanding, supra-annular TAVR in increased patient populations. Ultimately, we believe Evolut is the best valve of choice for the majority of patients, and this will translate into share gains in this fast-growing market. Back to you, Geoff.

Thanks, Nina. When I talk about being more competitive, TAVR is a great example of that. And I hope you saw how Nina is taking this business forward to lead in the sustainable growth market and go after the U.S. share opportunity that's right in front of us. We're aggressively investing in TAVR. And we're going to back up our differentiated technology with clinical evidence by running the SMART head-to-head trial against Edwards. Now we're going to come back to Nina's business a little later today when we talk about the new market opportunities in transcatheter mitral and tricuspid. But now let's move over to Surgical Innovations, one of our largest businesses and a strong business that grows at a mid-single-digit clip. I've asked our President of SI, Matt Perry, to share with you how we're going on the offensive by using innovation to target parts of the market where we have low share. So Matt, tell them how we're going to win here.

Thanks, Geoff, and appreciate the introduction. First and foremost, the investment community knows the Medtronic surgical business, with its roots tracing back to U.S. Surgical. You also know our reputation as the leader in surgical devices that delivers consistent quarterly growth in the mid-single digits. I'm here today to tell you why the Medtronic surgical team is excited for what's ahead of us. We know new product innovations will elevate this business and elevate Medtronic. Let's take a look at our leadership. We lead with our belief that medical technology should improve outcomes and lower costs. We know it's possible because we've been doing it for 60 years. This legacy of leadership uniquely positions us for continued success and revenue growth in one of the most attractive markets in health care today. Our $5.4 billion surgical business is outpacing competitors, driven by differentiated technologies that are preferred by OR teams across the globe. The Medtronic surgical business is positioned for a strong future and ready to capitalize on it, and we're well prepared to take market share. During the past 2 years, we faced specific supply challenges, including complex SAP implementation, capacity constraints and sterilization issues. With a sustained focus on strengthening our entire supply chain, these challenges are behind us. It's time to accelerate our growth and take share. While we have many drivers, today, I'll highlight 3 that I think are the most compelling. First, let's talk about our largest market, which is surgical stapling. We're the leader in the $3-plus billion endostapling market segment. This is largely due to the clinical acceptance of our Tri-Staple technology. We'll continue to deliver meaningful innovation here and strengthen our leadership position in minimally invasive surgery by introducing products like the small diameter reload, the only true 8-millimeter reload on the market. Our small diameter reload allows access in tight spaces and aids and dissection around delicate tissue structures. It's compatible with all of our surgical staplers, including Signia, the world's first smart stapler. Developing specialty specific products that fill an unmet need for surgeons is what made us the market leader and keeps us in that position. Our ambition goes beyond leadership in endostapling. At Medtronic, we want to be the leader in every segment of the stapling market, including both open and circular stapling. At over $1 billion combined, the open and circular stapling segments represent roughly 35% to 40% of all surgical procedures where staplers are used around the globe. These are attractive markets where we don't have a leadership position but we should. Our share today in open circular stapling is only about 40%, which means there's over $500 million of opportunity for us to go after, and it's largely in the hands of 1 competitor, J&J. We've revamped our portfolio, and we're launching the same Tri-Staple technology in open and circular stapling as we have in endostapling. This means surgeons can now use Tri-Staple technology regardless of the surgical approach, open or MIS. These new products offer excellent growth opportunities, and we're excited about our chances to lead across all 3 segments in our largest category, surgical stapling. The second area of our growth is our next largest business, which is Advanced Energy, another $3-plus billion market segment where our leadership is currently built upon our strength of our LigaSure technology. We'll continue to add to our LigaSure portfolio with new devices for the RF energy segment. For instance, the LigaSure Maryland jaw thoracic device is the first and only minimally invasive hand instrument specifically indicated for sealing pulmonary veins and arteries. Thoracic surgeons are telling us they appreciate the procedural efficiency they get from this product. We lead in the RF segment, which accounts for about 60% of the Advanced Energy market. But we're most excited about our opportunity in the remaining 40% of the market, the ultrasonic segment, where our share today is only in the single digits. The vast majority of share of this segment sits again with only 1 competitor, J&J. We intend to realize this opportunity by leveraging the technical innovations we have implemented into our second-generation Sonicision device. It's an exciting addition to our Advanced Energy portfolio for procedures where speed of dissection is critical, and it will allow us to more meaningfully compete and take share in ultrasonic. The ultrasonic segment is over $1 billion, and our upside here is huge. We are confident that with continued innovations such as these products, we can maintain our market leadership and accelerate our growth in the Advanced Energy segment. The third and final area I'd like to highlight is visualization. While we're sustaining and growing our core businesses, we're also expanding our footprint into high-growth segments and geographies where we can make a meaningful impact for patients and our business, both in the short and long term. Our entrance into the fast-growing $2 billion visualization space with the EleVision portfolio is a prime example. We've launched marquee products for our new visualization business outside the United States, including the EleVision HD2, which provides an optimized, customizable, minimally invasive surgery solution. The HD2 is also compatible with TipVision, the world's first surgical videoscope with dual chip-on-tip technology. TipVision provides a fog-free and focus-free surgical experience for clear, consistent visualization. With our differentiated technology and strong synergies across our broader surgical offerings, we're confident about our ability to gain share now and into the future. In conclusion, we're in big, healthy markets with strong leadership positions and opportunities to accelerate growth. We have a stream of meaningful innovation in our core market-leading portfolios like stapling and Advanced Energy. We're extending our technology into segments like open and circular stapling and ultrasonic energy, where we have significant upside and opportunity to gain share. We're making strategic moves into new high-growth segments like visualization. Our business is strong, and our strategy is sound, and I'm confident that Surgical Innovations is poised to deliver above-market results for Medtronic. Thanks for the opportunity to share the Surgical Innovations story with you today. And now I'd like to hand today's event back to Geoff. Geoff, take it away.

Thank you, Matt. Our Surgical Innovations business is one of the jewels of Medtronic, but we can absolutely accelerate growth there and chip away at the competition. And in case you missed it, there's about $1.5 billion that's up for grabs between open and circular stapling and ultrasonic. And we're going to use our innovation to win share in these areas. And as for the $2 billion high-growth visualization segment, this is another great opportunity for us to accelerate growth in SI. Next, let's move on to Diabetes. This is a high-growth market, but we've been missing out of late. We knew that we needed to make some major changes here, and that's why one of my first moves when I was named president last August was to put Sean Salmon in charge of this business. So let me turn it over to Sean and let him tell you how we're going to turn this business around.

Thanks, Geoff. We've taken a number of bold steps to get this business back on track. This transformation started 12 months ago when I was named to lead Diabetes. It was evident that we needed to close some product gaps, most importantly in CGM. It was also evident that we needed to drive better overall execution. And since taking on the role, we've taken several actions. First, I brought in a new leadership team with a proven track record of driving transformational change to address key capability and operational gaps. Second, we accelerated R&D funding. And third, we partnered with Blackstone to further leverage our R&D spend and, with it, expand and accelerate our pipeline. And most recently, we acquired Companion Medical to increase our total addressable market and widen our growth opportunities, moving us from a tethered pump to an insulin-delivery company. We've been missing out on important areas of growth, and we've taken action to fix that. With the Companion Medical acquisition, we're expanding into the largest segment of patients who choose multiple daily injections, or MDI, instead of automated insulin delivery. This population includes a large number of both type 1 and type 2 patients and is nearly 12x larger than the segment of predominantly type 1 patients that we serve today. Our entry into the market segment offers us significant growth potential with earlier access at the point of diagnosis and the opportunity to enable patients to transition from one form of insulin delivery to another as seamlessly as possible. The InPen is the first and only FDA-cleared smart insulin pen on the market. Today, it's differentiated with the connected app that helps guide users on when and how much insulin to dose. In the future, our teams will work to integrate InPen with our CGM platform and leverage our advanced artificial intelligence capabilities to design algorithms that deliver dosing insights informed by multiple factors like metabolism, activity level and insulin sensitivity. People react to food in different ways, and 2 individuals can react very differently to the same meal. Personalization is very important to improving glycemic control. And unlike today where dosing insights are based mainly on the number of carbs consumed, we aim to deliver a higher level of personalized precision-to-dosing intelligence, better guiding users on the right dose at the right time with as little patient effort as possible to further improve health outcomes and quality of life. Ultimately, our goal is to close the loop for MDI patients. We acquired Nutrino and Klue to enable the future of diabetes therapies through artificial intelligence. Nutrino helps us to improve predictive analytic capabilities around meal time and also helps us to identify what's being consumed with greater accuracy. And Klue's jester technology helps identify that food is being consumed. We're taking the best of AI technology and our extensive CareLink database that contains over 500 million days of real-life data with the goal of developing a best-in-class closed-loop algorithm that we can leverage across all of our delivery platforms, both pen and pump. As we build out the intelligence of the system and expand the availability of InPen globally, we're carving out a differentiated market position. Beyond this, we're making excellent progress in advancing key platforms, which Ali will walk you through in greater detail. We've increased funding in our pipeline, leveraging our P&L, balance sheet and Blackstone relationship to expand development of future diabetes technologies and deliver on both near-term and longer-term growth opportunities. I'm confident that these deliberate and focused efforts will help us recapture our technology leadership and drive sustained growth. Let me turn it over to Ali.

Thanks, Sean. With the recent approval of our smartphone-connected MiniMed 770G system in the U.S., we're expanding hybrid closed-loop therapy to children as young as 2. This platform will serve as a gateway to future software updates, security patches and upgrades to new technology as they become available. In Europe, we're super excited about the launch of our MiniMed 780G system, which helps address one of the most vexing challenges for patients, carb counting and meal times. With an algorithm that delivers micro-tailored doses every 5 minutes, the 780G helps keep blood sugars in range by covering for certain inaccuracies in carb counting. It also provides strong protection against lows as well as an improved user experience. It provides the lowest blood glucose target of any automated insulin delivery system. And in short, it's hitting the mark with our customers.

I always get emotional when I talk about this, but I've got type 1 diabetes for 37 years right now, and it hasn't been this good, first time in my life. This system is so easy, easy to use. It really, really works for me. And you see those lovely people on the photo as well. It really works for all of us, and we're all different. So this must be the next step in type 1 diabetes care. It's my opinion, really is.

We hear countless stories like this, which is consistent with what we saw in our pivotal trial and continued access study. We're seeing excellent user experience with optimized settings that leverage the learnings from our trial. At the same time, we're aggressively focused on accelerating our competitiveness in CGM with a multitude of products at various stages of the product development cycle. Starting with Zeus, we've completed our pivotal trial. And while we are looking for the right venue to share the clinical data with the diabetes community, we believe the Zeus data has the potential to support a nonadjunctive claim and a future submission in the U.S. With this, we aim to reduce or eliminate finger sticks for calibration and dosing decisions. What we can share is that the data exceeded iCGM standards for hypoglycemic performance, the toughest zone to achieve sensor accuracy, and showed improved performance, which gives us strong confidence in the progress we're making. We believe Zeus will be a big step forward. And from there, we plan to advance it with our Synergy platform, which will be 50% smaller in profile than Zeus, inserted in 3 easy steps and merges the sensor and transmitter into 1 disposable device. Even in the midst of the pandemic, our pivotal trial enrolled very quickly and is nearing completion. With both Zeus and Synergy, we've taken breakthroughs in machine learning technology, along with our proprietary electro-impedance spectroscopy to enable self-calibration at the point of use. Our new algorithm aims to leverage these advances and multiple sensor signals with the goal of optimizing sensor accuracy. We've also tightened and implemented additional controls throughout the manufacturing process for more rigorous reliability check, which we believe will further enhance performance consistency. You should take away that we're closing the competitive gap in CGM, and it's happening faster than we would have predicted 12 months back. And as Sean mentioned, with our increased level of organic R&D investment, combined with an innovative funding partnership with Blackstone, we have several meaningfully disruptive leapfrog projects in our Diabetes pipeline beyond what we've shared today, all aimed at not just closing some of our competitive gaps but truly advancing our leadership position in the Diabetes technology space.

Thanks, Ali. We have the right strategy and team in place to close our current competitive gaps but more importantly to expand our reach into larger and faster-growing market segments. The pipeline is real, and it's compelling. The deliberate changes that we are making to our strategic focus, organizational structure and capabilities, our leadership team, our culture and operating mechanisms will ensure that we successfully execute on these exciting innovations. Our unrivaled focus in data science and AI will enable us to personalize diabetes management in a way patients want seamlessly, easily and almost invisibly. So patients can enjoy better health and greater freedom. With the addition of InPen, we will be able to expand our reach to patients even earlier in their diabetes journey. Ultimately, our goal is to improve and simplify the management of diabetes no matter how a patient chooses to deliver their insulin. As I outlined before, we've taken a whole new approach to accelerate our revenue growth by aggressively closing our gaps and ensuring relentless execution of our strategy. And we're confident that we're on the right path. Geoff, I'll turn it back to you.

Thanks, Sean. As you can see, we are closing the technology gap between us and our competitors. Now we're not there yet, but I fully expect us to get there, and you'll see the gap closing in the coming year. I also want to say, do not underestimate the opportunity here in smart pens. This opens a whole new market for us and a much larger patient population in TAM. Now let's go over to Neurovascular, another fast-growing market where Medtronic is the leader. Let's hear from Stacey Pugh about our strategy to continue driving not only market growth but our leadership in stroke.

Thank you, Geoff. It's a very exciting time here in the Neurovascular market where we treat stroke, the #1 cause of disability and the #2 cause of death globally. Neurovascular today is a $3.5 billion market that's been growing in double digits for the past 6 years. And the good news is there is still plenty of runway for strong growth. Underlying systems of care are starting to evolve around the world, and this is driving increased patient access. There are lots of opportunities to innovate. We're the market leader with a breadth of products that few competitors have. And we have the momentum and the strategy to remain ahead of competition. Here's Dr. Elad Levy from the University of Buffalo Neurosurgery sharing his views on Medtronic Neurovascular. Dr. Levy?

The Solitaire device is a stentriever that we truly believe is best-in-class. Additionally, from an aspiration standpoint, the React catheter, again, it's robust, it's navigable, yet supple. We can get it where we need to go very quickly and safely and pairs very well with the Solitaire device. So having 2 best-in-class devices, stentriever and Solitaire, React in aspiration, is a very natural reason why we choose Medtronic. Medtronic as a health care partner is very strategic. This partnership has been very personally rewarding and fruitful for the past decade.

Thanks, Dr. Levy. To build on our leadership position, we are pursuing 3 vectors of growth: investing in new technology; partnering across the care continuum; and most importantly, expanding access to therapies around the world. Starting with new technology, product innovation is at the heart of what we do. We've been the market leader in stroke since 2009. From our flagship technologies to our smaller adjunctive innovation that fuel synergy in acute ischemic stroke, we're well positioned to drive continued technology improvement across all aspects of the procedure. We've launched 4 major technologies in the last 5 years, and we are continually reinvesting in research and development to maintain our pace of innovation, both in the hemorrhagic and in the ischemic stroke segment. In our ischemic stroke portfolio alone, we are going to launch a new stent, new aspiration technology and new access technology in the next 12 months. Due to competitive nature of our space, we're going to keep those specifics close to the vest. While continuous product innovation is critical to maintaining our leadership position, it's really only 1 component of our overall innovation strategy. We're always looking for ways to change the paradigm, aimed at improving either patient access or outcome. The stroke market remains underpenetrated because of limited time. Speed is critical to get a patient diagnosed, triaged and treated. And that's where the power of artificial intelligence comes in. We've partnered with Viz.ai to help synchronize stroke care. This LVO uses artificial intelligence to automatically identify large vessel occlusion. This enables on-call stroke teams to be alerted simultaneously, regardless of distance and location. This platform is a first-of-its-kind AI-powered stroke software. And it's been shown to save time, to improve outcomes and to increase access to care for stroke patients. Our partnership with Viz enables us to leverage our deep expertise and our expansive footprint to reach across the care continuum in an innovative and different way, using technology to transform stroke care. We're doubling down on our efforts to expand access to therapy globally. Stroke systems of care are still underpenetrated around the world, and it takes real work and patience to realize the return on true market development and investment. Health care leaders and health care ministers know that we have the expertise and the infrastructure to support them in developing stroke care pathways. From our extensive commercial presence to government affairs and health care reimbursement expertise, these are all critical enablers to driving adoption and reimbursement of a therapy. A great example of this is our partnership with the RESILIENT trial in Brazil. It was just completed and published in the New England Journal of Medicine. We provided support for this study, and it was the first randomized evaluation of acute ischemic stroke in an underdeveloped market. RESILIENT proved that disability is reduced with mechanical thrombectomy even in underdeveloped health care systems. To share more, here is Dr. Sheila Martins, Founder and President of the Brazil Stroke Network and the incoming president of the World Stroke Organization. Dr. Martins?

RESILIENT showed that the treatment can be implemented for 80% of population who lives in low- and middle-income countries. And now the trial will change the lives of people with stroke in Brazil. I would like to thank to Medtronic for a huge and fundamental partnership sponsoring education, research and public awareness in stroke in Brazil in the last 10 years. Thank you.

Thank you, Dr. Martins and the RESILIENT team. This study has made an impact around the world, proving to governments in emerging markets that if they want to go after stroke, if they want to really make an impact on one of the leading causes of death and disability, then they need to be investing in mechanical thrombectomy, technology and treatment. And Medtronic will be there, driving growth and building systems of care. That's the power of Medtronic. In closing, Medtronic Neurovascular is the market leader, and we are in a great position to develop and grow this underpenetrated market where such significant unmet need exists. We intend to build on our leadership position and drive growth by investing in innovation, by partnering across the care continuum and by increasing access to therapies around the world. Real leadership in Neurovascular is going to require multiple capabilities, from innovation expertise to field resources in remote markets around the world. And we are the company that is best positioned to take the field forward, driving growth and helping patients. Back to you, Geoff.

Thanks, Stacey. We have a great opportunity to drive growth in this market. Very few companies have the reach we have in emerging markets, which is where so much of the opportunity resides. Stacey and her team are going after it. We're leveraging our innovation, partnerships and global reach to deliver on this opportunity for patients and for our shareholders. Next, let's turn to our Cranial & Spinal Technologies operating unit, where we're changing the future of spine surgery. The combination of our industry leadership in enabling robotics, imaging, navigation, empowered surgical instruments creates an increasingly powerful competitive advantage for us in this market. Before you hear from Jacob Paul, President of CST, let's introduce 1 of our customers, Dr. Jeffrey Gum from Norton Leatherman Spine Center in Louisville, Kentucky. Dr. Gum?

Thanks so much, Geoff. What 3 words come to mind when I think of Medtronic Cranial & Spine Technologies? I would say, innovators, pioneers, disruptors. Medtronic is a technology pioneer of modern-day spine surgery. They have invested in procedural solutions and an ecosystem, spanning robotics, navigation and data solutions to provide spine surgeons with the most comprehensive portfolio of solutions to improve patient outcomes through innovation. No one else is pioneering on this scale and at this pace.

This is an incredibly exciting time in our organization as we unleash a new business called Cranial and Spinal Technologies, or CST, to organize our entire surgical synergy ecosystem under 1 roof. CST is the recent combination of our Spine and Biologics business, the market leader in implants, with our enabling technologies business, the market leader in imaging, robotics and navigation. So why did we bring these 2 businesses together? Quite simply, the future of spine surgery is, one, driven not just by metal implants and instrumentation but the advanced imaging, navigation, robotics and increasingly preoperative planning aided by artificial intelligence. And this combination of technology, all must work together, resulting in spine procedures that are more efficient and reproducible and ultimately creating value through improved patient outcomes. No other company even comes close to bringing these technologies together in a single ecosystem. Medtronic has market technology leadership across all of these areas with increasingly tight integration between our implants, instrumentation and enabling technologies. And we are establishing our footprint in operating rooms around the world.

The ecosystem that Medtronic has brought forward is really unparalleled. Medtronic has made a great early investment in technology, and we are now seeing that investment pay off with a combination of StealthStation and Mazor. We see these technologies merge together, giving physicians like myself better surgical options for our patients and increased synergy in the OR. Medtronic is, without a doubt, the market leader in this field and continues to drive things forward with the acquisitions and the investments they have made.

As you know, market making is in Medtronic's DNA. While robotics is early in its adoption curve, we are already the undisputed leader with the Mazor X robotics platform at the core of our ecosystem. Robotics is the future of spine care, and we will continue to evolve the robotics experience for surgeons, leveraging our more than 3 decades of innovation in spine- and cranial-enabling technologies by integrating Mazor X with even more of our ecosystem to lead the way. Today, robotics is limited to just 1 aspect of spine surgery. In coming iterations, we'll seek to build upon the benefits as technology can offer surgeons in the OR, increasing speed and improving outcomes. I am pleased to announce that we expect to obtain regulatory approval and plan to debut 2 advances in our robotic ecosystem later this fiscal year. First, the integration of Midas Rex high-speed power drills with Mazor, enabling safe and efficient pilot-hold creation. And second, we are integrating navigated spine interbody devices to our Mazor platform. These added capabilities are the result of a steady cadence of innovation happening at CST, drawing upon our collective knowledge across Medtronic as we embrace the promise robotics offers. We are learning an incredible amount and building off our leadership position in navigation and imaging. We expect these upcoming enhancements and innovations will further differentiate Medtronic and drive greater adoption of our spine portfolio. Sharrolyn is here to tell us more about that.

Thank you, Linnea. Equally important in the surgical synergy ecosystem are the implant technologies that activate them. At Medtronic, we are making bold investments to transform spine outcomes with new innovations in every part of the procedural equation. Let's start with minimally invasive spine surgery, where we are focused on extending our leadership position. We are excited for our global launch of Adaptix Interbody System, the world's first 3D-printed nanotechnology surface implant, fully navigated, which builds off our acquisition of Titan Spine. Couple that with our VOYAGER minimally invasive pedicle screw system, which continues to grow double digits. And to complete the procedure, we have just launched a new biologic with Grafton DBF Inject. Combine all these solutions and you have a seamless, minimally invasive workflow procedure. And we are changing the game for surgeons everywhere. We will be launching our CD HORIZON modular screw system, which is an evolution to enable flexibility in implant delivery and construct design. Another example of Medtronic-leading technologies is the tumor trauma market. Within a year, we have doubled our market share with our T2 Stratosphere expandable corpectomy cage, again, fully navigated. And we're very excited about adding Medicrea's truly groundbreaking technology to our portfolio. With the anticipated closing of the Medicrea transaction by the end of the calendar year, Medtronic will become the leader in personalized implants and AI-driven planning and prediction capabilities, setting a foundation for the future of individualized patient care. We all know that data is the new currency in our everyday lives, and the winners in spine will be determined by those that can harness data to drive better algorithms and outcomes. We intend to lead here, and this is an area where first to market matters. Medtronic is establishing a new standard for true procedural innovation. Let's hear from Dr. Ronald Lehman, a leading orthopedic surgeon, on his thoughts about the potential power of combining Medicrea's technology with Medtronic's Mazor platform.

In my view, Medicrea's portfolio is groundbreaking in a number of respects. Medicrea's database of over 5,000 surgical cases power their algorithm to compute multiple permutations, allowing the surgeon to better understand the patient's alignment before surgery, educating the surgical team of what the plan entails to achieve the ultimate outcome and then provide a [ broad ] bent in the optimal plane to ensure the goals of surgery are achieved. Additionally, we know that not every surgeon has the same training, skill or understanding of spine surgery. Medicrea's artificial intelligence improves much like an iPhone, and that it understands the surgeon's ability and then tailors the plan preoperatively to take all of those independent factors into consideration. The incorporation of Medicrea technology completely changes the landscape for Medtronic. With the most superior robot on the market in Mazor Stealth, combined with the premier navigation system in existence with the Stealth and the ability to perform intraoperative 3D CT reconstructions with the O arm, their technology and ecosystem surpass what others can offer in terms of safety, reliability and precision.

That's right, Dr. Lehman. The landscape in the spine market is changing. And I expect there will be many more spine players on the outside looking in. Simply put, it's a new game now. It's not enough to compete on differentiated implants alone. Actually, it's not even enough to compete with a robot and implants. To win in the spine market, you need a rapid cadence of innovation and a robust ecosystem of enabling technology, all designed to improve patient outcomes. Only Medtronic has that today. And as we continue to innovate, invest and grow, we expect to extend our technology leadership position. We've committed over $2 billion over the past 2 years to accelerate our innovation, and only Medtronic is innovating and investing at this scale across the ecosystem. We are the spine leader across every segment. We are eliminating variation in the OR through our interconnected ecosystem, and we are using data and AI to drive predictability for patient outcomes. In closing, we have the broadest portfolio from implants to enabling technologies to artificial intelligence. Our technology lead cannot be matched. And we are confident in our ability to drive our leadership by accelerating growth and increasing market share. Back to you, Geoff.

Thanks, Jacob. Spine is another business, one of our largest, where we are clearly on the offensive. We've gone from being shared donors to winning share. When I first took over RTG, people are asking if we should even be in this business, but we've reestablished our competitive advantage. And with the combination of spine and enabling tech, our future is bright in this space. Now let's go to Pelvic Health, another business where we've reestablished our competitive advantage. The article in MDDI earlier this week sums it up nicely. It highlights how we've seen a significant acceleration in this business and the overall market, following the FDA approval and launch of InterStim II and InterStim Micro. Here to tell you more is Brooke Story, our President of Pelvic Health.

Thanks, Geoff. In Pelvic Health, we're going on the offensive. We're taking back share with our innovative technology and accelerating growth in this underpenetrated market to give patients their lives back. There are more than 400 million people worldwide living with incontinence. Currently, that's between 4% and 8% of the global population, yet less than 5% of those affected have access to advanced therapies. Patients must try lifestyle changes and drug therapy before they can qualify for an advanced therapy. This is a massive potential market. Right now, in the U.S. alone, 37.5 million people are living with overactive bladder. Of those, 4.5 million are indicated for a third-line therapy, like our InterStim products, yet only 5% pursue treatment. This is a market with significant opportunity. With high prevalence, low penetration and accelerating growth, we are focused on using the expertise of our organization to bring new technologies to the market, utilize the breadth of our product line, expand our clinical evidence and raise physician and patient awareness to maintain our market-leading position. By offering customers and patients the only choice of a recharge or recharge-free system, ensuring better outcomes due to the flexibility of our smart programmer and being the only company to deliver innovation in digital applications and remote health management, we will maintain our market leadership. Medtronic is the undisputed leader in sacral neuromodulation. We pioneered this space in partnership with physicians more than 25 years ago. We've implanted more than 325,000 patients worldwide and have the only 5-year data for all 4 indications. And we know no 2 patients are the same and their therapy should not be either. The new portfolio we launched this year empowers patients to choose the SNS system that best fits their needs. Choice matters. We are the only company to offer choice, with the recharge-free InterStim II and the rechargeable InterStim Micro, and both are full-body MRI conditional. This is also why our smart programmer is customizable. Patients can change settings without having to see their physician. The recharge-free InterStim II gives patients freedom from a recharging routine, recharging components and a constant reminder they have a disease. Alternatively, the rechargeable InterStim Micro may benefit patients who want a smaller, longer-lasting device. We have taken advances in battery technology and microelectronics to develop a rechargeable system that is under 3 ccs in size. So why are so many urologists and urogynecologists coming back to Medtronic? Because InterStim Micro is smaller; faster; and quite simply, better. It's smaller because at 2.8 cubic centimeters, InterStim Micro is nearly 50% smaller than the Axonics device, allowing a tinier incision and less bulk under the skin for our patients. It's also faster. Our battery charges 4x faster than the Axonics device, from 0 to 100% in less than an hour, reducing patient burden of managing their therapy. And it's better because of our proprietary Overdrive battery technology that offers proven results over the conventional lithium-ion battery technology that Axonics is using. This means our battery will have practically 0 capacity fade over time. The Axonics battery will function like today's cell phone batteries and lose the ability to hold a charge over time. In addition, when discharged to 0, the Axonics system has a battery death risk that Medtronic addressed with our Overdrive technology. And let's not forget, we enhanced our evaluation trialing lead, giving patients the best chance for success. It's superior by design to move less than our competitors' trial lead and stay on the sacral nerve. This enables a successful trial for the patient to determine if SNS therapy is right for them. It provides access to the relief they deserve. With the traditional trial leads, if the lead moves from the nerve, the patient won't be able to determine if they are eligible for a permanent implant without additional testing. Let's hear from Dr. Benson from Sanford Health in South Dakota, who's 1 of the physicians who switched back to InterStim after trialing the Axonics system.

I've had the opportunity to use the Axonics rechargeable neuromodulation system, and I found it to be clinically acceptable. I've also had the opportunity now to utilize the InterStim Micro therapy system. And having used both, I'm pleased with the InterStim Micro. It's been reliable. It's been consistent. And it's been effective for my patients. What I do know working a lot with neuromodulation over many years is that one size is not going to fit all. And that the beauty of having a rechargeable system is very appropriate and the best for some patients. Some patients will still do better with a fixed cell battery, and to have 1 vendor that offers both is really helpful for me and the simplicity of my practice. I'm really pleased with the battery technology that Medtronic has put out to market at this point. I think it's going to allow for more satisfaction with patient charging, and I think it's going to allow my patients the confidence to know their device is going to continue to work throughout the longevity of the device. I really like the programming flexibility that the Micro platform allows for. Oftentimes, patients do need to make a change in program. And to be able to do that in a simplified, effective fashion is really a big deal.

We believe Dr. Benson's testimony reinforces the advantages of our product. And finally, our future is bright because we're driving innovation beyond the product. We're unmatched in our investments to improve the therapy and patient access. This includes a significant future focus on increased direct-to-consumer marketing to enhance awareness. We're also confident in our ability to continue driving growth and taking share from the competition because our InterStim smart programmer has unlocked the potential for digital health platforms. This is a huge improvement over the Axonics basic key fob programmer, which is similar to the patient programmer Medtronic had 25 years ago, plus our future digital trialing platform will simplify the patient experience and reduce burn on customers. Going forward, we'll also drive use of our remote case support, so we can deliver excellent customer support from any location, especially in this time of COVID-19. Medtronic is committed to the sacral neuromodulation space, our customers and their patients. No other company can match what we bring to the market. We have the largest and most experienced team in the world dedicated to this space. We have the best technology. And the InterStim portfolio is the best choice for treating pelvic floor disorders. We know how to capture more than our fair share of this growing market. That's why we're winning. We're proud to give patients their lives back. Over to you, Geoff.

Thanks, Brooke. The acceleration in this market and our business in the last 2 months since we've received our FDA approvals has really been remarkable. We estimate market growth this calendar quarter was close to 20%, and it looks like we've already backed 4 to 5 points of share. Next, let's close this segment with Neuromodulation. In both spinal cord stim and DBS, we've revitalized the businesses and are very much on the offensive. Dave Anderson, our President of Neuromod, can tell you more. Dave?

Thanks, Geoff. In the diseases we treat in Neuromodulation, we created the therapies that have alleviated pain, restored health and extended life in millions of patients. And whether it's deep brain stimulation, spinal cord stimulation, targeted drug delivery or interventional pain therapies, we were the first movers. We were the innovators in our space. And over the past few years, these products have generated about $1.5 billion in annual revenues for Medtronic. And they're in markets that collectively are several billion, but they weren't growing. And we were losing share. But now, as we stand here today, all that is changing. After a period of significant reinvestment, we're poised to grow. And through a combination of internal investment and external development, we're leapfrogging the competition, and we're reestablishing our technological leadership in each of these businesses. We're going on the offensive now, with innovation that's launching, backed by clinical evidence like never before, and a robust pipeline of product developments that we expect will sustain that technology leadership for years to come. Today, I'll highlight 2 transformational innovations, BrainSense in deep brain stimulation and DTM in spinal cord stimulation, that are just beginning to unlock a long runway of value. So let's begin with BrainSense. In the treatment of movement disorders, sensing brain signals is the key to therapy optimization so that physicians know exactly where and how to target the therapy. And now we're directly on the path to closed-loop therapy with our BrainSense technology, which will be a real game changer for our clinicians. Our Percept DBS system with BrainSense technology received CE Mark earlier this year and FDA approval this summer. And the launches are off to a great start despite the pandemic. Percept is the only commercially available DBS product on the market that senses brain signals, ushering in a new era of personalized DBS therapy. Our competitors are not even close. Not only that, but Percept PC is the most advanced neurostimulator platform that has 3T MR Conditional, has a smart battery and intuitive engaging programming. More importantly, we've been on this brain sensing journey for more than a decade now, and we'll continue to innovate and offer differentiated solutions as we work towards demonstrating the superiority of closed-loop therapy. To date, patient and physician reaction of Percept has been incredibly positive, exceeding even our expectations. And while these features such as directional leads can be valuable, we're going to bring those to market, too, next year. But when it comes to features that really drive purchase decisions, nothing can compete with BrainSense. Ultimately, it's about the therapy that Percept with BrainSense delivers for our patients and the impact that will have on their lives. The neurology community, clinicians, patients, their caregivers, advocacy groups, everyone's excited about these advancements and how they'll help manage the most difficult symptoms related to movement disorders. With Percept, patients can now capture their symptoms or activities through a digital diary, which will simultaneously be recording their brain state to provide clinicians with those critical insights to patients while they're outside their clinic. I'd like to introduce Dr. Mark Richardson, a neurosurgeon and the Director of Functional Neurosurgery at Massachusetts General Hospital, to talk more about our Percept platform.

Having a window into brain activity during DBS, I think this is something that is potentially really, really important for patients. We already have access to their brain waves, and we're going to exercise personalized medicine.

Thanks, Dr. Richardson. Sensing brain signals is just the first step. And as you can see, we're on a path to transform DBS therapy with the goal of creating that closed-loop system, adjusting therapy based on real-time sensing of brain signals. We're preparing to bring the first and only adaptive DBS system to market, with product development well underway and clinical trials set to begin in January of next year. I've asked Abhi Kulkarni, the Head of Medtronic's Neuromodulation Technology Development Center, to share more about our vision for adaptive DBS. Abhi?

Thanks, Dave. So our vision is that adaptive DBS will deliver personalized and optimal neurostimulation therapy, deliver stimulation when the patient needs it and only as much of it that they need automatically. So for example, consider Parkinson's disease and its symptoms. These are episodic symptoms. They typically fluctuate through the day, and accordingly, the patient's need for stimulation also varies. When the patients are experiencing symptoms, they need stimulation. However, when they are asymptomatic, they have no need for stimulation. Now recent studies investigating Parkinson's disease-related phenomenon have shown a correlation between brain signals recorded from patients suffering from Parkinson's disease, with the symptoms such as akinesia and rigidity that they may be experiencing. So these signals are now akin to a symptom monitor. The brain signal levels increase and decrease as patient's symptoms increase and decrease. Adaptive DBS algorithms will automatically and, in real time, adjust stimulation being delivered to patients based on these brain signals. Patients will receive more stimulation when their symptoms flare up and less stimulation when they wane. Our goal is that this powerful feature will have several potential advantages. It could potentially save battery life, making devices last longer. Side effects could be reduced since stimulation is only being delivered when the patients need it. Now this is what we mean by closing the loop, taking direct feedback from the patient's brain and using it to fine-tune the therapy. The therapy would be delivered automatically and on demand, depending on the patient's need. We believe that adaptive DBS is the optimal way to deliver therapy to patients, and we believe that it will change DBS therapy forever.

Thanks, Abhi. In short, BrainSense is going to transform deep brain stimulation, while establishing a new standard of care, and Medtronic is at the forefront. And we're not stopping there. That competitive spirit and innovative technology expands also to our spinal cord stimulation platforms as well because back pain remains a huge problem worldwide. In the U.S. alone, more than 100 million Americans experienced chronic pain lasting longer than 3 months, costing the nation more than $0.5 trillion annually in direct medical treatment and lost productivity. Pain affects more Americans and is costlier than diabetes, heart disease, cancer. And Medtronic pioneered spinal cord stimulation therapy more than 40 years ago and continues its strong commitment to advance the field. Our recent acquisition of Stimgenics, and then the launch of a differential target multiplexed or DTM, is a SCS therapy uniquely grounded in science, preclinical and clinical research and proven to deliver superior pain relief on the Medtronic Intellis SCS system. To describe DTM in more detail, here is Dr. Ricardo Vallejo, Pain Physician and Director of Research at National Spine and Pain Centers and the inventor of the DTM SCS therapy.

As a pain physician and scientist, I've seen the spinal cord stimulation rising in its importance to treat chronic intractable pain, which affects over 100 million people in the U.S. alone. DTM spinal cord stimulation is a unique and important new algorithm rooted in preclinical science that began with behavioral and molecular studies in animal research over a decade ago. DTM may engage a novel mechanism that electrically modulates neurons and glial cells, modifying their interaction and normalizing their biological processes and interrupting the chronic pain cascade. Preclinical studies show that DTM achieved a statistically significant reversal of pain behavior, but also significant reversal of molecular changes related to this neuroglial interaction action over either low- or high-frequency spinal cord stimulation. DTM SCS is now translated into the clinical setting with a Level 1 randomized controlled trial, demonstrating superior pain relief compared to conventional stimulation at 3 months. The 12-month results will be released later in October, and I look forward for DTM SCS helping many of those suffering with chronic pain.

We're showing you here the 3-month data from our randomized controlled trial that was presented for the first time at NANS back in January. This data show that DTM had superior back pain relief compared to conventional SCS therapy. We found that 80% of patients responded to the DTM SCS therapy compared to only 51% for conventional stim. And most importantly, 63% of patients showed profound back pain relief, which means an 80% or greater reduction in pain compared with just 28% for conventional stimulation. I'm pleased to announce today that we have completed the 12-month follow-up, and they are among the best back pain results in a randomized controlled trial that Medtronic has seen in SCS for the treatment of chronic back pain. The data will be announced next Monday at the Medtronic Global Collaboration of Societies, with Aspen, NANS and World Institute of Pain. Adoption of DTM SCS to date has been very strong. Despite the disruption of the launch by the pandemic, we gained new implant share last quarter and have observed robust DTM trial and implant adoption in the U.S. across all customer segments, the most notable of which are competitive accounts. In fact, we're excited to see that accounts where we've launched DTM are growing faster than even pre-COVID levels. And this is only the beginning of this therapy. We see a significant opportunity to expand the SCS market in the future to include surgical-naïve chronic back and leg pain, upper limb and neck, chronic pain and painful diabetic neuropathy. These indications would more than double the size of the existing market, which is, in itself today, underpenetrated. Medtronic is already investing in 3 RCTs to demonstrate the effectiveness of DTM therapy across these indications. And we're also developing a comprehensive approach to develop therapy to treat painful diabetic neuropathy with an RCT planned for next year. With improved outcomes and pursuit of new indications, we see Spinal Cord Stimulation as a significant growth engine over the next several years. DTM SCS therapy is rooted in science, demonstrated in preclinical research and clinical trials, and proven only on Medtronic's Intellis neurostimulator. Intellis is the smallest spinal cord stimulator on the market, provides full-body MRI access, unlike other competing SCS systems. And in addition, because of Medtronic's proprietary overdrive battery technology, with 1 hour empty-to-full charge times and less than 5% fade at 9 years, we're able to offer an industry-leading 9-year warranty. And for the future, just like in DBS, we're working to bring closed-loop therapy to spinal cord stimulation as well. Let's hear from a patient who has experienced the benefit of Medtronic SCS therapy.

Before I had the stim unit implanted, I was always at like a 12 or a 13, 1-to-10 pain scale. After it was implanted, I was at a 2 to 3, sometimes a 4 on the worst. Now that I have the stim unit implanted, I don't take any medications anymore.

These therapies have a profound impact on patients. As we look ahead, BrainSense and DTM, they're just 2 examples of differentiating innovations that we're using to retake that pole position in these growing markets, and we're doing so with a scientific foundation always. Neuromodulation at Medtronic is back to win with innovation and evidence like never before. Back to you, Geoff.

Okay. Thanks, Dave. It's great to see the significant investment that we've made in pain stim and DBS is starting to pay off. We have a really strong runway in front of us in both of these markets and a great opportunity to drive growth and win share. I hope that these 8 businesses gave you a greater appreciation for how we're accelerating growth and for how we're going on the offensive and winning share. With that, I'm going to send it upstairs, where Ryan is standing by to start the analyst Q&A session. Ryan?

Great. Thank you, Geoff. I do want to remind everyone joining us today that we have a number of materials on our website, including some key takeaways that we're going to be posting after each presentation. So I encourage you to visit the Event page on investorrelations.medtronic.com.

So we're now going to take your questions on these 8 businesses that we just featured in segment 1, which was going on the offensive and taking share. And to join me to answer your questions, I have Mike Coyle, Head of Cardiovascular; Brett Wall, who leads our Neuroscience division; Sean Salmon, Head of Diabetes; and Bob White, who leads Medical and Surgical. And then for the covering sell-side analysts that are joining today that will be asking the questions, if you'd like to ask a question, I'll remind you that to please locate and click on the Raise Your Hand button located in the participant panel, and that will prompt us to know that you're ready to ask a question. So let me take a look at that right now. It looks like a lot of hands going up. Let's start with Vijay Kumar. Vijay, are you there?

Yes, I am, Ryan. So thanks for hosting the virtual format. It's pretty cool. Appreciate the effort that's gone in. I had 2 product-related questions and 1 big picture, if Geoff is around, but maybe let's start with the product side. Mike, I was a little scared when I didn't see you with the new operating unit structure, so it's good to see you in the virtual format. I guess 1 on CRM. I'm pretty curious, you guys said the market's perhaps growing low singles. Along with the commentary of share gains, replacements getting back to, I guess, being a tailwind, can we now make the thesis for CRM being a low to mid single-digit growth segment for you, guys? If yes, what is the time frame we should be looking at for CRM to normalize for you, guys?

So thanks for the question, Vijay. And absolutely, we think we can sustain low to single -- low to mid single-digit growth for that business as we emerge from sort of the COVID environment. And frankly, it has really stabilized in that part of our business to sort of pre-March levels. So we're sitting right now, I think, in a position where the combination of the share capture that Mike mentioned, which is -- which really is a combination of what we're going to talk about this afternoon, the micro impact on brady pacing and then, longer term, the EV-ICD impact on our ICD business. But even more importantly, the new product launches that we've had right across our conventional segments. So conventional, the ORION platform pacing 2 years ago, and now the launches of Cobalt and Crome in the Polaris family. And I think the team did a great job of outlining the feature differentiation of those, which is really responsible for that sort of 2 to 3 points of share that we're capturing versus prior year. And from my perspective, I think what's particularly exciting about that is it's been a bit masked by that replacement cycle issue that we've talked about the last couple of years. And as Mike Marinaro pointed out, whereas that sort of peaked in the FY '19, and we still had significant issues in FY '20, we think this year, FY '21, it actually neutralizes. And as we move into '22, '23, it actually becomes a tailwind for us. So absolutely, we think that mid -- low to mid single-digit growth profile for the overall implantables business is absolutely what we expect out of.

That's actually helpful comments, Mike. And maybe switching next to Diabetes. Sean, some really pretty cool and interesting updates within your field. I guess the one that caught my attention was Synergy enrollment is almost nearing completion. I'm curious on, that when you look at that market rate for Diabetes as a segment, can Medtronic grow it in line with the market? My understanding is, perhaps the market is growing, call it, 20%. Can you guys, post-Synergy launch, get in line with the market? And is Synergy targeting the type 2 market? Do you think your pricing will be similar to what an Abbott's Libre is? Or perhaps thoughts around how you see the CGM market?

Yes. Thanks, Vijay. Appreciate the question. I guess for you -- for late-breaking news for everyone, we actually completed the Synergy trial just yesterday. So I'm really proud of the team. We started that trial back in July and, amidst the pandemic, got it fully enrolled in really record time. Yes. Your question as to what universe will we compete in across the continuum of CGM, I think what I've tried to do is focus the business really on the core business of intensely managed patients who use insulin. So that's both type 1 and type 2, but not really that orally treated type 2 population that I think we'll get to when we make further improvements in our product line, including things like [ wear a life ] and other advantages it could be bringing. But right now, our focus is to get competitive again within our core business, and we expand into type 2 more with other product offerings, including the Companion InPen addition.

And yes, so in the Diabetes, post-780G, do you think you'll be growing in line with the market? Or I guess, if my assumption is the market is growing, we can -- can your -- there's obviously a scale difference here, but I'm curious how you think about the segment growth rates.

Yes. So I think when you kind of break the segments out within automated insulin delivery, and you do that with tethered pump or the patch-type pump, I think those are different segments. We play in that tethered pump business. And I think with the new product approvals, we'll be in line with market growth, and we'll accelerate that through, let's say, the next 4 to 5 years with the other investments that we're making.

That's helpful, Sean. And then maybe one last one, a big picture for Geoff. Geoff, I guess, trying to reconcile your comments around 5%-plus on the LRP top line. I'm just curious on -- because if I look at -- I think the end markets are growing 5%, right? And the theme -- I guess the theme 1 was going on the offensive and taking share. Is the 5%-plus sort of -- the plus sort of a proxy for numbers perhaps coming in better than expected if some of your new products do materialize and you guys are successful? Maybe help us understand. Because this is a pretty bullish analyst here, right? The 5%-plus, help us put that into context. And what's the base for 5%-plus? Am I looking at fiscal 2019 pre-COVID as a revenue base for when I look at 5%-plus?

Hey, Vijay, it's Ryan. Geoff is going to be joining us -- Geoff and Karen are both going to be joining us later in the day for the Q&A session, where I think they'll be in a good spot to answer your question. But I'll just say, I think you're thinking about it correctly. But why don't you save that one for later this afternoon, and we'll have Geoff and Karen answer you directly. But I appreciate the questions, Vijay. Sounds good. And I'd like to remind the analysts, if you can ask one question and one related follow-up, that would be great. Let's go to the next analyst, bob Hopkins. Bob, are you there?

I am. Thank you, Ryan. Can you hear me okay?

We can.

Great. Terrific. Thanks again for hosting today. I guess the first quick question I have is for Sean. I was wondering if you wouldn't mind just going into a little bit more detail about the Companion Medical opportunity and business and, most importantly, the rollout plan. I know it's a pretty small revenue base today, but I'm just wondering how quickly can that technology help Medtronic's Diabetes growth in a way that we'll be able to see?

Yes. Thanks, Bob. Appreciate the question. So we've just finished the integration -- or embarked on this together just very recently. So we're still putting together exactly all the plans. Yes, one obvious place for us to grow this beyond its current trajectory is to take it internationally. And that's going to require a lot of product registration reimbursement work. The work that's been done in the U.S. has gotten pretty broad coverage, where about 80% of the private payers now covering the InPen solution. And we'll, of course, try to drive that a little bit further with deeper penetration, using the combination of the legacy Companion sales force, then introducing that into our larger sales force and support network. So we'll be putting a lot of focus on it, obviously, as we step into this opportunity. And there's been a lot of enthusiasm for it. But I think the real kind of trajectory of growth for that business gets better when we add the things we talked about, the personalization algorithms that work to get better dosing intelligence as well as things like Nutrino and Klue to, again, close down that loop for those self-injecting patients. And I think that appeal will really move a lot more people there. Because, really, what we endeavor to do here is to say that we can give you insights, not just the fact that you need to inject insulin, but how much you have to inject, in a way that's going to be far better than what's possible with any other manually injected solution today. So we'll have some time to build that out. But certainly, there's a lot of interest already building up on the product. Just expanding access will drive growth in the near term.

Great. And then just one quick follow-up for Mike. On LINQ II, I thought it was interesting to hear you guys talk about the opportunities in heart failure from that product. So maybe you could just kind of describe how long will that process take. Is that still a couple of years out? Or is that something a little near term?

Well, actually, we've already started the clinical work on this. So as LINQ II has come into -- yes, out of the development and into production, it has a number of additional sensor capabilities from the original LINQ product, including the ability to measure respiration and impedance, which, in patients who are going through decompensation events, they build up fluid that actually is measurable as a lower level of impedance, and then we can track respiration rates as well. And for a long time, in our therapeutic devices, we have been able to identify markets of impending decompensation events, whether it's the presence of an atrial arrhythmia, whether it's the variations in day-to-nighttime heart rate. These are clear indicators of the patient who is headed into a bad direction relative to their heart failure decompensation, especially if you're looking at a patient who's just recently had a heart failure hospitalization. So now with the availability of this capability in the LINQ II device, we have kicked off a trial called ALLEVIATE-HF, which is enrolling right now, actually, which will basically look to flag patients with a risk score based on the parameters that I just mentioned, as a cumulative group, to be able to identify patients who are sort of red, yellow, green relative to whether they are moving in a direction that would indicate that, over the next several days, they are going to decompensate in the absence of some changes to their medication. And so that trial is enrolling now. We expect that's probably about 1.5 years from being able -- to be able to report out its evidence. But we are very excited that this market that has really been built on the back of arrhythmia detection can now be expanded beyond arrhythmias into heart failure and, as Geoff mentioned, even beyond certain cardiovascular parameters, which we'll probably talk about at future dates.

Great. Thank you, Bob. Let's go next to David Lewis. David, are you there?

Can you hear me okay?

We can, yes.

All right. Well, a couple of quick questions. Maybe one for Nina or Jeff in TAVR, and then maybe a follow-up for Sean. Nina or Jeff, just this head-to-head trial in TAVR is interesting for a couple of different reasons. I mean, clearly, you're targeting your hemodynamic advantages in TAVR. But 2 questions here. One, what is the platform strategy to address some of the coronary access challenges with the Evolut platform and the timing to address some of those? And then more broadly for you, the members of the team in TAVR, it's just these head-to-head trials, you just don't see a lot of these in medical devices. Can we think about this as a new strategy across Medtronic to go after competitively head-to-head studies to illustrate competitive advantages? Then I had a quick follow-up for Sean.

So David, I'll take that question on behalf of the portfolio and on behalf of Nina and Dr. Popma. Basically, you're right. I mean this is a -- this head-to-head trial is a new approach for us. And it has very much to do with the specifics of this case in that, as we know, in a group that has small annular, and we're talking about 30 millimeters or less, putting an intra-annular valve actually creates a constriction, higher pressure drops. It's not good for the patient. It's not good for the longevity of the valve. And we think that there's a real opportunity there to show the supra-annular design. Actually, its hemodynamics will not only translate into short-term hemodynamic benefits but longer-term clinical benefits as well as durability benefits for the patient. And so this strategy, really, we think, allows us to highlight, especially in accounts that have been very heavily skewed to the Edwards technology, that there are patients who really do benefit from this supra-annular design, and we want to prove that to them with unambiguous data. And that's where this direct head-to-head comparison is going to take place. So we've seen a lot of interest in just announcing these accounts, and especially in accounts who were very much Edwards loyalists wanting to see if, in fact, there is a patient population that they are serving that they really could serve better with a different design. And so we're going to be anxious to enroll this study and get to the results. We've obviously had a lot of data from a lot of clinical studies, not only ours, but in looking at the Edwards data that give us a lot of confidence that we'll be able to show this benefit. And then your question about longer-term lifetime management. Nina showed the graphic there in terms of our iterative cadence within the supra-annular design. Our next product line, the Evolut FX, is really going to be focused on the deliverability of the valve and the visualization of the valve. But I think, as you -- and we're on a targeted 18- to 24-month cadence. But as you look beyond that, I think our focus really shifts to this question of lifetime management and how testing the valves can be optimized, how coronary access can be optimized. And we have a number of, really, I think, interesting concepts that are being tested right now. So we think, at the end of the day, the hemodynamic arguments and the durability arguments over our valve are going to become what dominate because of the, frankly, very low risks associated with the coronary access question. But obviously, as we move into less sick patients, low-risk patients, patients who are younger, we want to optimize all aspects of our design.

That's very helpful, Mike. And just, Sean, just a quick one on Diabetes, maybe a couple here. But can Synergy be launched sort of with 780G in the U.S. by the end of this year? And is that system going to eliminate finger sticks or still require a single cal? And should we think about Synergy as really supporting 780G in the near term, Sean? Or can it launch at that same time as a real stand-alone system? Sorry for the several questions there.

Thanks, David. Our goal is to make 780G forward compatible with the evolving center pipeline. So starting with Zeus, having compatibility right out of the gates when Zeus is approved. So that would work. And then, of course, Synergy would be also approved in that vein. For Europe, we're very confident we're going to have no-finger sticks claim for both Zeus and Synergy. And in the U.S., we're going for our filing strategy and claims matrix with the FDA right now.

Okay. Thanks, David. Let's go next to Robbie Marcus. Robbie, are you there?

Yes. Can you hear me?

We can, yes.

Great. Ryan, maybe if you want to quarterback this question. Usually, we get some nice, pretty slides with all the new product launches and time lines going forward. And I realize the hesitancy to maybe do something like that and market growth rates, given the environment we're in right now. But how do we think about the most meaningful near- and mid-term product launches across the business? How should we think about what's impacting fiscal '21 and fiscal '22 the most? There's a lot of exciting products here, but how do we think about the most impactful to sales in the next year or so?

Yes. Great question, Robbie. Maybe what I'll do, because I think we have them across all 4 of our portfolios here, let's start with Mike and maybe just tick off a couple of things, and we'll go right down the line.

So certainly, I think the Cardiac Rhythm group is going to be the biggest near-term contributor because, frankly, all of its major products have now been launched. So the big ones, obviously, are the Micra AV product on top of the existing Micra VR product; the Polaris platform with Cobalt and Crome products, which give us an opportunity to take share in the very large ICD, CRT segment, for all the reasons that were mentioned in the segment; and then LINQ II, obviously, not only gives us the opportunity to clearly differentiate with the fifth-generation device, but right now give us 2 actually price points. So where -- in places like ASCs, where we've seen competitors come in at lower pricing that we've been reluctant to follow with LINQ, we now have a couple of points to play in terms of feature differentiation across those products. But then, of course, the TAVR business is going to be our single biggest growth driver in terms of individual product growth. And obviously, that isn't so much about the Evolut PRO+, although that obviously will be rolling out in other geographies beyond the U.S., but the indications for use expansion and just our field penetration with it. So that will be a huge driver for us. And of course, the one that -- at the back end of your time frame there, FY '22, that we think is going to be extremely exciting for the business is renal denervation, and we're going to speak to that in detail here later this afternoon. But I would also point out, in our peripheral and -- APV business, the recent move into the AV physio creation and maintenance market with the IN.PACT Admiral AV, which we believe is a $300 million opportunity in the United States. And then our acquisition of the Avenu technology, which we think ultimately is a $600 million business, are new segments that will provide growth for us. And then, finally, I'd just be remiss if I didn't mention, on the coronary side, our 30-day DAPT labeling that we've now gotten in Europe. And we will see data on this for the United States and the submission in this area that we think this really provides a highly significant level of differentiation in the coronary space, which is obviously premature, and being able to drive share there will be important.

Thanks, Mike. Brett?

We've had an entire, really, rejuvenation across the Neuromodulation franchise. So if you look at, as Dave mentioned, the DTM therapy, which is in our SCS market, that is very exciting. We're back now to pre-COVID rates of implants and certainly trialing. And we believe that, that technology, certainly, in these de novo patients, is really very exciting for us as we're back on really the offensive there with that particular technology. Pelvic Health, also very similar now, with the InterStim Micro device, the smallest device available today with overdrive battery technology, with 3 Tesla MRI leads. And that's a very exciting market, with growth into the future in the double digits. In addition to that, the Percept device in our DBS portfolio, this is the first device that actually can sense, record and store brain signals. And just as a reference, the ability to hear these signals, it's a million-to-one, the signal-to-noise ratio, and it's an amazing ability to actually seek out these signals and then to adapt the therapy. And we're starting and commencing an ADAPT-PD trial that will look at Parkinson's disease and really test this within patients, the ability to adapt the therapy and change the stimulation patterns based on what's actually happening in that patient's brain right now. If we look at the broader SCS market, additional trials in surgery-naïve, additional trials in upper limb and neck, and then, of course, as we get a little further out in the future, with painful diabetic neuropathy. Those 3 areas actually more than double the market opportunity for the pain market and the pain stim market. So those are very exciting product launches across the franchise. If I go to our cranial and spinal technologies business, we just launched in a limited market, and we'll have a full launch next month of the Adaptix. This is our -- the world's first 3D, surface-modified, navigatable cage system. And this will work with our digital ecosystem that we're putting together across this entire spine surgery continuum. That, along with Mazor, navigation -- navigated-powered surgical products from our Midas Rex group, which will be happening later this year, are all adding to this ecosystem to actually make spine therapy and spine surgery more predictable and to actually have better outcomes. And then, lastly, in that particular space, the Medicrea acquisition. This is a planning system that actually allows us -- which we will hope to close by the end of the year, which actually allows us to have advanced planning capability to actually deliver personalized medicine across this digital ecosystem and personalized implants for specific patients to once again drive to better outcomes. So we have a lot of exciting things across the entire continuum of neurosciences.

Thanks, Brett. Sean?

Yes. Within Diabetes, I think, last week, we actually started our full launch of 780 into Europe, and we're beginning to roll out now 770 in the U.S., which, of course, is the platform that gets the software upgrade to 780 and will be compatible with the pipeline of sensors. Zeus will be a near-term growth driver for us. A little bit longer beyond that will be the Synergy sensor. And in the intermediate time, we, of course, have a lesser-known extended wear infusion set, which allows you to extend the wear safely from what's typical 2 to 3 days to a full week. And that whole kind of system of having a platform of hardware with a better algorithm and an upgradable path, with all that phone connectivity as well as compatibility with the sensor pipeline and the extent of where infusions set, makes the sort of automated insulin delivery system a near-term growth driver for us. And of course, Companion Medical will be starting out right now in the U.S. We'll globalize that, and to make it compatible with our sensor pipeline as well, and then add those other features that I -- we've talked about in the video that really make that a big growth driver. So lots of things stacked up, and that's before we get to the things we've invested in with Blackstone, which are -- will continue the growth trajectory.

Thank you, Sean. Bob?

Yes. Robbie, thanks for the question. We've got a really fantastic portfolio of new innovation coming across. Look, I'll start. We're going to give you an update on the robot here in a little bit, continued really exciting news there. As it relates to the robot, a lot of people talk about digitizing surgery. We're executing it. Our acquisition of Digital Surgery is going very well. We've launched Touch Surgery Enterprise, really excited about what that's going to do. I'm going to talk about the GI business in a little bit as well, really excited about the portfolio in that business. And you heard from Matt, just quickly, a few moments ago, on surgical innovation. And you'd think about building on the legacy of leadership in surgical innovation, and you think about our ability to further penetrate the open stapling market, the circular stapling market, that's $1 billion. You think about ultrasonic dissection, we're a single share player in ultrasonic dissection. And that, too, is $1 billion opportunity. And also inside of Surgical Innovations, we have the ILLUMISITE platform with lung. So across the board, we have 12 new product launches in the patient monitoring business. And so really excited about the portfolio. Really excited about the launches that are coming and a ton of growth ahead of us. Thanks, Robbie.

Great. And if I can, just a very quick follow-up.

Sure.

On the -- one of the things we continue to hear is that hospitals have been under pressure this year. Capital equipment budgets continue to remain questionable. What are you seeing in terms of your -- the response from hospitals on the capital equipment side? Are they still willing to purchase large capital? Are they looking more for volume-based agreements? And do you expect any changes going forward?

Yes. I'm going to have Brett to answer that question.

Sure, Robbie. Thanks for the question. And if you look at what our fiscal Q4 and Q1 were -- those were pretty tough quarters because of the COVID-19 pandemic. But what we've seen now in Q2 is, about halfway through Q2, we've actually -- we're way ahead of the pace that we were in both Q4 and Q1 combined. So we're starting to see some relief there -- on that. Now we believe there will be some continued pressures, but we've offered a number of programs to hospitals. We have about 7 or 8 very distinct programs that we offer into hospitals that allow them to have multiple ways of either placing or purchasing the capital. And we believe by working with them during this time and providing them those options that, that's going to be helpful to them in this particular time. So we're pleased with that. The other thing that we're seeing, as we look at robotics, we have robotic opportunities, both in spine and in cranial. We have a cranial robot as well as small cranial robot. And we're seeing actually those start to uptake again, and we're actually seeing utilization at pre-COVID levels. So the utilization is starting to pick up again. The programs that we're offering are providing hospitals a number of options. And we're now on a track that's better than it was in both Q4 and Q1 combined. And I think we'll see some continued pressure as we move forward for the rest of the fiscal year, but we're actually seeing that free up to a much greater degree than it was in the last quarter and last 2 quarters.

Great. Thanks, Robbie. Let's go next to Joanne Wuensch. Joanne, are you there?

I am. Can you hear me okay?

We can.

Excellent. All right. A specific question for products and then a bigger picture question. I put them both out there. In spinal cord stimulation, you talked about 3 different randomized controlled trials that you plan on running that will double the market opportunity. Is there any way to put a little more detail behind that as it relates to the timing of those trials or trial designs? And then for Geoff, there's a lot of great programs that have been discussed this morning. How do you think about success? How do you measure success? And how has COVID-19 impacted either the timing of these products coming to market? Or you're deeming of this as a good product, let's keep going?

Yes. Thanks, Joanne. I'm going to have Geoff answer that question later this afternoon when he's on the Q&A panel. But I'll turn it over to Brett to answer your spinal cord stim question.

Joanne, thanks for the question. And looking specifically at spinal cord stim, we have 2 trials in the surgical-naïve space, 1 in Europe and 1 in the United States. We expect results from that to come back in 2022. Looking at the upper limb and neck, we also see -- we have 1 trial there. It's actually a pilot trial. We see that results coming from that in '22 as well. And then from there, we'll move on to an IDE and a more advanced trial. On painful diabetic neuropathy, we'll start that early next year, and then we see results from that coming in '23. So it's a -- over the next few years, these trials will come to fruition. And then we'll have significant opportunity there. The surgical-naïve market is about $1 billion opportunity. The upper limb and neck, we see, is about $700 million, and painful diabetic neuropathy, about $1.8 billion. So that -- it really more than doubles the opportunity that we see out there today.

If I can then redirect my big picture question then to the land of diabetes. Sean, I'll ask you, how are you measuring success in diabetes? And same type of thought process. How do you think of COVID-19 changing the timing or pattern of some of these product launches that you -- it looks like -- or sounds like you've accelerated?

Yes. Thanks, Joanne. I think the way we really look at success is maybe a little shift from where we've been in the past, where we were really exclusively looking at what kind of outcomes could we provide for the patients. And that's still important, and we're trying to get the very best glycemic control that we can create. But as importantly, we're treading on equal footing that sort of user experience. And we measure that in a lot of different ways, and -- including a Net Promoter Score for just the overall experience that people are having with us beyond just our product, our service offerings as well. And this really become a big focal point for how we're making those improvements, both in the sort of freedom and lifestyle that people desire as well as how the products function in a way that works. With regard to the cadence of innovation, I think we've made -- we're making very good progress. I think we're really -- internally, we're getting a lot better alignment among our functions, and we're working a lot better together. That was a little bit of a challenge, probably -- or affect the org structure, which we fixed and changed. And I'd say that we did some excellent things on clinical trial enrollment. Maybe there's a lot of patients at home and willing to participate in the trials. We're not hospital-based on our trials so that may be an advantage. But we do know that the particular branch of FDA that we work with is heavily involved in COVID, and it's been good in some ways because we've been very collaborative about what the right kind of cadence is for filing. So we don't stack up too much for them. But they do have a constraint, how much they can get done, and that's a reality for the whole industry.

And maybe if I could just comment, Joanne, on the post-COVID environment for cardiovascular. I mean this has really changed the basis of competition in a lot of ways in a lot of segments of our business. So you heard the discussion in Mike Marinaro's section around the connectivity advantages of being able to do about programming, remote control and interrogation of patients, devices without reps in the room, without doctors in the -- in contact with the patients. And we've seen just a dramatic shift in terms of the focus of what is valued in the technology as a result of the COVID needs. And I would extend that to even features that create lower levels of rehospitalization. I mean TYRX has really gotten significant increase in adoption just during this environment. And many of our clinical studies that would show lower rates of rehospitalization -- for heart failure rehospitalization, or for AF or inappropriate shocks. Those have become much more valuable in the minds of our customers now, now that they see that they need to keep their ICUs clean, they have to clear -- they have to keep their emergency rooms clear. And so it's really been quite helpful in allowing us to reposition the advantages of our portfolio.

Thanks, Joanne. Let's next go to the line of Matt Miksic. Matt, can you hear us? Matt, are you there?

Can you hear me okay?

We can, yes. Go ahead.

Great. Yes. I had 1 follow-up for Mike, as you were just talking to -- talking about cardio and cardiovascular. Just on TAVR, it's a bit of a COVID-era question, and one of the things that's come up, as you may know, is this concern or question over refilling the pipeline of patients in this environment. And you've talked a fair amount about being able to remotely manage some of your patients. Just curious whether you feel like centers are getting their arms around getting patients through the echo catheterization sign off and sort of the pipeline to treatment in that segment? And then I have 1 follow-up, if I could.

You're absolutely right, Matt, that TAVR was one of those areas that we were concerned about being more of an elective procedure, especially as we move into the lower-risk patient population in this time period and the capacity for patients to be pushed out. And of course, back in the March, April sort of time frame, it was hit pretty hard in terms of centers suspending programs and patients not being done and the pipeline not being refilled. But frankly, we've been quite encouraged here of late in terms of the trajectory of the procedure growth. We're right now back to sort of procedural growth rates that are flat compared to last year, which we think is a pretty good place to be, relative to the fact that we still see sort of flare-ups of COVID in various parts of the country. And so the fact that we're back to those levels of a year ago and maybe some modest growth above that with the most recent weeks, I do think it's encouraging that we're obviously getting through the backlog. And we're at least cautiously optimistic that hospitals have become very thoughtful about how to segregate their patients for diagnosis and treatment from the COVID patients when they do flare up, unlike what we were seeing back in March and April. So again, we're cautiously optimistic. We still have a ways to go to get back to that sort of that double-digit growth that we think still sits within the capacity of that low-risk patient population. But at least so far, so good.

That's helpful. And then just 1 follow-up, if I could. There was a couple of sort of frontier or new technologies that have been touched on throughout all of these presentations. And one was artificial intelligence, and the other Matt touched briefly on, on visualization and the opportunity there. I just wanted to -- on AI, if you could maybe -- Jacob mentioned it. I know it's -- Stacey has mentioned it, and the relationship with this AI. Curious to understand the -- how you think about that as a leverageable technology across business lines, or part of Medtronic in the future. And then visualization being a little bit of a new front edge sort of competitive push by the company and, again, the investments that you've made there. Would love to understand what the strategy is there for moving into that space more aggressively over time.

Sure. Do you want me to take it -- take it for [ our ] class?

That would be great, yes.

So thanks for the question. You hit on something really important, and that's AI in general. And if you think about it, we think this is a game changer. So I talked about Digital Surgery, great case in point about how we're using artificial intelligence to capture that surgical video data and then just really extrapolating information off of that. So it's a big piece of it. In a few minutes, you're going to hear from Gio and talk about AI in GI. And I would tell you that we're putting AI in GI when we talk about GI Genius and PillCam Genius, some real breakthrough technologies in visualization. We think surgery is a lot about giving the surgeons better eyes as well. And so our entry into that visualization market, we're really excited about our entry there. We've made some acquisitions. We have some internal development as well. So I think you're right to look at AI. And when we talk about putting the tech and med tech, this is exactly what we're referring to. So really, across the portfolio, whether it's in the GI portfolio, when we think about the surgical portfolio, certainly, when we think about surgical robotics, you're going to see us play pretty big in this spot. So thanks, Matt. And Brett, if you probably want to add some things as well?

Yes. Yes, thanks, Bob. And I'd add that -- a couple of things there. If we look at -- Jacob both mentioned it and so did Stacey in their respective presentations. If I look at -- Jacob -- with the potential and -- hopefully, we'll close the acquisition of Medicrea by the end of the year. When we look at that particular technology, we're learning every single time a spine surgery is done. And now they have a database of 5,000 spine surgeries. That's going to grow over time. And what we're able to do is perfectly plan the spine surgery, perfectly plan the implants and then customize the implants for the more complex surgery. So you deliver truly personalized care to that patient. We integrate that with robotics and the rest of our digital platform, and you get a very, very consistent, very reliable, very -- really comprehensive outcome that improves outcomes over time. Stacey mentioned our partnership with Viz.ai. Viz.ai Is really a very powerful tool. What it does is it really augments the stroke neurologists today. So every single person that comes into a hospital and gets a head CT, that is automatically put through the Viz.ai algorithm. That algorithm looks for large vessel occlusions. And when it finds them, it immediately notifies the stroke neurologist, immediately notifies the stroke team, and sends out to their mobile phone the report that there is a potential large vessel occlusion. What that does is it motivates and mobilizes the stroke team to get to the hospital earlier. It actually puts it to the top of the workflow for the stroke neurologist. So it augments their workflow. And what we're finding in hospitals that actually employ this technology is a 59-minute increase and sooner treatments. So that patient gets treated 59 minutes sooner. And we all know that 1.9 million neurons die every single minute you're under an ischemic stroke. So the power of this is incredible. And every half hour that we improve treatment time, you move 1 point better on the scale of disability. So the power of this is immense. When you combine that with the economic opportunities that reside because of this, because keeping somebody out of disability is extraordinarily powerful. And this is not the only place that we're doing this. We're doing this in aneurysm therapy with Sim&Cure. We have a distribution agreement there, where we're helping physicians size and understand exactly the type of devices that need to be placed in arteries for aneurysm. So we see this, as Bob mentioned, really across the whole portfolio. And this is the beginning chapter of what I think is going to be a really, really interesting book for Medtronic.

Thank you, Matt. Let's go next to Matt O'Brien. Matt, are you there?

I am here. Maybe for starters, on the single neuromodulation side of things. Brett, you mentioned a 20% growth in that market right now. How do we think about the growth rate for Medtronic going forward, given that level of growth in your share taking? And is the funnel building as far as clinicians that you worked with in the past trying to come back to you, given that you have Micro now? And are you having to use any kind of pricing or bundling strategies to get that share back?

Yes, Matt, thanks a lot for the question. And we're actually seeing tremendous growth in that particular area, partly because there was a real backlog in COVID, but that's resolving now, but also because of 3T MRI across our entire portfolio. The other thing that's really important is patients now have a choice. They have a choice between rechargeable or recharge-free, and that's a really important choice. And physicians like to be able to offer that choice. What's happening now with the InterStim Micro introduction, great battery technology. The battery technology, their recharges, you can take that down to a 0 recharge. Because sometimes patients have to do that or sometimes patients simply forget, and that technology will recharge fully and completely about weeks or even months later. So the battery technology is the best on the market today. It's very compelling for physicians to go out and use. In addition to that, the market itself is tremendously large. There's 4.5 million patients a year that drop out of pharmacological therapy, who many of them don't seek, almost all of them don't seek additional -- additional help. So we're actually working very hard to recruit those patients, to inform them about the other opportunities and the other options. So we see this as a very good double-digit grower well into the future. As far as the physicians coming back to us, there's a couple of things they really like about Medtronic. First and foremost, the technology is really, really strong. They have a choice. They can put them on recharge-free experience or rechargeable. And that's really important to patients, as we mentioned earlier. And the fact that we have over 300 people out around the world that we're able to support them and to be able to support this particular technology. Now our pricing remains very strong. We're able to maintain where we are. So we're pleased about that. But we also think we provide tremendous value for that price to patients. And at the end of the day, and I want to touch briefly on just the recharge experience. Medtronic has the, as I mentioned, a very strong battery technology here. The recharge experience is excellent for patients. When they want to recharge the device, they can find our device very easily and lock on to the device very simply. That's not the case with our competitor. And in addition to that, when they do that, the ability to have a recharge experience, where, if a patient is pregnant or if a patient maybe forgets to turn it on or to recharge and the battery drains, to be able to get that battery to go all the way back to where it was when it was first implanted is highly, highly important. And that's the experience that we want patients to have. As we move into this rechargeable market, the last thing we want is a patient to have a bad experience and then have to have an X plant, which has happened in other technologies, and then go for a primary cell device. And that's not the experience that patients want to have. That's not the experience that they deserve. And with the technology that we provide, we're convincing patients that this is a good option. And at the same time, physicians like to have that option available because they can trust and rely on the technology.

And then for Mike Coyle on TAVR, specifically. This all calls about you guys taking share, and you've put a pretty bold claim out there to get to #1 in TAVR eventually. How do you display such a well-entrenched competitor like Edwards with a very good valve? Specifically, how are you going to do that? And then you also mentioned the asymptomatic to severe AS and moderate AS patients, how optimistic would you say you are on the commercial opportunity there?

So a great question. The first thing I would point out is we are the market leader in Europe. And so we've already shown that this -- the approach we've taken with the supra-annular design, the hemodynamic benefits are very well recognized in Europe and have allowed us to retain not only our share, but our share of leadership, despite -- not just the presence of Edwards, obviously, but others who have come into the space as well. So we take that as validation of just the quality of our product and our clinical evidence. But I think, as we look at moving toward the, essentially, less sick patient populations, that, in fact, the hemodynamics are going to come back into play as they did in surgical valves. If you were to ask a cardiovascular surgeon what was the basis of competition in surgical valve selection, it was always the gradient of the valve and the hemodynamic performance of the valve. And that was because of concerns of longevity and patient outcomes long term. So we think we're now beginning to see, as we get clinical evidence further and further out and in more and more varied patient populations that, that is beginning to show as the significant advantage of the supra-annular design. And I think Dr. Popma, who, by the way, is a tremendous addition to our team here did a great job of outlining the data sets that came out at ACC, whether we're talking about bicuspid or small annulus, whether we're talking about the leaflet immobility data, we think all of these show the significant benefit of hemodynamic performance of our valve design, and we will continue to iterate to basically take away objections around lifetime management. So we believe that there is a significant opportunity as we move into these less sick patient populations and just get more data on the actual longevity of these products to differentiate our design. As it relates to the expansion into essentially moderate risk and into the moderately symptomatic and asymptomatic patient populations, we believe these trials will be slower to enroll than what we've seen in the more acute patient populations. But as we see longer-term outcomes in those more sick patients, I think there's just a belief that intervening on these patients earlier before they become, frankly, symptomatic is only going to serve them better in terms of their long-term outcomes with aortic stenosis. So we want to be in a position to participate in that as we have clinical evidence to support it. And we will see as we roll out the clinical study, just how fast we get enrollment in these studies, especially given sort of the COVID overhang that we have right now.

Thanks for the questions, Matt. I think we've got time for 1 more question. Can we go to the line of Josh Jennings? Josh, are you there?

Thanks, Ryan. Can you hear me okay?

We can, yes.

Excellent. Just 2 questions for Mike Coyle on TAVR. Just congratulations on recruiting Dr. Popma on to the team. I just wanted to circle back on the SMART trial. Maybe just, if you could help us think through the percentage of total TAVR cases that -- represented by the small annuli population, surgical literature sometime cites 25%, if not more, but you talk to cardiovascular surgeons -- cardiothoracic surgeons or interventional cardiologists, and they typically cite a smaller number. So if you could help us with that and then help us understand what you think you need to show, because I think the effort here is driven by Dr. Herman's data on prosthetic patient mismatch. And I think there was some, I think, data shown at TVT that didn't show a correlation with mortality, and the story out there, I think is well known about hemodynamic benefits of the core valve platform, Evolut platform, in these small annualized patients. But just the percentage of total TAVR cases and then what you need to show in the clinical trial? And just have one quick follow-up.

Sure. I think you heard Nina reference that this -- what we were calling small annular, so call it, 30 millimeters and below, is -- represents about 40% of the patient population. Of course, the important thing is that every account gets these patients. So if we are able to demonstrate which we think we will, the hemodynamic benefits of this design in those patients, you wind up on the shelf in every one of the accounts that basically is trying to optimize the care for their patients. So that's an important thing for us. The second thing, to the point about long-term patient outcomes, again, there's been 30-, 40-year history of surgical valves, where the correlation between the hemodynamic performance of the valve and the durability of the valve and the outcome for the patient have been clearly established. And in fact, when you talk to the cardiovascular surgeons on the heart team, this is the first thing they think about and go to. And I think the fact that we're still in this first period of where the longest term data is out 8 years, it hasn't been as apparent, but it's becoming increasingly apparent. And I think Dr. Popma did a great job of outlining the data sets that are supporting that view from our perspective in his prepared remarks earlier. So I would encourage you to take a look at those. I think time is on our side on this. I think it's going to validate that hemodynamics are important. We've always known this in valve disease management, and it's now coming apparent just from longer-term follow-up in the TAVR space.

Excellent. And then just lastly, thinking about the aortic regurgitation opportunity, any sense of what percentage of CoreValve/Evolut platform are being used in AR cases? And then just how does Medtronic view the AR opportunity?

Josh, I pride myself in knowing a lot of details in my space, but I think you've just stumped me. I don't know if Sean has a better answer from his experience.

I've got amnesia about TAVR. We have looked at that opportunity a number of times, and that's an off-label indication so we're not tracking the use of it or hadn't been -- the time was involved in the business. But I think there's also some dilation of the aorta. There's some -- other considerations anatomically that make the fit for purpose, needing a different platform than what we have today really, from many competitors. So building a device-specific solution is probably the way to go for AR.

Okay. Thanks, Josh. Appreciate the questions and appreciate the questions from everyone. We're going to have another Q&A session after our second segment, and that second segment is focused on how Medtronic is creating and disrupting big markets. But before we get to that segment, we're going to take a 15-minute break. During the break, we're going to roll some interesting videos on Medtronic. So I hope you stay close to your screens and you find those interesting. So we'll see you back in 15 minutes. Thanks, everyone. [Break][Presentation]

When you think about creating new markets and disrupting existing ones, one of our biggest opportunities is in robotic-assisted surgery. We're leveraging our leadership in minimally invasive surgery, which you heard about earlier today, to enter the surgical robotics market. This market is highly underpenetrated. And our solution is addressing the barriers of cost and utilization. We're now just months away from filing for CE Mark and USIDE, and the excitement is building. Here's Megan Rosengarten, our President of Surgical Robotics, to tell you more.

Thanks, Geoff. We couldn't be more excited about where we are today and our vision for the future of robotic surgery and what that future means for both our customers and for Medtronic. At Medtronic, it's our view that every patient around the globe deserves access to quality surgical care. We believe that robotic technology, paired with data and analytics, can help reduce unwanted variability, improve patient outcomes, and by extension, actually lower per procedure cost, expanding access beyond specialty hospitals and across more borders. And by offering robotic systems alongside open and laparoscopic solutions, we are about to empower surgeons with unprecedented choice and trusted surgical technology and performance. As we discussed with you at our investor event last fall in Hartford, Connecticut, the 2 biggest barriers in the adoption of robotic-assisted surgery today are cost and utilization. We believe our robotic platform, which was developed with input from seasoned health care professionals around the globe will be well positioned to address these issues in a meaningful way for patients and customers. As a modular and mobile solution, our robotic platform can be used more times a day. Additionally, it is designed to help inform the decision-making process and is dynamic in that it can be upgraded as technology advances. And on that note, let's hear from a surgeon who has had the opportunity to test our robotics platform.

So the Medtronic robotic surgical platform is really exciting because it will bring new items available on the market that are specific to that system. One of them is the open console, which will allow the surgeon to more easily interact with the other people on the floor. Secondly, it will have the robotic arms, which will be on a separate cart, which will make that -- it will be more versatile and probably easier to use in multi-quadrant surgery. It will drive innovation. It will drive competition. One of the other advantages of the Medtronic robotic system will be that it will be easier to adopt classical laparoscopic tools like stapling devices, LigaSure, et cetera, on their system, which will probably lead to easier usage and probably also cost saving there. I am a strong believer that the entrance of the Medtronic robotic surgical platform into the market will lead to expanding access for the patients. So I am convinced that this competition will lead to broaden the market of robotic surgery worldwide.

Thank you, Professor Mottrie. We appreciate your time today and your partnership as we take robotic surgery to the next level. For a robotic system, we continue to target regulatory milestones of CE Mark and USIDE filing in the first calendar quarter of 2021. We also continue to expect the incremental revenue growth contribution ranges that we shared at our investor event last fall in Hartford. And while we're making great progress as we move towards commercialization of that first robotic system, I am also so excited to announce that we're entering the robotics market now with the launch of Touch Surgery Enterprise. Touch Surgery Enterprise is an extremely easy to use surgical video capture solution, paired with the computer and connected to the cloud, all in a very small package. It allows surgeons and hospitals to securely and seamlessly access surgical videos and data right after surgery on their mobile device or computer. The AI-backed analytics also help surgeons prepare for the next case and identify unwanted variability across procedures. We believe surgeries can become safer and more cost-effective when surgical variability is reduced. And while Touch Surgery Enterprise is going to have an impact in operating rooms now, it's also an important component of our overall strategy to enter and win in the robotic surgery market. Today's touch surgery installations will support the acceleration of placements of our robotic system, once cleared, allowing customers to realize the combined value of our surgical robotics and data and analytics solutions. We're confident that the customer experience with our Touch Surgery Enterprise network will translate into excitement and demand for our full robotics platform and also benefit our existing surgical innovation business. And this is only the beginning, the first launch in a robust data and analytics innovation road map as we build a secure digital ecosystem in the operating room with the goal of driving new levels of clinical and economic value for customers and better patient outcomes. Our focus on robotic-assisted surgery, along with data and analytics, will yield a continuous cadence of product innovations that solve problems and continue to redefine surgical standards. And an important portion of our robotic product innovation cascade will be advancing and introducing more AI-backed solutions. The intersection of surgical video data, artificial intelligence and visualization made possible by Touch Surgery Enterprise opens a world of opportunity to enhance surgical decision support through solutions such as instrument identification, critical structure definition and tumor margin detection, all of which further our work to expand access to quality care and reduce variability.

Medtronic, building a new robotic system is investing a lot in AI, big data, data analytics. And I believe that these 3 topics are the future in the whole medicine in general, but especially also in surgery, specifically. It will help us, to drive us easier through the surgery and would also help us to look at our results and compare them, with them in afterwards, resulting in better outcomes for our patients.

We believe access to surgical data and analytics will make surgery more efficient, safe, affordable and consistently delivered around the world. Pair that with our robotic-assisted surgery platform, and it's clear to see how we will fundamentally disrupt this fast-growing market. We've only just scratched the surface of this opportunity, and we are confident about our future and the tremendous potential for market expansion. And that's it for me. Back to you, Geoff.

Thank you, Megan. Data and analytics is the next frontier of surgery, and we're thrilled with the progress we're making with Touch Surgery Enterprise. And with our soft tissue robotics system, we're excited as we move toward commercialization. We're looking forward to disrupting this market and taking advantage of the significant opportunity to increase robotic surgery penetration. This is a huge opportunity for Medtronic. Another massive opportunity for Medtronic is renal denervation, where we're working to create a new multibillion-dollar market for hypertension. Here's Jason Weidman, our President of Coronary and Renal Denervation, to share more.

Thanks, Geoff. Hypertension affects 1/3 of adults globally and is the single largest contributor to death. About half of all diagnosed patients are not adherent to their medical therapy within a year of initiating, and about 2/3 remain uncontrolled despite the availability of pharmaceutical drugs. This really underscores the need for an alternative tool to fight hypertension. And Medtronic's differentiated approach is renal denervation, or RDN. Renal denervation is an ablation procedure where nothing is left behind. Our unique Spyral RF catheter targets the nerves leading to the kidney to reduce overactive signaling. This simple procedure has safely demonstrated significant drops in blood pressure in multiple sham-controlled randomized trials. Medtronic has an extensive renal denervation clinical program. And I'd like to introduce Dr. Jeff Popma, our Chief Medical Officer, for the Coronary, Renal Denervation and Structural Heart businesses to discuss this topic. Jeff?

Thanks, Jason. We're making great progress on developing the body of evidence that will be required for regulatory and reimbursement approvals. Medtronic is in a strong position for FDA review and payer discussions of our renal denervation system. Due to clinical data from the Spyral hypertension off med pivotal study, which had its primary efficacy endpoint and had no safety signal, continuing the strong safety profile across the entire clinical program. We reported office blood pressure reductions of just under 10 millimeters of mercury, which was statistically significant and highly clinically meaningful and mirrors what we saw in the off-med and on-med pilot studies. The off-med study provides scientific data demonstrating that renal denervation works to lower blood pressure. I'm sure you're also wondering if the effect of renal denervation lasts or does it fade over time. Recent data from the Global Simplicity Registry Study demonstrates durability, with reductions of blood pressures of just under 17 millimeters of mercury at 3 years in a real-world population. By the time of submission to the FDA, we will have prospectively powered sham-controlled data in both the presence and absence of background anti-hypertensive medication as well as real-world durability data from our patients in our global simplicity registry study. In terms of new evidence generation, we recently launched the SPYRAL DYSTAL Study, which is focused on a faster and more targeted procedure. And I'm pleased to announce to you today that we will soon commence GSR Define, an expansion of the nearly completed global simplicity registry, which will provide continued data collection in a real-world setting. I'll also share with you today that we plan to initiate a study called Affirm, which will enroll a broad population in the United States and collect data on typical treatment pathways. Back to you, Jason.

Thanks, Dr. Popma. I'm really glad to have you on our team at Medtronic. So RDN has the potential to be a very large market. Physicians are likely to refer patients with more severe hypertension or for those individuals whom several drugs have already been attempted. Over time, though, we expect the population to expand as longer-term data become available on even more patients, and there is further appreciation of the patient voice in their care. We see attractive opportunities for RDN in the U.S., Europe and China, all of which have massive unmet needs in hypertension. Globally, we believe RDN will be a $1 billion market by 2026 and could be a $3 billion market by the end of the decade, which represents less than 1% penetration of the total hypertension market. When it comes to seeking regulatory approval, we are doing everything possible to speed access to the technology and the procedure. And we are finalizing the collection of a broad evidence set to support the appropriate use of Spyral in the hypertension care pathway. We recently restarted enrollment in our Spyral HTN on-med clinical trial, which we will combine with our off-med data to seek FDA approval. While enrollment speed will certainly be a key factor in determining our approval time line, our goal, as we sit here today, is that we'll be in position to present the on-med data at a major medical meeting in calendar year 2021, followed by a U.S. approval sometime in calendar year 2022. I also want to mention China, which is a big opportunity for us. Aside from a very large population, China also has relatively few patients at their blood pressure goal with only 16% controlled, highlighting the need for new approaches for hypertension management. Specifically, we've identified that there are 1.5 million patients with high blood pressure above 150 millimeters of mercury that are already on 3 or more drugs. We're very pleased to announce today that RDN has been granted the green channel approval process, which positions us for approval in China within a few months of a future U.S. approval. Concurrent with the regulatory work we are doing, we are also taking steps to prepare for commercialization where RDN is not approved and to build the market by working towards favorable reimbursement, care pathway implementation, referral linkages and direct-to-patient initiatives. For reimbursement, we've been in early and frequent discussions with payers around the world about our evidence strategy. In the U.S. specifically, we have been working with both private payers and CMS, where our body of evidence has been favorably received. We are pleased to see that the recent proposed rule from CMS would provide 4 years of Medicare coverage upon FDA approval for breakthrough devices like our RDN system. Regarding the care pathway, several clinical consensus statements have recently been drafted by multidisciplinary physician groups in Europe and Asia where the technology is already approved. The current consensus from the clinical community is that RDN should be used when prescribed drugs have been unsuccessful in controlling patients' blood pressure or when a patient isn't able to adhere to medication, all with a greater preference placed on patients with higher cardiovascular risk. To establish the referral linkages, we plan to collaborate with procedureless hospitals to establish hub-and-spoke referral networks. Finally, we are enthusiastic about our direct-to-patient opportunities as we have found success in enrolling our clinical trials by reaching out directly to patients. We have learned that a large portion of patients are highly, highly motivated to find an alternative like renal denervation. Let's hear from a couple of those patients, Fred and Gale, who sought an alternative to managing their hypertension. [Presentation]

In summary, following the positive off-med pivotal data and the durability demonstrated in our GSR study, we are very optimistic on the future of renal denervation. We are excited to be on the path to bringing this technology to key markets and providing the evidence to support its usage in the hypertension care pathway. There are a large number of patients that can benefit from RDN. And our solution will fill a significant unmet need in the care continuum and over time, be a sizable and important market for Medtronic, a $1 billion market by 2026, with the potential to be a $3 billion market by the end of the decade. We are really looking forward to leading the next big market opportunity in cardiovascular devices. Back to you, Geoff.

Thank you, Jason. Very exciting. We've been on the journey to bring an RDN solution to market for some time now. And with the on-med data expected in calendar 2021, and expected approval in calendar 2022, we're close. We're close to unlocking this multibillion-dollar opportunity. Next, let's shift gears to cardiac ablation solutions, where we're bringing disruptive technologies to market. Disrupting is nothing new for this business as we've been doing it for years with our Arctic Front cryoballoon. Now with the development of our DiamondTemp RF catheter, followed by pulsed field ablation, we're poised to bring leapfrog technology to this fast-growing EP ablation market. To share our plans, here's Rebecca Seidel, President of Cardiac Ablation Solutions.

Thank you for the introduction, Geoff. Medtronic has a strong history of developing new markets in electrophysiology, as shown by our success with cryoablation and our market position in anatomical ablation. Over the past 12 years, Medtronic has grown this business from less than $50 million in fiscal year '08 to approximately $700 million last fiscal year on back of a single technology. In the decade ahead, we aim to dramatically increase our presence in the broader $6 billion EP market. This is a fast-growing market, and we expect the market to grow to more than $8 billion by 2024. We will accelerate growth, and our goal is to capture significant market share by delivering disruptive innovation to treat all arrhythmias and serve 100% of the EP ablation market. This starts by expanding into exclusive cryo indications, then globally launching our DiamondTemp system and finally, disrupting the market with our pulsed field cardiac ablation system. Let's start with cryo. Today, the Medtronic Arctic Front cryoballoon is the physician-preferred catheter for anatomical ablations, essentially ablations that target lesion delivery to the pulmonary veins. Additionally, we have the only focal cryoablation catheter on the market. More than 800,000 patients in over 80 countries have been treated with Medtronic cryoablation therapies, but there are many patients who still need treatment. Medtronic recently received FDA approval to treat patients who suffer from persistent AF with the Arctic front cryoablation system, the first system to achieve this indication. In addition, Medtronic plans to submit first line therapy indication expansion in the fall of 2020. And we believe we have the potential to become the first company indicated to treat AF patients with cryoablation as a first line therapy. This would remove the criteria for drug resistance which delays a patient's time to ablation as they trial 2 to 3 antiarrhythmic drugs before being referred for an ablation. The data set that we'll be using to seek first line therapy indication expansion is the Stop AF First randomized controlled clinical trial, which was recently presented at the European Society of Cardiology. This data demonstrated that Medtronic cryoablation superiority was 75% freedom from AF, compared to only 45% freedom from AF for antiarrhythmic drugs at 12 months. The trial also met the primary safety endpoint, reinforcing the strong safety profile of cryoablation. Today there approximately 38 million patients worldwide diagnosed with atrial fibrillation. These new clinical results have the potential to support early intervention with cryoablation, which would increase the addressable market for AF ablation by 6 million patients. These patients would have the opportunity to benefit from Medtronic ablation therapies upon approval as a first-line therapy. Building on our strategy to treat all arrhythmias, the DiamondTemp system, a powerful and differentiated RF catheter, is another step forward in developing disruptive catheters to transform the treatment of cardiac arrhythmias. The DiamondTemp technology is currently under review by the FDA. It is designed to provide accurate temperature sensing with a closed-loop algorithm to provide real-time power modulation and ensure durable and precise ablations. The state-of-the-art algorithm is made possible by novel diamond-cooling technology and split-tip, high-resolution electrodes. These technologies cannot be found in any other ablation catheter. With other RF ablation catheters, physicians have to rely on surrogates like contact force to provide feedback on tissue temperature, which could sacrifice safety and effectiveness. We've launched the DiamondTemp in limited European markets and are collecting the evidence needed to receive regulatory authorizations to expand its launch around the world. We are in the process of seeking FDA approval, and if approved, targeting a U.S. launch in the first half of calendar year 2021. The DIAMOND AF I trial, which looked at patients with paroxysmal atrial fibrillation, is complete, and we anticipate publication soon. The second trial, DIAMOND AF II, is focused on studying DiamondTemp in patients with persistent AF and will complete enrollment this calendar year. I'd like to now have Dr. Atul Verma, a practicing electrophysiologist, highlight the advantages of the DiamondTemp technology.

The DiamondTemp advantage is being able to deliver more efficient lesions in a shorter period of time. If we can reduce the duration of these procedures, that puts our patients under much less anesthesia. It helps their recovery period. Hopefully with more efficient lesions, it also means more successful procedures.

Thanks, Dr. Verma. Next, let's turn to pulsed field ablation, or PFA, which we believe could completely disrupt the $6 billion EP ablation market. Medtronic is leading the development of this investigational new technology. PFA is a novel energy source that is nonthermal, meaning there is no heat like RF or extreme cold like cryo. Our research teams have spent over 10 years developing an advanced algorithm to support the delivery of these novel electrical wave forms. And the Heart Rhythm Society recently recognized our PFA publication as the seminal article of 2020 that most contributed to major advancements in treating cardiac arrhythmias. PFA uses pulsed electric fields to ablate cardiac tissues through irreversible electroporation. Rather than heating or freezing the cells, the electrical fields destroy the cardiac cells, causing the arrhythmia by making the cell membranes permeable, which leads to cell death. Through a complex proprietary algorithm, the electrical fields have been programmed to target heart tissue and, therefore, minimize collateral damage to surrounding tissues, which may improve the safety of ablation procedures. This is a key advantage of PFA. In addition, PFA may also allow for more flexible catheter placement with the potential to enhance the opportunity for clinicians to perform more complex ablations like VT. Importantly, PFA does not require tissue contact because it's field-based. This means lesions can be created in areas that are difficult to access with traditional ablation catheters that require direct tissue contact. Finally, PFA delivery is extremely fast, allowing for ablations in milliseconds compared to minutes for other energy sources. This is important for procedure efficiency in treating the growing population of patients in need of a cardiac ablation. Dr. Rob Kowal, Medtronic's Chief Medical Officer for Cardiac Ablation Solutions, will now discuss the clinical activities supporting PFA. Rob?

Thank you, Rebecca. The initial results of the Medtronic Pulsed AF pilot study were presented in a late-breaking session at the 2020 Heart Rhythm Society Meeting. Pulmonary vein isolation was achieved in 100% of patients studied, and there were no complications such as phrenic nerve injury, tamponade or stroke. When complete, the study will report the rate of arrhythmia free survival at 12 months, along with other outcomes, such as quality of life and the arrhythmia-related symptoms. We are going to keep moving forward. We've received breakthrough device designation from the FDA and anticipate first enrollments in the Medtronic PULSE pivotal trial early next calendar year. Pulsed field ablation has the potential to create a paradigm shift in how all cardiac ablations are performed. Once the benefits of PFA are established clinically, we anticipate that most electrophysiologists will transition a majority of their ablation procedures to Medtronic's pulsed field ablation solution. Now let's hear from Dr. Devi Nair, a leading electrophysiologist and scientist, on how the Medtronic Cardiac Ablation solutions product portfolio will support a winning strategy for physicians and their patients.

Cryoablation has come out to be an unquestionable alternative in treatment of atrial fibrillation and providing durable pulmonary vein isolation in our patients with symptomatic atrial fibrillation. I think the quest for ablation modalities that can help achieve durable lesions has been an arduous journey. And I think pulsed field ablation is going to be coming forward as an excellent alternative that provides selective electroporation to myocardium and achieve that target. I think Medtronic has been known to collaborate very closely with physicians in providing the best care to our patients. And I think technologies such as DiamondTemp ablation technology and pulsed field ablation are going to be the next steps in providing that safe and efficacious care for atrial fibrillation patients. And so I think that is going to be the future, and Medtronic is going to hold hands with physicians in that step.

Thank you, Dr. Nair. Together, these 3 technologies, arctic front cryoablation, DiamondTemp RF ablation and pulsed field ablation will span the entire $6 billion EP ablation market and position Medtronic to treat a large untapped patient population that needs intervention, and of course, gain significant market share in the process. Additionally, our expansive clinical evidence portfolio, supporting the safety and efficacy of our products is unmatched by the competition. To wrap it up, we have the strongest pipeline of innovation in the history of this business to address the needs of our customers and patients. And we're confident in our ability to accelerate growth with expanded and exclusive cryo indications, the global launch of DiamondTemp and then disrupt the market with our pulsed field cardiac ablation system. Back to you, Geoff.

Thanks, Rebecca. Our pipeline in cardiac ablation is unmatched, and we have a great opportunity to disrupt and earn a much larger share of one of the better growth markets in medical devices. Another new big opportunity for Medtronic is in peripheral vascular, where we're bringing technology together for end-stage renal disease patients. It all started with our IN.PACT AV drug-coated balloon, which we launched in the U.S. Last November. The IN.PACT AV DCB is for maintaining AV fistulas. And now strengthening our position with the addition of the Ellipsis system for AV creation through our acquisition of Avenu Medical. Combined, they represent $900 million in TAM in the U.S. alone. To tell you more, here's Mark Pacyna, the GM of our Peripheral Vascular business.

Thanks, Geoff. Medtronic is committed to transforming the management of vascular disease. As such, we are investing in innovations to grow our core peripheral and venous therapy markets, while also identifying and developing new market opportunities such as deep venous disease, vascular embolization and arterial venous access or AV access, among others. All of these are aimed at accelerating our above-market growth. Today, I'd like to focus on one of our future growth opportunities in our peripheral business for end-stage renal disease, as we help address treatment challenges associated with AV access. This not only encompasses access, maintenance procedures, where drug-coated balloons play a role, but also the exciting new market of percutaneous AV fistula creation. The dialysis market is large and growing with over 2 million dialysis patients globally. The vast majority of patients with end-stage renal disease have to undergo dialysis about 3x per week to remove excess water and waste from their bodies since their kidneys are unable to do so. Typically, these patients require the creation of an AV fistula, a surgical procedure that connects an artery to the vein in the arm to enable an access site for dialysis. Let's hear from Terry Litchfield, who is President of Access Solutions, and a patient advocate helping patients and their families navigate kidney care.

Kidney patient connects to the kidney machine through an AV fistula, we call it their lifeline. And one of the things about lifelines and AV fistulas, is that the technique to create them surgically is 50 years old. Many things in life have changed in 50 years, but the AV fistula has not, at least not until several years ago when a percutaneous fistula creation was approved by the FDA. And what that means for kidney patients is instead of surgical fistulas, unfortunately, we have a very poor success rate. Overall, of the surgical fistulas that are created, it is estimated that less than half are actually ever able to be used consistently for dialysis. The other thing I'd like to mention is that once you have a working AV fistula, it doesn't mean that it's going to function without problems. And so what will happen over time, because these are very high flow vessels, you'll get to develop a stenosis, which is a blockage in that vessel, which really will affect your dialysis. And the current treatments that have been done for years have actually been the use of angioplasty balloons as well as stents. And they aren't particularly good treatments. So 4 to 6 months after having an angioplasty to keep your dialysis access open, you have to go back and get it done again. Fistula failure is a real problem for dialysis patients. And it involves having sometimes the same procedure over and over again. Having repeat angioplasties or stents is not a good use of our health care resources. It's not good for patients. It's not good for dialysis centers that get their schedules interrupted. And it's certainly not good for anybody involved in dialysis today.

Thanks, Terry. In November 2019, we received FDA approval for IN.PACT AV, which was a significant milestone as it was the first approval of a drug-coated balloon in a new vessel bed since the paclitaxel safety panel. IN.PACT AV is disruptive to the standard of care, which is percutaneous transluminal angioplasty, or PTA. And our IN.PACT AV is differentiated from other DCBs for several reasons. First, IN.PACT AV is the first and only DCB in this vessel bed to meet both its safety and efficacy endpoints, providing physicians and their patients with a much needed technology to improve access and reduce disruptions to care. The 6 months pivotal data from the IN.PACT AV access trial, which was recently published in the New England Journal of Medicine, demonstrated that Medtronic IN.PACT AV DCB can cut the number of reinterventions required to maintain vessel patency or keeping the vessel open by more than half. The data also reinforced the safety of this paclitaxel-coated device in this vessel bed. Through 12 months, there was no difference in mortality rates between the IN.PACT AV DCB and PTA. Lastly, because of its differentiated clinical results, IN.PACT AV has the potential to reduce cost to the health care system. Results from 2 recent economic evaluations presented at the LINQ and SIR medical conferences, demonstrated that treatment with the IN.PACT AV DCB could lead to substantive savings. Another treatment challenge that exists today is the creation of AV fistulas. This procedure is typically done via open surgery. Two weeks ago, we announced that we intend to acquire Avenu Medical, a privately held medical device company which has developed a minimally invasive, efficient and cost-effective solution to challenge the standard of care. Avenu's Ellipsys Vascular Access System is an innovative, image-guided single catheter system used to percutaneously create an AV fistula for hemodialysis access. It addresses a critical treatment problem that exists today, creating effective AV fistulas quickly in patients with desperate need for this lifeline. Let's hear from Dr. Jeffrey Hull, as the co-founder of the Ellipsys System and a pioneer of percutaneous AV fistula creation. He can tell us a bit more about the Ellipsys system.

Ellipsys Vascular Access System creates an immediate and durable connection between an adjacent artery and vein. The system uses ultrasound guidance to insert a catheter through an arm vein that is then advanced to an artery, creates an anastomosis. Unlike surgery, there's no incision or suture, the patient leaves with a bandage just as if they had their blood drawn. The benefits of the Ellipsys Vascular Access System are its ability to create high-quality fistulas is that are ready for use quickly and have excellent long-term patency and will potentially lower costs. While we believe the Ellipsys Vascular Access System is better than other devices and techniques that have been used in that it's easier to perform and it has lower complication rates. I'm really excited about the opportunity with Medtronic, bring the Ellipsys Vascular Access System to more patients in the United States and throughout the world.

Ellipsys is available in the market today in the United States and Europe. Medtronic will enable the global commercial expansion of the Ellipsys system in key geographies over time, leveraging the expertise of the Medtronic commercial and clinical teams to achieve broad adoption of the technology. Medtronic has a long history of creating new markets by converting surgery into minimally invasive endovascular procedures and this investment is another example of how we are poised to do this again. We're optimistic on the growth potential of the Ellipsys system due to its advantages over the current standard of care of open surgery. Additionally, in the recent study, Ellipsys percutaneous AVS demonstrated significantly shorter procedure times without a need for radiation exposure and with superior secondary patency compared to WavelinQ. The Ellipsys system is an innovative AV fistula creation technology, and it nicely complements our best-in-class IN.PACT AV DCB for AV fistula maintenance. And we are really looking forward to unlocking this combined market globally, which in the U.S. alone represents a $900 million market opportunity. Back to you, Geoff.

Thanks, Mark. Avenu is a great example of what Medtronic does with tuck-ins. We acquire a highly differentiated technology that complements our existing technology, and we use our clinical expertise and global footprint to advance it to standard of care. Another new market where we're preparing to change the standard of care is in the treatment of mitral and tricuspid regurgitation. We're building off our experience in TAVR. And through a combination of internal R&D and external investments, we're bringing forward a differentiated portfolio of technology in this space. Here's Nina Goodheart again to tell you about this exciting multibillion-dollar opportunity.

Thanks, Geoff. The next revolution in Structural Heart disease is transcatheter mitral and tricuspid therapies. At Medtronic, we're building a portfolio that has the potential to disrupt the current standards of care and win in this new multibillion-dollar market. We're approaching this market by building differentiated replacement and repair technologies to drive Medtronic to global market leadership in Structural Heart. We're confident that we have the innovative product portfolio, strong organization and technical core competencies to succeed. Fundamentally, the growth in transcatheter mitral and tricuspid therapies is driven by a large unmet patient need. Over 20 million patients suffer from mitral and tricuspid regurgitation in the developed markets, more people than the populations of New York City, Los Angeles and London combined. While the market today is being established by edge-to-edge repair, we continue to believe that a toolbox of repair and replacement devices will be required to effectively treat this diverse patient population. We expect the combined mitral and tricuspid market to grow from $800 million today to over $3 billion by 2025, as novel therapies provide physicians with treatment options for these highly underpenetrated disease states. Medtronic is leading the way in transcatheter mitral valve replacement with our investigational Intrepid device. We believe the design of the Intrepid valve provides unique advantages over other percutaneous therapies for patients and implanting physicians. The dual stent design decouples anchoring from valve function to address the complex anatomic and physiologic challenges of both mitral and tricuspid valves. It also anchors in the anatomy without having to capture the valve leaflets as they move rapidly in a beating heart. The goal is to simplify the procedure and reduce dependence on advanced interprocedural imaging. Globally, we've treated approximately 300 patients with the Intrepid system and have follow-up to nearly 5 years for the first patients. While the early clinical experience with the Intrepid valve has used transapical access, which is done by puncturing the apex of the heart, our strategy has always been to pivot to the less-invasive transfemoral delivery route. The transfemoral system is now in clinical use in an early feasibility study. We've recently modified the design of the APOLLO trial. Rather than a 1:1 randomization of Intrepid versus surgery, our new single-arm design will enroll patients who are not optimal candidates for an approved transcatheter repair or mitral valve surgery. We have aligned with key thought leaders and global regulators to define this patient population and the trial's performance goal. At the same time, we'll continue to enroll the announced registry for patients with mitral annular calcification and are pleased with the performance of Intrepid in this challenging anatomy. This redesign is also anticipated to accelerate enrollment of the Impella trial. By pursuing these targeted patient populations, we expect to accelerate enrollment and commercial application. Turning to the tricuspid market. The treatment of tricuspid valve disease promises to create yet another large Structural Heart market. We expect it to exceed $200 million by 2025, with robust long-term growth driven by the prevalence of untreated disease. In the U.S. alone, there are nearly 2 million patients suffering from moderate to severe tricuspid regurgitation. Because of the progress we've made in designing our transfemoral system, we're able to leverage the same intrepid design that we're studying in clinicals on the mitral side as a future treatment for tricuspid disease. Last month, we announced we received breakthrough device designation from the U.S. FDA, and they approved an early feasibility study to treat patients with tricuspid regurgitation with the Intrepid system. We are already enrolling patients and expect the first implant as part of the study in the coming weeks. In addition to our Intrepid replacement program, we're excited to disclose for the first time today the work that we've been doing in mitral repair in conjunction with The Foundry. For those that are not familiar, The Foundry has a track record of disruptive med tech innovation, including 2 successful ventures to treat mitral disease: Evalve, which invented MitraClip; and Twelve, which invented Intrepid. In mid-2017, Medtronic invested seed capital and intellectual property in Half Moon Medical, the 16th portfolio company of The Foundry, with the goal of developing an innovative mitral repair technology. Pending the achievement of technical and clinical milestones by Half Moon, the structured arrangement provides for additional investment tranches from both Medtronic and The Foundry, with Medtronic holding an exclusive right to acquire the company upon the achievement of the final milestone under the development agreement. Half Moon's agile design and development process led to the testing of several innovative concepts, ultimately advancing what we think is a very novel and promising device, one that is fundamentally different from the edge-to-edge design of Abbott's MitraClip. The device is intended to augment the posterior leaflet of the native mitral valve, reestablishing valve coaptation and eliminating regurgitation. The device consists of a self-expanding stent that anchors in the left atrium and a baffle that fills the regurgitant aortas and creates a new coaptation surface for the native anterior leaflet. It is delivered via transfemoral access and is fully repositionable and recoverable during deployment. Most importantly, just like mitral valve replacement, Half Moon's device has the potential to fully eliminate MR. It also maintains the physiologic function of the native anterior leaflet, anchors without the challenge and risk of placing screws into cardiac tissue and preserves options for reintervention. As a result, we believe this highly differentiated transfemoral technology has the potential to address multiple mitral valve disease etiologies. I'm pleased to announce today that Half Moon recently received U.S. FDA approval of an early feasibility study in patients with severe symptomatic mitral regurgitation and expects to commence initial implants in the coming weeks. In summary, Medtronic has a strong pipeline in both transcatheter repair and replacement and we're building a portfolio with the potential to disrupt the current standards of care and position us to win in this market. Intrepid is leading the way in transcatheter replacement with positive transfemoral clinical experience in patients with both mitral and tricuspid valve disease. In addition, we believe that the redesign of the APOLLO pivotal trial will accelerate enrollment and commercial application. We are optimistic that Half Moon Medical's innovative device has the potential to disrupt the repair market with clinical evaluation of safety outcomes currently underway. Today, we have multiple active product development programs and 4 active clinical trials to transform care for the over 20 million patients who suffer from mitral and tricuspid valve disease. We are poised to create big new markets and in doing so, contribute to Medtronic's long-term growth acceleration. Back to you, Geoff.

Thanks again, Nina. Now I know the investment community has been wondering what we've been working on in the transcatheter mitral repair space. We've kept Half Moon Medical under wraps for the past 3 years. And it's great to finally share with you this differentiated technology that has so much potential. And we look forward to Half Moon commencing their initial implants in the coming weeks. Another market where we have disruptive technology under development is in GI cancer detection, prevention and treatment. Specifically, you're going to hear today about our plans to disrupt the detection and screening of colon cancer. To tell you more, here's Gio Di Napoli, President of Gastrointestinal.

At Medtronic, we created a business out of disrupting the status quo in the detection, prevention and treatment of gastrointestinal cancers and chronic diseases. We have done this by commercializing transformational technologies that improve patient management and standards of care while increasing access to our innovation across the globe. But we are not done. The need is too great. And there is a long runway of opportunity. GI cancers and chronic diseases are very common. 1 in 4 U.S. adults will be impacted by a GI disease in their lifetime. It's a market that is growing at 9% globally per year, with unmet and emerging needs. One area where we focus on is colon cancer. While colon cancer is the second deadliest cancer worldwide, it is the most preventable, yet least prevented cancer. For example, 1 in 20 U.S. adults will be diagnosed with this disease in their lifetime. But what's encouraging is that 90% of patients beat it when it's caught early. We, at Medtronic, can and must make a difference. We see an opportunity to significantly disrupt this market by taking the standards of care to a whole new level with a strong commitment to tackle colon cancer, enhancing screening capabilities, increasing patient compliance and improving treatment. And in doing so, we will dramatically grow the size of our GI business over the coming years. To radically improve patients' outcomes, colon cancer must be detected early, ideally, before it's even cancer so it can be treated early. Current screening practices are suboptimal. But we are setting out to change that. There are more than 10 million screening colonoscopies performed in the U.S. per year, in doctor offices, hospitals, clinics or endoscopy centers, to find and remove precancerous polyps. Colonoscopy is the gold standard, a most common screening method, but it's not perfect. Performance and outcomes vary based on a physician's skill level. That's why we are disrupting the market with GI Genius, the first commercially available artificial intelligence device for finding colorectal polyps that physicians may miss. GI Genius is currently available in Europe. We submitted a De Novo application to FDA in September and expect to launch in the U.S. following grant of that application. GI Genius helps improve the accuracy of colonoscopies and reduce the number of undetected precancerous polyps. With leading AI technology, we are getting colonoscopy closer to perfect, reducing variability in patients' outcomes, but it's still not enough. Every year, there are 22 million people in the U.S. that should get screened, but don't. And with the recently updated American Cancer Society guidelines that dropped the age recommendation from 50 to 45 years old, millions more will need screening. So why aren't people getting screened? According to the American Cancer Society, the top 5 reasons people don't get screened for colon cancer are colonoscopies are considered painful or embarrassing. They are concerned about the cost. Getting a colonoscopy can be logistically complex. Patients don't appreciate the risk for colon cancer. And they wait to develop symptoms, which by then could be too late. There are other options beside colonoscopy, like radiology exams and fecal tests, but these options don't detect precancerous polyps and are often not enough to convince people to get screened. So there is a big opportunity for us to disrupt this market with technology. We are out to improve patient compliance and bring colon screening into the future and into your home by creating PillCam Genius currently in development. We are taking advances in cloud technology and artificial intelligence and implementing them into our PillCam device. The aim is to create the only device that can see, size and localize precancerous lesions. While we bring this cutting-edge technology, we also need cutting-edge solutions to deliver this technology to our patients. I am excited to announce that we are partnering with Amazon, leveraging their delivery network, customer reach and cloud-based technologies to bring PillCam Genius to the market. This is how it will work. In the future, our PillCam Genius will be delivered to your door. You will put on a sensor and swallow a high-tech camera, the size of a multivitamin, then go about your day. Meanwhile, the pill-size camera will analyze what exists in your GI tract using artificial intelligence. Your doctor will get a notification that your screening is complete. He or she will then access the information, confirm the results of the AI analysis and send your diagnosis to an app on your phone. If nothing was found, you are done. If there is something that needs further investigation or removal, you will schedule a colonoscopy as early as the same day. We intend to start our pivotal trial in FY '22 and to submit PillCam Genius for CE Mark and for FDA clearance in late FY '23. And for those millions of patients who avoided screening until now, we believe we can reach them where they are, using social and digital channels to raise awareness of colon cancer and our convenient at-home screening option. So we have talked about revolutionizing colonoscopy with GI Genius. And we have talked about increasing patients' willingness to get screened with PillCam Genius. Now what about improving treatment? Once a lesion has been identified, it needs to be removed. Patients and clinicians face the choice between a minimally invasive endoscopic procedure that may not remove all precancerous tissue or a more invasive surgical procedure that could remove more than it needs to. They both deserve a better option. Endoscopic submucosal dissection or ESD is a proven procedure to completely remove lesions, but it's not widely adopted. It's technically challenging to perform, even for the most experienced clinicians, so many don't. This is why we are simplifying ESD with ProdiGI, an innovative endoscopic resection platform intending to help clinicians more easily remove these lesions. Our technology is designed to enable clinicians to perform ESD therapy with more control and fewer tools. We launched this device in the U.S. in July, and we expect CE Mark approval in the next few weeks. To conclude, we are disrupting the status quo by improving screening compliance, detection during screening colonoscopies and the removal of lesions. Last fiscal year, our GI business was approximately $400 million, growing in the high single-digit pre-COVID. With these 3 solutions, GI Genius, PillCam Genius and ProdiGI and a deep therapy innovation pipeline, we expect to dramatically grow our GI business over the coming years and in doing so, transform the current standard of care. Back to you, Geoff.

Okay, Gio. Thank you. Gio talked about our partnership with Amazon. Creative partnership like this is something I'm encouraging across our businesses. With the development of Pillcam Genius, we're combining our cutting-edge technology with Amazon's delivery network, customer reach and cloud-based technologies to accelerate adoption much faster. And in doing so, we create a new opportunity that can dramatically grow our GI business. So to conclude this section, we're going back to Cardiac Rhythm, the roots of our company, where we're developing 2 disruptive technologies. The first is Micra, our leadless pacemaker, where we have 2 models in the market now, with 2 more in the pipeline. Micra has been a real winner for us. And we expect it to continue to expand in the market. And we plan to follow that with our Extravascular ICD, which is poised to disrupt the ICD market. But I'll let Mike Marinaro give you the details.

Thank you, Geoff. Hello, again. Earlier today, I explained our efforts to transform our traditional product portfolio and extend our leadership in the market. As we discussed, these capabilities are driving the growth of our business. We have demonstrated our strong competency in the CRM business to envision and create new therapies and markets. Now I'm excited to share with you how we are disrupting our core therapies and creating new market segments to drive further growth with our Micra leadless pacing platform and our innovative, investigational extravascular defibrillator, EV-ICD. Since its initial launch in 2016, more than 70,000 patients globally have benefited from Micra. Our single-chamber pacing business has seen growth of more than 45% and unprecedented market share gains, and we remain the only company with approved leadless pacing technology in the market. With a full Micra portfolio, we believe the leadless pacing segment will be a $2 billion market, growing almost 25% annually over the next 10 years. Today, due to our advances in microelectronics, we will share how we will make leadless pacing possible for all pacemaker patients, with the recent approval of Micra AV and a preview of our investigational next-generation Micra Atrial. I'm pleased to have our Chief Medical Officer for CRM, Dr. Rob Kowal, share his thoughts about the Micra portfolio and the progress we are making in developing a complete offering of leadless pacemaker options. Before joining Medtronic, Dr. Kowal was an electrophysiologist, with extensive experience in planning Micra. Rob?

Thank you, Mike, for having me here today. It's my pleasure to talk about how Medtronic has continued to reinvent the pacemaker for the benefit of patients. For 60 years, pacing required placing leads or thin wires inside the heart and connecting them to a separate generator implanted in the chest wall. With Micra, we've compressed the pacemaker to the size of a vitamin, remove the leads and made it self-contained completely inside the heart. Our vision for a full portfolio of leadless pacing options includes 3 versions of Micra, Micra VR, Micra AV and Micra AR, each with distinct capabilities. Let's start with Micra VR, our first Micra device which received CE Mark and U.S. FDA approval in 2016. Micra VR is a single-chamber device that senses events in one chamber in the ventricle and paces the ventricle as needed. About 15% of patients need this type of pacing. Clinical studies have shown that the leadless design of Micra results in 63% fewer major complications for patients compared to traditional pacemakers. Further, there's no chest scar or device bump. So patients with Micra live a life without the daily reminder of their heart condition that they have with the traditional pacemaker. These benefits for patients have driven the strong market share and global growth of Micra VR. Our second addition of Micra, Micra AV, was launched earlier this calendar year, expanding on the capabilities of Micra VR. It has the same size, shape and implant location as Micra VR. But Micra AV can sense 2 chambers from its location in the ventricle, not just one. It uses a completely novel approach to detecting cardiac movement in the atrium, the upper chamber of the heart. The resulting atrioventricular synchronous pacing is designed to make patients with AV block feel better, have fewer complications and have increased blood flow with each heartbeat. With the combination of Micra VR and AV, leadless pacing is now an option for about 50% of all patients who require a pacemaker. We'll now hear from [ Stephen ], a patient who will share his experience with Micra VR. [Presentation]

Now that you've learned about Micra VR and AV, I'm excited to update you on our plans to extend the benefits of Micra to all types of pacemaker patients. To complete the portfolio, we're developing a third version of Micra, Micra AR, that can reside in the atrium, the upper chamber of the heart, and offer pacing to those with sinus node dysfunction. Currently in early stages, Micra AR requires a different delivery approach and a unique way to fixate the device into the atrial chamber. We'll then be able to combine the modular functionality of Micra AV and Micra AR to deliver dual-chamber or DDD pacing to those patients who need it. We'll continue to update you as we make progress with Micra AR and our goal of creating a leadless option for all patients who need a pacemaker.

Thanks, Rob. Next, we will discuss our work to disrupt the multibillion-dollar defibrillator market. The extravascular market segment of this market is a slow-growth niche segment estimated at $300 million. Today, this segment has only one product, Boston Scientific's S-ICD System. With the future addition of our differentiated EV-ICD platform, we believe we can dramatically accelerate the extravascular market to double-digit growth such that it approaches $1 billion in the next decade. Dr. Alan Cheng, Vice President of Therapy Development and Clinical Research for Cardiac Rhythm Management, will introduce you to the future of defibrillation, the EV-ICD.

Thanks, Mike. Traditional ICDs involve implanting a device below the collar bone with a lead placed through the vein and directly in the heart. While these transvenous ICDs are very effective in reducing mortality among individuals at risk for sudden death, there are drawbacks with having leads inside the heart in some patients. The Medtronic EV-ICD is our future solution to delivering the lifesaving benefits of a traditional ICD minus these drawbacks. Our goal with the investigational EV-ICD is to be the first and only ICD that uses a lead placed outside the heart in the extravascular space under the patient's sternum. By placing a lead in this location, the EV-ICD device has the potential to more efficiently treat life-threatening arrhythmias, while at the same time, has the same size and battery longevity of a current transvenous ICD system. This means that our device will be significantly smaller in size and have a substantially longer battery life than the current Boston Scientific S-ICD. But being smaller and having a longer battery life are not the only features the EV-ICD will have over the S-ICD. It will also be able to provide brady backup pacing and antitachycardia pacing, or ATP, for short. Numerous studies have shown that ATP is extremely important because it can stop deadly arrhythmias with painless pacing therapy and thereby potentially saving a life without the trauma often associated with the shock. This is a huge improvement over the S-ICD, which can only deliver painful high-voltage shocks. These are just a few reasons why we are excited about EV-ICD and why we believe this system is poised to further disrupt the ICD market. We have taken this concept from the bench and have already completed 3 clinical studies and are currently enrolling in our global pivotal trial to support market entry in the first half of calendar year 2022 in Europe and the first half of calendar year 2023 in the U.S. There's a great deal of excitement about this innovation within the EP community and what it can mean for our patients. We look forward to bringing the EV-ICD to market in the near future, thereby disrupting the implantable defibrillator market and transforming our business to drive growth. Back to you, Mike.

Thanks, Alan. As you heard from Drs. Kowal and Cheng and in my opening comments, we are aggressively disrupting our core therapies and creating new markets to drive further growth. We are confident in our ability to expand markets by delivering the full vision of Micra and the EV-ICD program to serve more patients globally and continue the strong acceleration of the CRM business. In fact, our ability to envision and then execute market disruption is a core competency in our business. We have demonstrated this capability many times in our history. For example, we created the implantable diagnostics market, we created a pacemaker market, and we are disrupting it with leadless pacing. We created the entire category of digital and remote patient management, and now, during COVID-19, we've applied our comprehensive suite of remote capabilities to reduce the exposure of patients and doctors. It's a really exciting time in our CRM business. Continued and sustainable growth is ahead. Thank you.

Thanks, Mike. Very exciting. The leadless pacing and Extravascular ICD markets are expected to be $3 billion by the end of the decade, representing strong growth opportunities for Medtronic. And this is what I mean when I say Medtronic creates markets and disrupts markets, big markets over and over again. I'm sure the analysts have some questions about all these big market opportunities. So let's send it upstairs to Ryan for a Q&A session. Ryan?

Great. Thanks, Geoff. We're now going to take questions on the 7 market opportunities that we just featured in the past segment, which was how Medtronic is creating and disrupting big markets. To answer your questions, I'm joined by Dr. Laura Mauri, our SVP and Chief Clinical and Regulatory Officer. Some of you may already know Laura, who joined Medtronic about 2 years ago and just became a member of our Executive Committee. Prior to Medtronic, Laura was a practicing interventional cardiologist at the Brigham and Women's Hospital. She was a professor at Harvard Medical School and was Chief Scientific Adviser for the Harvard Clinical Research Institute. We're pleased to have Laura here at Medtronic. Also joining Laura today, we have Mike Coyle and Bob White back with us on this Q&A panel. [Operator Instructions] So with that, we'll go to the first question. Let's go to Larry Biegelsen. Larry, are you there?

I am. Can you hear me okay?

We can. Yes.

Great. All right. One on the surgical robotic program and one on renal denervation. Starting with the surgical robotic program. The main advantage Medtronic seemed to have was lower per procedure cost versus Intuitive Surgical, but Intuitive is lowering their instrument cost. Do you believe that neutralizes your advantage? And what other tangible advantages do you bring to the table? And I have one follow-up.

Yes. Thanks, Larry. It's nice to hear from you. Actually, we have several advantages. If you think about surgical robotics, it's the most exciting market in med tech, and we're poised to enter it and disrupt it. And if you think about it, the big limitation to surgical robotics, as you mentioned, has been cost, but it's also been utilization with robots used less than 2 times per day. And if you think about the Medtronic value proposition here, we've got a breakthrough modular design. We have best-in-class instrumentation, which, by the way, is compatible with our leading surgical franchise instrumentation, we have outstanding visualization, and so you've got a platform that is modular to be able to be deployed across a number of operating rooms. And in fact, I think about this as we begin the global launch sequence that Megan just talked about, we're also initiating a complete pipeline across these 4 technology vectors, Larry, that I've talked to you about in the past, which are the robotic system, instrumentation, visualization and data and analytics. So actually, we have a lot of advantages across all of those. And what I saw Gary and his team did by reducing instrument pricing, that actually validates what we've been talking about, which is cost is a problem. So it's a nice step in the right direction, but we feel really confident about our value proposition and where we're going.

And on renal denervation, how are you guys feeling about isolated systolic hypertension being on label and reimbursed upon approval in the U.S. given that those patients account for about half of all elderly hypertensives were excluded from the trials. It seems -- is that why you're doing the AFFIRM trial? My impression from today is that there might have been -- you might see that as more of a future opportunity, not something at the beginning.

Maybe, Laura, you might want to weigh in on that.

Sure. I mean I think we can take a step back and just say that we have a sequence of trials, and it's just an ongoing cadence of, first, you saw OFF-MED clearly demonstrate the effectiveness of renal denervation. And next, now we'll see with ON MED whether that's still -- we still see that effectiveness in the setting of medications. So I think as we look ahead to continuing to expand, we'll look at other areas to enrich the data. We have a lot of data from the global simplicity registry as you've seen over 3 years of follow-up in thousands of patients who have been treated that show this ongoing effectiveness. And from that, we have subgroup analyses, and we can certainly refer you to those to look at the isolated systolic hypertension data set.

And just to be clear, Larry, the numbers we gave you in terms of expected market size for the FY '26 and FY '30 don't reflect penetration into that group of patients. So we have the opportunity as we obviously demonstrate the efficacy and safety of the technology in the targeted patient population from the -- from our Symplicity trials to expand into new indications for use and new patient populations to follow this work.

Next, let's go to the line of Danielle Antalffy. Danielle, are you there?

Can you hear me okay?

We can, Danielle.

Okay. Great. Just a quick question on the mitral piece of the business. I guess just curious how you guys are thinking. I know you talked about growing to over $3 billion. But this is obviously a very different market than the aortic stenosis market and appreciate your talking about a toolbox here. How do you think market development here is going to play out? And kind of thinking about things like appropriate centers initially and how quickly we can get to that $3 billion, it's obviously a much more prevalent disease than aortic stenosis, so potentially much larger than that. But how do we think about the rollout? And does TAVR serve as a decent proxy there? Or is that -- is it going to take much longer?

Well, thanks, Danielle, for the question. Maybe I'll weigh in. Basically, TAVR is a bit of a different market in the sense of the sort of heart outcomes that were able to be generated early on in the trial relative to mortality and whatnot. So this is a more complicated space in terms of just the difficulty of the procedure and the different underlying etiologies of the disease. And this is why we say a toolbox is really going to be required. So at this stage, it really comes down to actually proving who are the right patients and what kind of outcomes are we getting. And obviously, we now have decent patient volumes from the work that's been done in the edge-to-edge segment that tell us both the strengths and limitations of that technology in terms of treatment of these patients. And obviously, it's a procedure that is relatively easier to do, but also has a lot of residual MR, and success rates vary even in the clinical work that's been done. So obviously, our approach has been to see if we can find some more robust solutions that will give us better longer-term outcomes in terms of residual MR and whatnot, which is why we've really focused in on both the replacement market with the APOLLO trial and now the work that we're talking about with Half Moon on the leaflet augmentation approach to mitral. And I would just say, I think the market development and what's going to take place with the edge-to-edge work is a little easier to project. But once we see competitive technologies come out that have better sort of results in residual MR, we can see a pretty big switch to other technologies that are just getting better outcomes. And I would ask Laura, if do you have any perspective on that as well.

Yes. When I think about where we are right now, as Mike alluded to, edge-to-edge is a therapy that leaves patients with significant residual mitral regurgitation. And the 2 approaches of Intrepid and the Half Moon really are designed to be able to eliminate mitral regurgitation. Those are the objectives of both of those programs. And specifically, with Half Moon, the ability to buttress the posterior leaflet is really novel and also has a transfemoral approach. So it's very exciting. So I think, back to the original question that you asked about, how will the cadence be of progressing into the market, I think it's going to be a series of technologies with better efficacy and then the clinical evidence to support that that's -- that, in fact, translates to benefits that patients will see and the utilization by physicians and the procedures. And this is a unique -- it is a unique space, where there's a variety of different etiologies as well as outcomes for mitral regurgitation, and you have a different set of providers involved as well, with more of the heart failure specialists involved. So it's not the same as TAVR. But I think the lessons that we have from going into spaces, where there are collaborative groups that exist across different physician societies, I think will be useful as we go through this new phase.

If I could just ask one quick follow-up there. I think a few years ago, maybe even just last year, I can't recall, at TCT, you guys were still -- maybe it was 2 or 3 years ago, actually, you guys were still thinking that mitral valve replacement was the answer, it was all about eliminating mitral regurge. And I guess I'm just trying to get a sense of, with Half Moon, have you -- it sounds like maybe you've changed your view there. Have you seen something in the early stages with Intrepid that made you go the route of having some sort of repair offering, or am I reading too much into that?

Well, thanks, Danielle. I actually think we are a lot more encouraged with the specific design for the leaflet augmentation approach that Half Moon has developed in conjunction with our program here that gives us more enthusiasm about the potential to address the sort of residual MR question with repair. That being said, we know, based on large numbers of patients that have been done, that we do get that very strong outcome -- efficacious outcome from replacement. And obviously, we continue now to move into transfemoral delivery of that replacement option in the Intrepid program and we see paths to actually create even smaller diameter approaches for delivery of that valve down the road. So like I said, our approach is to take a toolbox approach, and the fact is we've not done a human yet with the Half Moon technology. So we see this as an opportunity. It is going to be a huge multibillion-dollar opportunity, and we see more than just one shot on goal to be able to be successful here.

[Operator Instructions] Next, let's go to the line of Raj Denhoy. Raj, are you there?

Yes. I'm here. Can you guys hear me okay?

We can.

Great. Great. One on Pillcam and then one on renal denervation. So on the Pillcam, as you described it sort of expanding into this more screening mode for that technology, are there any changes with the technology with valve preparation or anything that needs to happen for that device to move to more of a screening tool? And then what does the trial look like to move to that sort of indication?

Yes. Thanks, Raj. It's a great question. And if you step back and look at our GI business, this business is a real tiger. If you think about it, they have staked out leadership positions in high-growth markets by delivering disruptive technology in, as you suggest, screening, diagnosis and therapy. And the way they've done this has been fantastic. And if you look at PillCam itself, this is really bringing the tech into med tech. And if you think about the AI algorithms that are evolved, and Gio talked a little bit about this, is the ability to swallow a vitamin-sized pill, have a disposable patch, have that go on up to the cloud, transmit it back down to your doctor's device and figure out whether or not you need a therapeutic colonoscopy, is actually pretty exciting. And I'm really excited what this team is doing here. And we're planning for a pivotal trial here to do that, and it's got to be multi-center and it's really going to look at the efficacy of the detection of these precancerous polyps. And as Gio mentioned, which I think is tremendously important to remember, is there are 10 million colonoscopies done every year in the U.S. and there are 22 million Americans today who don't get their screening colonoscopy. And the new guidelines have just added another 20 million Americans to that as it came down to age 45. So we're really excited about the opportunity this is going to bring us. And as you may have seen on Gio's video is GI Genius, which is really bringing AI to GI is also helping with precancerous polyp detection, right? So now, we've just done a randomized prospective study in Europe that showed a 16% better detection rate of precancerous polyps using GI Genius. So you've got AI and GI Genius. You've got artificial intelligence and Pillcam Genius. And we're just really excited about what the future is going to bring there, Raj.

Okay. Thanks, Raj. Next, let's go to the line of Jayson Bedford. Jayson, are you there?

I am. Can you hear me, Ryan?

We can. Yes.

Sorry, I was just cringing at my picture on the screen there. So I wanted to just revisit the growth in Cardiac Ablation Solutions. I appreciate the pipeline, but I got the sense from the discussion back in July that you were looking for high single-digit growth in this segment, which I think is a little slower than market. But today, you alluded to some share gains. And so maybe you can just address this dynamic specifically, your anticipated growth over the next couple of years versus the market?

Sure. Thanks for the question, Jayson. And certainly, heading into COVID, we were seeing high single-digit growth, which is -- was a bit below the overall market growth, which, basically, we feel like was a shift in the types of patients who were having ablation done. We're seeing a greater sort of mix shift to persistent atrial fibrillation cases from paroxysmal, and that requires more extensive ablation beyond simply the pulmonary vein isolation. And while some physicians will do pulmonary vein isolation with cryo and then pull out other devices in order to make additional lesions and sometimes use the cryo balloon itself to do additional ablations, the mix tends to then go to focal ablation technologies because they're able to be used in both cases, they're able to do point-by-point ablation around the pulmonary veins as well as then be used for focal ablation at other parts of the heart. And as that mix change obviously was occurring, we were seeing some slowing relative to the overall market growth. So high single digits is still obviously robust. One thing we are seeing in the post-COVID environment as we see recovery of atrial fibrillation cases is that accounts really value the speed and simplicity of being able to do a pulmonary vein isolation with cryoablation as opposed to the more time-consuming and mapping and point-by-point ablation that goes with a more pure case of PAF. And so we've actually seen a rebound in terms of some nice growth associated with that segment, which hopefully will sustain as we move through the COVID environment. But as Rebecca outlined, our objective here is not to be simply a pulmonary vein isolation company. And obviously, the move to the modification of the name of the business to Cardiac Ablation Solutions from AF Solutions was really to highlight that, that, in fact, is a 3-tranche strategy of 3 core technologies, cryoablation for pulmonary vein isolation, which we have now created and continue to advance with new indications for use, and in the persistent application and then first-line therapy that Rebecca outlined. But now the move to a focal platform that is differentiated with the DiamondTemp technology, which, basically, unlike all of the products for focal ablation today that are in the market focused on sort of the use of traditional RF with 4 sensing catheters, their surrogates for contact and therapeutic outcomes, we are now back to a true closed-loop temperature-controlled platform, taking advantage of both the heat sync associated with the diamond, the industrial diamond at the tip of the catheter, but also the high-fidelity electronics at the tip which allow us to basically do a true closed-loop controlled ablation using temperature as the actual measurement instead of a surrogate. And as was mentioned by Dr. Burman, I mean, we are actually seeing some very nice improvement in terms of the speed of the procedure, but maybe even more importantly, the total amount of RF energy that's being delivered. And while we are pursuing noninferiority designs for this product, we basically believe that, that less RF application can translate into safety advantages that we hope to see in sort of subsequent trial work. And then, of course, the longer-term opportunity here is to completely disrupt the market, moving into the post-field ablation or our irreversible exploration area, where we have the clear lead in terms of published feasibility work or presented feasibility work and the initial breakthrough designation and IDE approval around the pivotal trial. So while there's a lot of work yet to do there in terms of demonstration not only of sustained safety but sustained efficacy and optimizing how that energy is delivered, we really feel like we have 3 important core growth vectors for what is one of the most attractive businesses in the cardiovascular segment.

Let's next go to the line of Matt Taylor. Matt, are you there?

I am here. Can you hear me okay, Ryan?

We can. Yes.

Super. Okay. I wanted to ask a question that spans across a few different categories. I noticed that a number of the key products that you're talking about in the pipeline have a breakthrough designation. And we all know that it's been this proposal from CMS that you highlighted, could be really interesting to cover those devices right away. And so I was wondering if, a, you had incorporated any benefit from that in your forecast. Can you talk about what that could mean? And what are the levels of reimbursement that could be set by a process like that? If you have any understanding of that, it would be helpful to get some context.

Well, maybe we could start with -- in the context of renal denervation. Obviously, one of the concerns we've had about the market development activity for renal denervation for -- since the beginning of the program was the establishment of reimbursement and how historically that had trailed the approval, the FDA approval, of the technology. So it actually is quite encouraging and I think quite logical that CMS is now basically looking to link the designation of a breakthrough device designation to more rapid availability of reimbursement. And so the proposed rule would basically say you get 4 years of coverage associated with that technology when it's approved, if it's approved under a breakthrough designation. So if that sustains, then obviously, it now is a great advantage in terms of accelerating adoption within the United States, but I think provides a very powerful message to private payers as well as to global reimbursement agencies around the attractiveness of this technology. But I would say though that the studies that we have done to date make us very enthusiastic about the cost effectiveness of renal denervation, independent of that sort of proposed rule in the sense that as we have done the math, we basically see that if you use that sort of $100,000 per quality adjusted life year hurdle, that we could see a benefit of the smallest 4 millimeters of mercury reduction as being cost-effective under that criteria. And if you look at the ON MED study, the pilot study that we did that showed closer to a sort of 9.5 millimeter reduction, that turns out to be like a $30,000 per quality adjusted life year number. So we think these technologies are going to stand on their own relative to reimbursement and be very compelling cost effectiveness stories, even independent of the breakthrough device designation. And it's really a case-by-case discussion on that topic, but obviously, the availability of breakthrough designation, whether it's for our post field ablation work or any of the other technologies that we have meeting that category, it is certainly helpful to get a run out of the gate, where there's coverage from CMS, to allow us to get to the ends of patients that basically demonstrate the cost effectiveness and not just safety and efficacy of the technology.

Mike, and I would just add, speaking more broadly about the collaboration with the FDA, they've just been fantastic. If you think about how the FDA stepped up during the pandemic with emergency use authorization, the EUA, was fantastic. They've got great collaboration across our portfolio. So just a real shout out to the FDA and the collaboration. And Laura and her team have been so instrumental with getting us a position and audience. So I just really compliment the work that our teams have continued to do with competent authorities around the world, but particularly, the FDA, it's been really meaningful.

Yes, I agree. It's been striking the level of discussion and responsiveness when you think about everything they've been working on. They've been very helpful with making sure that they understand how our clinical trials are progressing and that we're staying on track and resuming enrollment in our key programs and really up to speed across the board, essentially in all our major programs.

If I could just ask one related follow-up since Ardian is very related to this breakthrough designation. Could you talk about what you're assuming? You mentioned the 1% penetration to get to those targets. What are you assuming for reimbursement and pricing? If you could give us any ballparks on that?

Yes. So just some of the basics of the model. We obviously have a lot of experience with new therapies being brought into the market and then sort of mapping how they go through what we call their patient access acceleration hurdles and move to market development. And so we've based our modeling here on past experience, how the ICD market grew, how the TAVR market grew, what's going on with WATCHMAN. These are all areas where we think our models have driven off incidence pools because that's where we tend to see adoption take place. We basically view this as a procedure that probably costs in the range of $14,000, $15,000. Half of which is the device. And so we view that as sort of fixed into our modeling. And then it comes down to your patient sort of penetration. And we are obviously assuming that we would get reimbursement that's commensurate with that level of pricing. And then it comes down to who are the patients who get it. And obviously, even though our patient pool from just looking at the ON MED and OFF-MED pivotal trials is fairly broad in terms of that 140-millimeter-plus level of systolic hypertension as well as having and typically been targeted at 3 drugs that they failed, when we get out to the 2030 time frame, we're only talking about penetrating about 10% of the 153-plus drug group that Jason mentioned in not only his U.S. references, but his references to China. So it's a relatively low adoption, even a decade out from here. But we think that has the potential to be accelerated as we generate more data and in more patient pools. So we think that's an appropriate sort of modeling, as we've seen from other breakthrough sort of new markets. But obviously, there are a lot of unknowns that still have to be worked out.

Let's next go to the line of Pito Chickering. Pito, are you there?

Can you guys still hear me?

We can. Yes.

Great. Mike, like I want to dig a little bit on renal denervation. And I acknowledge it's pretty early, but it's a pretty big opportunity for you guys. Can you give us some color on what your strategy is to develop the market for renal denervation? Do you plan to start marketing, investing in sales channels ahead of 2020? And could this be a margin compression event like ahead of the launch as you prep for the launch?

Well, obviously, the work that we're doing that sort of Laura and I have been talking about here in terms of just the clinical trial execution and the work with the payers around the world is obviously going on right now. We think the ON MED data is crucial to this development of the market, in that most regulatory and reimbursement authorities around the world believe that, that will be critical to -- that it will be used with medications. And so it has to be shown to be independently contributing. So obviously, given that we've completed the pilot trial there and continue to execute the trial, as Laura mentioned, we are basically -- that's sort of the gating item for the big next step of activity. But that next step of activity is what Jason was referring to in his commentary, where, basically, we need to establish a hub-and-spoke kind of model, where the interventionalist is linked to the physicians, hypertension specialists, the cardiologists who are seeing the large numbers of hypertension patients, and that the patients themselves need to be engaged. And one of the learnings from the entire experience here on the ON MED and OFF-MED Symplicity -- HTN Symplicity work has been how engaged patients really are when they are either not in control of their hypertension or are not tolerating the drug side effects well. And Jason referenced that a lot of the trial recruitment that we had done has really been around direct-to-consumer awareness of the availability of such a therapy. And then providing apps for them to actually be screened for participation in the trial. And as you can imagine, this is a difficult trial because of all the measurements that we are doing, the urinalysis around drug control as well as the ambulatory blood pressure measurement and the checkup. So a lot of patients opt out of the trial. But we have now a database of 100,000 patients worldwide who have reached out to be screened on this technology. And so from our perspective, we have a really good running start in terms of being able to -- once we have approvals, be able to identify patients who are going to benefit based on the labeling and the evidence that we generate. So we see a very clear path for market development on multiple fronts, and we're very excited about that as maybe a little different way than we've done historically in developing new markets. And I don't know if, Laura, you have anything you would add to that.

Yes. No, I think it's really -- I mean I think when we think about hypertension, yes, we know that there are hypertension specialists in tertiary care centers who have real challenges with managing patients on multiple medications. But it's true. What we learned in the trials is that there's a tremendous demand directly from patients for alternatives to medications or better ways to manage their multiple medications. And so I think it's very exciting. I think it's -- and it's part of the broader Medtronic interest in how do we directly communicate with patients.

Great. Then a quick follow-up for you, Mike. New product launches are the lifeblood to Medtronic and the key to accelerating revenues. Can you walk us through how COVID has changed the near-term product launches, specifically in the inpatient settings? And how would you think about the adoption of these products over the next 12 months versus a pre-COVID world?

Well, I think the approach to basically training and education is a little more challenged in this environment than we've seen, obviously, in terms of we would typically force something, like Micra obviously would bring physicians in for formalized training and then do cases with them. And so both the ability to sort of bring that in as well as to actually then have people participate in case training is more challenged here. Fortunately, for us, because the implant techniques around Micra AV, for example, are the same as for Micra, we've been able to do a lot of that training, just really educating them on the differences between the accelerometer detection of the atrial contraction and not have to do a lot of hands-on sort of clinical training. And so we've been in a window where we've been rather fortunate, other than for EV-ICD, where there is an implant technique there that it took us a little while to basically get physicians comfortable with coming in for training and to develop tools that we can do without having -- actually have them come in to a lab or cadaver animal lab to do the work. So I think we're learning. And actually, not only are we learning, I think we're actually learning this could be pretty good from the standpoint that the ability to do directed education as we saw at ACC last year, for example, is actually, I think, going to turn out to be a much more efficient tool for creating common messaging that's distinct and consistently applied to the customer base versus relying on individual field sales reps and field sales personnel to deliver that consistent messaging. And so by providing these tools now online, we not only can deliver them more efficiently, but I think we can also check that they have been delivered. And that, I think, is going to help us with the adoption of virtually all the technologies that we've just reviewed this afternoon.

Yes, Mike. And I would add, I think COVID -- a lot of these learnings have been very durable, right? If you think about what we've been able to accomplish, the thousands of surgeons and physicians we've been able to connect with, it has been outstanding how many we've been able to connect directly to. And we even installed a surgical robot all virtually, right, with teams, not even on sites, but directing the teams on-site virtually. So Pito, I just think you've got to really look at what COVID has taught us. And there's a bunch of lessons here that I actually think will accelerate the way we deal with physicians and surgeons and even our own internal teams going forward. So it's been a lot of positives coming out of this.

Just one example, Pito, I'd just like to point out is we talked about the use of this remote control feature within our Cardiac Rhythm devices. And literally, in the beginning of March, there were 0 accounts in the United States who were doing remote programming of devices. Now there are 270 accounts that are doing it on a regular basis. And when we talked a few years ago about MRI safe technology and the need to turn off MRI capability for a patient going into an MRI machine, we're all worried about the burden, the service burden that, that was going to create for our field. I can tell you, [ 30% ] of our remote programming activities have to do with the shutoff and turn on of MRI for scans. And we're now standardizing on that as an alternative to our reps actually showing up and doing that work, which means we're now being able to expand the productivity of our field sales organization beyond simply the appeal to the customers. So really durable learnings that are going to help us long term.

Yes. Mike, I think about the other example, which has just been so fantastic out of COVID, is when our ventilation team, working with an external partner, determine the ability to remotely control the ventilator outside the patient room, right? So not only did this reduce caregiver exposure to COVID, it also reduced the need for PPE. So you just see a lot of really great examples of innovation and creative thinking as a result of the COVID experience.

Thanks, Pito. Next, let's go to the line of Steve Lichtman. Steve, are you there?

I am, Ryan. Can you hear me okay?

We can, yes.

Great. Mike, on renal denervation, obviously, a very big market opportunity that could potentially benefit multiple players, but I did want to ask on your competitive lead here. During the initial simplicity clinical trials years ago, we saw a lot of other companies looking to come to market. What do you see different potentially this time around for you to continue a lead upon hopeful approval in the U.S.?

Well, thanks for the question, Steve. And obviously, it's a very different environment than it was when HTN-3 was being executed in that virtually all of our sort of major competitors who you all know we love had programs that they were executing sort of in parallel. And today, we can identify essentially 3 competitors in this space who are actually doing any kind of meaningful clinical work. And clinical work in this space is hard to execute. And we've seen a lot of challenges with even those competitors being able to execute the kind of trials that we are doing with the on-med and off-med work. So we believe we're going to have a multi-lead in here if we're able to get the approval here on the time frame that we're talking about, and we have a lot of confidence that we can get that approval, as Jason outlined it. Obviously, we continue to have some strong intellectual property from the original work that -- the acquisition that we had done in the space. We've continued to work on the evidence that we think will provide differentiation for our approach. We've learned a lot about this patient pool and what works and what doesn't and where we should go next. And so from our perspective, we think we are going to have, unlike what we expected then with rapid clinical trials being executed and coming out with multiple competitors, we think this is going to be a hard space to follow. And as Geoff has mentioned, we're going to be doubling down not just in the market development activities here but expanding our lead in the technology side. And Laura, I don't know if you have any comments here. You actually have a unique perspective having had visibility to a lot of the work done in the space by multiple competitors.

Yes. I mean as you said, it's a challenging space. But I think what we bring is just that multiyear commitment to the technology, to optimizing the procedure, to identifying where these patients are coming from and having more direct lines of communication. So I think it's a really strong body of evidence and a strong technology that we're bringing forward that should put us out in the lead for a good time.

It's probably just worth noting, we talked about sort of 3 core pieces of evidence for approval, right? One is the OFF MED, which you've already seen at ACC, then the ON MED, which we've talked about here, we expected to be available next year. But there's also the global simplicity registry that establishes safety for this, which is a multiyear, several thousand patient effort, right? And so just trying to replicate that with another core technology is going to -- time-consuming and difficult.

We'll go to the line of Amit Hazan. Amit?

Hey, can you hear me okay?

We can.

Great. I want to come back to robotics and just ask about the U.S. progress, in particular on the regulatory plan, if you're going for a specific or broader plan for approval. If you could just talk to -- confirm whether you're on a de novo pathway and what that means exactly from a clinical requirement standpoint? And if you can share with us which indication you're going for first, and how long it might take you to get a broader set of indications, that would be great. And just one quick follow-up after that.

Yes. Sure, Amit. Thanks a lot for the question. So as Megan may have highlighted in her talk just a few minutes ago, we're on track for our CE submission in the first quarter as well as for our IDE filing in the first quarter. And look, our conversations with the agency have been ongoing and continue to be very productive. I know that J&J delayed their program. I don't know if that was a result of something they learned new from the agency or not. But we are not filing for a PMA approach on this. And our discussions with the FDA between a 510(k) and a de novo are ongoing. And I would -- to the second part of your question is we absolutely do anticipate sequential approval of indications. I'm not going to go into the specifics in terms of which one, when. But again, as you can anticipate, Amit, our robot was absolutely designed as a general surgery robot. So colorectal, DINE, bariatric, you name it, it's going to cover those procedures. And every robot we place, even outside the U.S., will go towards that clinical registry that will build that body of evidence. So great collaboration. I think we're right on track, and you could expect to hear more.

Just as a quick kind of related follow-up. I think at last year's analyst event for the robot, you suggested FDA approval could happen by the second half of calendar '21. Just wondering if that's still a good timeline for us to expect for approval. I think that would have helped to explain the 100 to 150 basis points in contribution to your fiscal '22 that you're thinking about that you reiterated today. And so just trying to understand if that revenue buildup for the fiscal '22 year in particular has evolved at all in terms of how you're thinking, getting to that level of revenues in that year.

Yes. So thanks a lot. When we talked about -- 2 things in your question that you talked about was U.S. approval. That's going to start with our IDE submission, which we talked about in the first quarter of this year. And then as Megan talked about a few minutes ago, we reaffirmed our commitment to, if you think about the business, less than 50 basis points of growth in '21. We talked about 100 to 150 in '22 and then 200 to 250 in '23, and we absolutely remain on track with that. So we feel good about where we're at, and we're excited to come in and disrupt this marketplace. We think we're uniquely positioned to do so, given some -- not only the design of the system but the innovation we've got planned across those 4 vectors you've heard me talk about.

Great. Thanks, Amit. We're going to end there. We do have one more Q&A session coming up a little bit later on this afternoon, where you'll hear from our CEO, Geoff Martha; and CFO, Karen Parkhill. We're now going to take a 15-minute break. And when we come back, you'll hear from Karen, who will give our financial presentation. And again, during the break, we are going to be rolling some videos on Medtronic. So I hope you'll stay close to your screens and watch those and you'll find them informational and informative. So I'll see you back in about 15 minutes. Thanks, everyone. [Break][Presentation]

Hello, everyone. Thank you again for joining us today. I hope you have found the presentations and insight into our strategy helpful. As you've heard from the team throughout the day, we have a clear strategy to win, a robust pipeline and a deep bench of talent to drive strong performance. Today, I'll spend some time on the drivers of our growth acceleration and discuss the variety of ways we have been and will continue to fund this innovation. And of course, I will talk about the actions we are taking to drive productivity and close with our new financial outlook. Let's start with accelerating our revenue growth. We are confident in our ability to grow sustainably at or above WAMGR, our weighted average market growth rate. You've heard all of us say we strongly believe we have the industry's best and broadest pipeline, and we are very excited about our recent and upcoming launches as well as the products that will be coming over the next few years. In addition, our differentiated R&D, our go-to-market strategies, our continued focus in emerging markets and an increased cadence of tuck-in M&A will also drive our growth. And all of this is better enabled by the organizational actions you heard Geoff talk about that empower the operating units to become more nimble and more competitive, which will in turn unlock value. We're going on offense across all of our businesses. As you heard earlier today, Cardiac Rhythm and implantables with cobalt and chrome, Spine and Pain Stim, neuromodulation with Percept deep brain stimulation and surgical innovations are just a few of the exciting areas where we are poised to take share and accelerate our growth. You also heard earlier today how we are creating and disrupting big markets that has significant growth potential like our soft tissue robot, micro line of leadless pacemakers, EV-ICD, PillCam Genius, mitral repair and renal denervation. We believe these opportunities will further accelerate our growth. In addition, we are really honing our commercial execution. We are dedicating resources towards maximizing our important commercial product launches like our soft tissue robot, including building out new specialized teams to support training and optimize utilization. We also see significant runway for growth in emerging markets, where we're forming dedicated sales organizations that leverage the company's scale but move with the same agility as smaller local competitors. These markets, which make up about 16% of our revenue last year, have consistently grown in the double digits pre pandemic, and we expect this to continue over time. We are well positioned to accelerate our revenue growth and sustain it into the future, thanks to our strong pipeline of innovative products, ongoing investments in technology and R&D, emerging markets growth and our operating model changes. As a result, we are raising our annual organic revenue growth target to 5-plus percent from our previous objective of 4-plus percent. This 5 plus is reflective of what we can deliver over the long term. And in some years, our organic revenue growth could be higher, given the expected cadence and strength of our product launches. Going forward, we will continue to invest in our future by funding the development of new and disruptive therapies that identify unmet clinical needs and create new standards of care. We will do this in our P&L, on our balance sheet and with the help of partners. Prioritizing investment in innovation, where we see the best opportunities will position us for growth over the near and long term. We are actively managing and allocating capital through a strategic investment lens to drive greater discipline, focus and rigor around deployment to our operating units. And we use an active portfolio management framework, not only to review the balance across our investments, but also to enable transparent debate and discussion. This helps ensure we fund opportunities with the best and highest return. We're using many different vehicles to drive investment, including organic R&D, venture investment and tuck-in M&A. We're also partnering strategically with others like Blackstone and The Foundry, which I will talk about in a few minutes. With organic R&D, we are investing over $2.5 billion each year over the long range to ensure our pipeline remains full and that we continue to bring to market innovative and disruptive programs that produce better outcomes for patients. We have already boosted R&D spend in some businesses, like diabetes, and we plan to do more. While our pipeline has some very innovative technology, we recognize that invention of advanced therapies and technologies don't always come from within our walls. So we regularly assess external sources of innovation to enhance our competitive position and bolster our growth. In addition to our strong business development team, we have a seasoned venture investment team focused on ensuring we drive smart investments that supplement our portfolio and drive strong financial returns. That team oversees our minority investments and serves to develop and facilitate potential future tuck-ins in a capital-efficient way. Many of these investments come with Board seats and acquisition rights, and they also give us an opportunity to stay close to early technology developments across med tech. Today, our portfolio includes well over 40 companies and approximately $500 million of invested capital. Most of the companies in our portfolio are early stage, where clinical, regulatory and reimbursement risks remain. And we bring our global expertise to those portfolio companies to solve these challenges and help accelerate the achievement of milestones. A recent example of this is Stimgenics. We originally invested in this company in 2017 when they still needed to complete additional clinical testing on their novel waveform for DTM spinal cord stimulation. Then last January, one Stimgenics study showed superiority for DTM and back pain relief. We exercised our acquisition option and quickly launched DTM with our Intellis platform. Today, Intellis and DTM are driving share gains for us in the Pain Stim market. Stimgenics represents one of a string of tuck-in acquisitions that we've executed since the beginning of the calendar year as we've increased our cadence of M&A. In addition to Stimgenics, we've announced a series of deals. Digital surgery has AI backed by variability across procedures. Laser Associated Sciences is a noninvasive system for monitoring real-time blood flow and peripheral vascular surgeries. Medicrea uses AI for preoperative science surgery planning to create custom implants. Companion Medical has a smart pen technology, which gives diabetic MDI patients another option beyond the pump. And finally, Avenu, which we announced 2 weeks ago. Avenu is the only single catheter endovascular method for AV fistula creation. The combined consideration for these acquisitions is over $1.6 billion. They each represent future growth accelerators, and they have no material near-term dilution. Our disciplined and rigorous approach to M&A means that we grow what we buy. In other words, we find ways to efficiently purchase before an asset has reached maturity where valuations are high. In addition to making minority investments, we often enter into structured deals that pay upon achievement of milestones, and we look for assets that have synergies with our existing businesses from a strategic, financial and operational lens. In terms of criteria, we look for assets that will increase our WAMGR, differentiate our portfolio and accelerate our time to market or supplement an existing program. Equally as important is being clear on the benefit that Medtronic brings to a business. That might be our global footprint; our clinical regulatory capabilities; our emerging markets expertise, both commercial and regulatory; our manufacturing capabilities or economies of scale; and our broad commercial relationships or a much larger sales force. In terms of size, we're focused on tuck-in acquisitions. And this tends to mean that total consideration ranges from the tens of millions up to the low billions. We are also using third-party funding to leverage our own R&D investment and accelerate growth. In June, we announced a partnership with Blackstone Life Sciences to expand development of future diabetes technologies across 4 specific programs. Blackstone's $337 million funding dramatically accelerates the time lines for those programs without increased current expense during development. And upon commercialization, we will pay a royalty to Blackstone for a certain period of time when our higher revenue can easily cover the added expense and be accretive to margins. While this type of collaboration is often seen in pharma and biotech, it's novel to med tech, and it's a structure we're looking to pursue in other areas of our business. It also reflects our creative and thoughtful approach to investment. In fact, the expected return from these types of transactions is better than the double-digit returns we typically expect from tuck-in M&A. And as you heard from Nina earlier today, in certain cases, we will also move our intellectual property into new companies, form with external partners but where we have future strategic rights. This is another way to leverage our R&D spend and drive innovation and growth. Our announcement today of our investment into Half Moon Medical is a great example of this. We formed Half Moon in 2017 with The Foundry, the premier medical device incubator. Along with The Foundry, we contributed IP, mitral valve know-how and some money to enable this new company to help drive important innovation for our future. We've demonstrated that we are allocating capital in new and different ways to significantly expand the level of technological development across our portfolio to accelerate revenue growth and to increase our WAMGR. Near term, we see a great opportunity as the investments we've made over the past several years come to fruition, generate strong returns, and at a minimum, close the gap to our WAMGR, which has been approximately 5% prior to the pandemic. And we want the wind at our backs by ensuring we are participating in fast growth markets. This comes through thoughtful portfolio management and capital allocation. We intend to increase our WAMGR over time by deploying our capital to faster-growing markets, such as robotics, renal denervation, ischemic stroke, diabetes and neuromodulation. While we're increasing our investment in internal and external innovation, that doesn't mean we're willing to compromise on margins. We are equally focused on operational excellence. We are still executing our enterprise excellence program, which is exceeding our expectations, and we still have additional savings to capture. We've recognized over half of the expected cost to date and forecast savings and leverage to surpass our original $3 billion estimate. In addition, last month, we announced that we're initiating our simplification program as we implement our new operating model. This will result in pretax restructuring costs of approximately $400 million to $450 million, the majority of which should be incurred by the end of fiscal year '22. Importantly, we expect that program to generate savings starting later this fiscal year. And by the end of fiscal '22, we should fully realize annual ongoing savings of $450 million to $475 million. These cost savings will be primarily in SG&A and also COGS as we remove the group infrastructure and consolidate manufacturing from the groups to the enterprise level. We will also continue to ensure our enabling functions and regions drive efficiencies in areas such as procure-to-pay and order-to-cash. Taken together, our enterprise excellence and simplification programs create additional capacity to fund investments, not only in R&D, but also in sales and marketing. These will help ensure our innovation pipeline remains full, and we have strong commercial execution around new product launches to accelerate revenue growth. We expect that a combination of our revenue growth and our efficiency initiatives, offset by our ongoing investment in innovation and commercial capabilities, will drive a compound annual EPS growth of 8-plus percent over our long-range plan. We will be focused on driving 8-plus percent each year. However, if a year has a strong external headwind, like significant currency movements, we will not sacrifice our focus on and investment in the long term. That's why we commit to delivering 8-plus percent over our planning horizon. Our operating margins will increase as we drive efficiencies and leverage down the P&L. And while our bias is to reinvest incremental savings to accelerate and sustain long-term revenue growth, there is always a potential for upside to flow through to the bottom line. While we accelerate growth, generating strong free cash flow remains a priority and is something the whole company is focused on. We are committed to sustaining what we've achieved in recent years, significantly improving our free cash flow conversion from 55% in fiscal year '18 to over 80% in the past 2 years. While we will see some short-term impacts from COVID-19, we expect to be back on track as we emerge from the pandemic, and we continue to target a greater than 80% cash conversion ratio over our long-term plan, which remains above our peer average. We also continue to target returning greater than 50% of free cash flow to shareholders, primarily through our dividend. We are committed to growing our dividend roughly in line with earnings. In May, we raised it by the same amount as the prior year, an increase of 7% despite the pandemic. This was our 43rd consecutive year of increasing our dividend, and we are proud to be a member of the S&P dividend aristocrats. Today, our current yield of approximately 2% is in the upper quartile of S&P 500 health care companies. Share repurchases are less of a priority today, given the opportunities we see to generate strong returns through tuck-in acquisitions. That said, we don't intend to hoard cash on our balance sheet. If we go through an extended period where there are fewer opportunities to execute disciplined M&A, we will look to return cash to shareholders through share repurchase. Medtronic is in a strong financial position with a robust balance sheet. We have approximately $13 billion in cash and investments with no long-term debt maturing until 2022. We've also been able to significantly lower our interest expense with our capital markets activities, enhanced further by our recent activity in the euro debt markets, followed by more U.S. debt tenders. And we continue to target an A credit profile. We saw the importance of this over the past several months, enabling us to differentially invest during the pandemic when several of our competitors were focused on cutting investments and raising capital, some of which diluted shareholders. Taken all together, we expect that our accelerating growth, significant free cash flow generation, balance sheet strength and disciplined capital allocation strategy will drive strong double-digit total shareholder return. Finally, if it's not already evident throughout the day, we are very excited about Medtronic's future prospects. And we are confident in our ability to increase our WAMGR and sustainably accelerate annual organic revenue growth to 5-plus percent. Thank you for your attention. I'll now join Geoff for some Q&A. And in the meantime, Ryan, can you please remind the analysts how they can ask a question?

Sure. I'm happy to do that, Karen. [Operator Instructions] So taking a look now, let's go to the line of Vijay Kumar to start. Vijay, are you there?

Yes, Ryan. A great presentation, guys. Geoff, maybe a big picture question for you. So if I look at the 2 messages, that was loud and clear, right? This is a new confident, aggressive Medtronic. You guys were not shy of highlighting your product capabilities, and even in some cases, highlighting how Medtronic's products were superior to peers. How do you reconcile this share gain messaging along with the 5-plus percent on the top line? Because my understanding is the market is growing at 5 plus but if I just go through your product lines and that message of share gains, shouldn't this be perhaps 5 plus, perhaps plus means plenty of room for upside here? Is that the message?

Well, good to talk to you, Vijay, and thanks for that question. Well, first of all, look, if you go back to the last quarter before the pandemic, we grew at like 3.5%, not at 5% plus. So we -- the first thing we need to do is we need to look across our businesses. Each end market, we've identified what is that market growing at and where do we need to be. And if we could just grow at the market at our WAMGR, right, we would be at that 5%, to your point, 5% plus. But we haven't been there. So we've got to make progress from where we've been. And we're making that progress. I think even in our Q1 earnings, you could see that. You could see the progress in several businesses where we are taking share where we hadn't been taking share before, and I expect in Q2 to see more of that. But first we got to get up to that WAMGR, right? We've got to get to that 5%. Over time? Yes, I would like to think the plus represents big upside over time. Okay? And you think about this, we talked about this second wave, we've got this lot of products being launched today, right, which you heard a lot about today and then we've got a second wave of innovation, this whole disruption opportunity we have and if you look at even Micro still has a lot of legs left and that we talked -- you heard Mike talked about it, it getting to a $2 billion market by 2030 and EV-ICD, which we obviously haven't launched yet, that's $1 billion by 2030. We're entering a soft-tissue robot space. I mean already in. As we get on in time, I would like to think that the plus does leave a lot of opportunity for upside. And we'll keep you posted on that as things get closer and we hit these milestones, we'll keep you posted and hopefully we can raise at that point in time. But as we sit here today, we feel good and comfortable to 5 plus.

Understood. That's helpful, Geoff. Then maybe related to that, on culture change. This something which is hard for people like me to model. I mean this endless days is different, right? This is -- you guys were confident, I don't know if [indiscernible] but this is, the messaging was different versus prior endless days. And I think one of the questions that the street struggles with is, look, I mean, Medtronic has always been great. But what about execution? What's changing here culturally? If I was a new shareholder in Medtronic, I get the confidence on the execution side. Culture is changing. That's one part. And I think you also touched about comp metric changes and how this perhaps changing here that might support this new operational unit that you're talking about, maybe that would be helpful.

Sure. Well, glad to hear that you could feel the energy through the virtual format. I was concerned about that because there's a lot more energy on this than the camera, I can assure you, than on your side. There's been -- I'm glad to see that you felt -- you feel the energy. What we're doing here to drive these changes is a pretty comprehensive set of changes. I mean -- and we're changing our operating model. But it all starts -- okay, let's -- it's very -- and very tangibly, it all starts with the pipeline. We talked about it's the best pipeline that we've had in our history. And what's so exciting about it is that all the products that we've just launched, we're launching now and product launches that are imminent, right? And then there's this second wave of innovation in the next 18 to 24 months with things like soft-tissue robot, when that becomes material, and RDN and EV-ICD. So it's -- we feel pretty good. So that gives us -- that alone gives us a lot of confidence but the opportunity to really maximize this opportunity and optimize this opportunity which in the past I don't think we've fully done. I don't think, historically, our technology leadership, our market share is not commensurate with our technology leadership. And even the size that's still in the markets that we've created like neuromodulation, for example, aren't as big as they should be because we've got to be, I think, pushed a little harder. So what are we doing here? All right. So let's -- it's -- we talked about the org change, which is really decentralizing decision rights in to the operating units. So you're empowering them. You're delayering the organization. And all of this should drive a more faster and a more nimble organization and provide us the visibility of these end markets. So we could see what -- how are things unfolding and how -- what is possible with these end markets. We talked about incentives. We are changing incentives, right? We -- already, we've changed our performance criteria. That's a little easier to do. You could do it quicker. And we've got market share in there. So that we're not -- so if you beat your plan but you're still not growing at or above the market, that's a problem. Okay? So we put that in there right away and what we're working on now, the comp changes would get at really, I won't drag you with all the detail, drag you through all the details, but it's a pivot towards growth. So there's a lot more emphasis on revenue growth in our comp plans. Market share will be in there as well and total shareholder return. Those are all in our long-term plans. But all of this, we're not going to take a step back, though, on our margin profile and our cash flow conversion. And then finally, there's the culture piece. And look, this starts to the top. You have to -- the executive committee, and including myself, we've got to model this behavior and our leadership. And I've been very close, myself and the executive committee, we're doing -- we stayed very close over the last couple of months in the development of this operating model with our vice president population and above, which is about 500 vice presidents globally, and gotten a lot of good feedback. We worked on this together, and I feel good about the primary culture changes. And I just sum them up in to 2 words. One is to be bold. The opportunities that are in front of us today are unprecedented, right? The -- this is a time health care markets are growing. There's this universal in need for improving outcomes, improving access, lowering costs. So that's always been there. But you have all this technology innovation going on inside of med tech and outside of med tech that we can really -- we can leverage. And so we have to be bold. We have to think big, and we have to expect more of ourselves, right? Expect more. So that's number one. We've got to reward people for having big ideas and having the courage to act on them. Okay, that's number one. Bold. Number two is this competitiveness. We are a mission-driven company and it is such a special place to be in a mission-driven company. But we do need to augment that with, I think, a higher competitive -- an increased competitive spirit, a greediness into the company. And we need this because as we open up these new markets like we're going to do with Ardian and EV-ICD or disrupt markets, too often, competitors come in right behind us, and from my humble opinion, take too much of the financial returns on these markets that I think should be go to Medtronic and our shareholders. And we need that one, for our shareholders, right? And two, that's the fuel to do this all over again. Because this company is hooked on going after big unmet needs and creating new markets and disrupting existing ones. And so that -- it's a comprehensive set of things. We've moved fairly quickly. I've been CEO for like roughly 5 months, and I think we've moved fairly quickly. We started working on this, though, roughly a year ago when I was first announced, myself and the executive committee and over time, we brought more people in. So we're feeling good. You could see the energy today. What I'd like to about today's format is you saw so many of our leaders and you can -- you've got a deeper dive into the technology, which is very important. But you got a deeper dive into Medtronic and the bench of talent we have, the diversity of thought, the diversity period and that -- all this together is why we're so excited.

Let's next go to the line of David Lewis. David?

Great. I have one for Karen and one for Geoff. Karen, can you just talk for a second about the EPS algorithm? It was a little more simple to understand back in 2019. If you grow the business 5%, 40 bps in margins, which is kind of in the midpoint of what you've said historically, 30 to 50 basis points. If that gets you to 6.5%, if I go into 2017, you still had tax rate that could come down a bit. You were more aggressive on the buyback, so it was very easy to see how you get to 8 plus. Help us understand how the algorithm looks now, how you see the outcome going forward? How you're still confident in the 8%? And I think what people really want -- because it's hard to judge performance here in the next 2 years, is to know that earnings numbers that are out there right now are achievable. I wonder if you'd share with us whether as you look at the consensus numbers these next 2 years, whether you're comfortable with those earnings numbers. And I have a quick one for Geoff.

Thanks, David. Appreciate the question. So just on the algorithm of going from the 5% to the 8%., we're focused on continuing to drive that operating margin improvement and that operating leverage that we've driven over the last couple of years. When you move from greater revenue growth, it's easier to drive operating leverage. So just growing expenses less than we're growing revenue is part of that equation. We've also got 2 important programs that drive savings: our enterprise excellence program that we've talked about before; and now our new simplification program, which is intended to drive $450 million to $475 million in savings by FY '22. We're going to use those savings to help drive the bottom line. We'll also use them to help reinvest. When you think about financial leverage, we've done a really good job on financial leverage over the last couple of years. Just look at our interest expense. With the capital markets transactions we've been doing, we are now in a very enviable position of having the lowest cost of debt, not just among our health care peers, but also just among a broader large-cap set of peers. And so when we look at that and we look at the backdrop of the political environment with some potential pressure to increase corporate taxes as opposed to decrease, it's unlikely that we'll be driving a lot of financial leverage going forward. Just in the near term, we have the annualized benefit next fiscal year of what we've driven in interest cost savings, so that will help us. But it's not something that we're focused on counting on long term. We will continue to focus on driving financial leverage everywhere we can, but it's not something that we're counting on in our long-range plan. So think of that algorithm as being driven largely by operating leverage, and we're really confident between our programs, between our culture now and between our ability to drive that top line growth of 5-plus percent that we will get that algorithm correct, and ultimately focus on driving that double-digit shareholder return.

Okay. Very helpful. Karen, I don't know if you're willing to comment on how you see the earnings expectations in the next couple of years. Perhaps you're not, but if you are, I'd love to hear it. But I'll move on Geoff as well and ask the second question. So Geoff, if you listen to Karen, she's sort of suggesting that the way to get to that 8% number is not by getting more than 30 to 50 bps a year. It's actually by getting that 5 higher. And I wondered the message today was WAMGR's 5. We hold share, that's 5%. I wonder if this M&A piece could be kind of a perhaps a secret sauce here, Geoff. So you deployed $1.6 billion most recently. What could that $1.6 billion do the next couple of years in terms of revenue? And a lot of your growth-oriented peers have driven about 1 point of growth a year through M&A. Is that how we should think about it, 5% WAMGR, hold share is 5%, M&A should be gravy on top of that? And that's kind of how you get this greater growth to get to the 8% Karen's referring to?

The short answer is, I guess, the answer is yes. I mean first of all, I agree with your assessment of Karen's commentary, it comes down that 5%. We have to get 5-plus percent to make it easier to get to the 8% so we have enough room to invest in all these great opportunities. And that whole idea -- I'll take a short detour here. The idea of not fully funding the opportunities that we have in front of us is the thing that will keep me awake at night. We have to figure that out, and we will figure that out one way or another. And you can already see some creativity. We will -- Karen mentioned some of the programs we have that are rightsizing the organization in places and making savings that we could put into R&D. We're using our balance sheet more aggressively, David, to your point on M&A. Regular to straight up M&A, structured deals, creative things like you heard about Half Moon, the Blackstone partnership and so on. Venture, using Venture more effectively. We have got to -- we just -- when we have the market opportunity, the patient opportunity, the market opportunity, the capabilities that we have in Medtronic, we've got to figure out a way to fund these things. And M&A will be a big piece of it, I think. Our M&A team, I think, is -- it executes very well, and our businesses are really, especially in this new model, where we're really looking at each and every end market. We're seeing already a lot more targets that maybe we wouldn't have seen before. And so the hope is that -- and the expectation, I should say, is that M&A will add a point or so a year. And then that, over time, we will grow what we buy. We're not buying growth, and that will become organic growth, and that will help the 5% and help the plus side of the 5%.

Let's next go to the line of Kaila Krum. Kaila?

Great. Congrats on pulling off this very cool virtual format. So one for Geoff to start. So the new operating model you guys are putting into place for the company, I mean, you effectively did this in RTG. You ultimately saw success with that strategy. But can you talk about perhaps some of the challenges you originally faced or perhaps what you learned as you implemented the strategy in RTG just 'cause that has influenced how you guys are putting this into place today? I think that perspective would be helpful.

Yes, sure. I think, first of all, this is, I think, more aggressive than what we did at RTG. There's a lot more smart people around the table. We have -- with all the other people on ExCom focused on this. So I think it's -- there's some unique aspects to this operating model that we didn't have the luxury doing at RTG. But a lot of it, we did learn quite a few lessons at RTG. One, this whole concept of unnesting the businesses. RTG was kind of 3 big business units that made up roughly 1/4 of the company. And we took those 3 big business units, and we did make them 9. Nine focused and a very accountable, I'll get to the accountability in a second, but 9 focused operating units focused on a particular end market, a narrow set of conditions, narrow but deep; a specialist call point. And it provided me and the leadership team at RTG really good visibility on those markets. And we could see the trends, see the opportunities and be proactive. And if we miss something, we can react quickly. And so that is -- that was a swing thought, the original swing thought for this whole operating model changes to is to change Medtronic from this $30 billion company to $31 billion company. We didn't quite get to $30 billion. We're down to like $21.5 billion. But over time, I'm convinced we'll get to the $30 billion. To provide that visibility, we also took out layers. And I do think layers, once you get to a certain number of layers, it hurts. It slows things down. It could stifle innovation and it can frustrate people. So we took out a layer or 2 across the organization, depending on where you are. That was another lesson learned from RTG. And the lesson for me personally is to be decisive on talent. Promote the people that have the right attitude and are showing the right skills, promote them. Don't promote them faster than conventional wisdom would apply. The converse is true, too. If somebody isn't performing or somebody, even if they're performing, if they don't have the right -- if they're not bought into the culture, you've got to move quickly. Something that's not bought into the culture is a cancer, and you just can't have that. And so I feel good about the team we have here right now at Medtronic. We've come together quite a bit. We spent -- the Executive Committee, I would argue, spent more time in the last 5 months than the last 5 years together. Now it's a lot of it's been Zoom, okay? But I've -- we've been talking quite a bit on this and worked on this org design and the operating model, the incentives, everything has been designed with the Executive Committee, and we've gone deeper into our organization as well into the -- I mentioned the 500-plus BP. So I feel like we've got buy-in. We're getting a lot of good feedback. And employ morale right now is at an all-time high. And I'm not just -- this isn't hyperbole measure. This is -- we measure employee morale with employee survey scores. We do it sometimes annually, sometimes lately every 6 months. It's a very comprehensive survey. And coming out of the pandemic and as we are making these changes, the morale just jumped way up. It's the highest we've seen ever since we've been doing these scores and we've been doing them for a long time. So I feel like these changes are welcome changes. . And look, the last thing I'll say is if something is not working, we can change it. I'd like to -- our -- as the Executive Committee, our ego isn't that big that if we made -- if we got something wrong, we've got to change it. But I do think the core design principles here are the right ones, and that is decentralization, take out the layers and empower, empower people. That opens up all kinds of opportunities. So we've empowered. But at the enterprise level, we have a very short list of things that we are focused on that I would say, leverage our size and scale. Technology platforms is, for me, the top of the list, things like robotics that cut across our surgical business, soft tissue robot, our spine business. And we have a robot in cranial, and I could see us adding other robots. Battery technology. You heard today about the advantages of our battery technology and how that's really helping right now in our -- in the pelvic health space, overactive bladders. That space moves to rechargeable and our competitors dealing with these recharge issues and this battery death issue, and that's something we solved 10 years ago, 15 years ago, right? And so these enterprise technologies are super important. We are advancing the technology and science at the -- with enterprise level investments that help all of our businesses. And other areas are operations, our manufacturing footprint, our distribution footprint is large and to lower cost of goods sold, and at the same time, improve quality. The FDA holds us to a very high standard, and so that is something we're watching. So this play small and play big. The big is the 2 enterprise things I just mentioned, the small is the focused business units. This is what the core of the model is. And yes, RTG was a good test case for some of it. And -- but some of it is new for the company. And I'm happy to report employee morale is high, and we get some momentum. But we still have -- from my perspective, we still have something to prove here, and I'm confident we're going to prove that.

Great. And then just a quick follow-up. I guess as you look across all of your 20 new operating segments and where you ultimately want to be in each of those segments. I mean is the goal to be #1 or #2 in each of these categories? And if yes, which segments might require inorganic investment to get there?

Well, yes. The ASP -- the goal here is to be #1 in each one of these things. And in some of these segments, we need to redefine it. So sometimes being #1 isn't even good enough when you have a big market opportunity. That's why I'm saying, we got to be bold and expect more from ourselves. And sometimes, historically, we haven't done that, like legacy neuromodulation. We rested on our laurels a little bit too much. And that has stopped under Brett Wall's leadership. They are definitely bold and aggressive. But look, the inorganic opportunities, it's something -- it's areas -- the way I look at it, Kaila, is areas that we are -- we just can't do something internally or were significantly behind. So like we did, like I look at spine, we did spine robotics. We -- as we saw robotics platforms like Mazor coming to the market, we were pretty far behind. So we felt that was an acquisition opportunity. So it would have to be something where we're just -- we just are so far behind or we're missing a capability. And don't forget these kind of hybrid structure deals like we just announced with Half Moon Medical here where we're contributing some capabilities in IP and they're contributing some capabilities and focus, and we put in some money. So and these would -- I think there's almost every of our 20 operating units now, if you look at them and you listen to those leaders in our internal reviews, they all have inorganic opportunities that they're excited about. And the way this is working now is myself, Karen, the 4 portfolio Executive Vice Presidents you heard from today and Mike Weinstein, we sit around in a monthly meeting and are focused on this capital allocation because we -- our #1 job, one of our top jobs as an Executive Committee is allocating the capital to the high-growth segments. Because this growing at our WAMGR is about execution. Strategy and decisive capital allocation should grow your WAMGR. And that's a big job for us, a big opportunity for us.

Thanks, Kaila. Next, let's go to the line of Chris Pasquale. Chris?

One for Karen and then one for Geoff on the business development. So Karen, I wanted to clarify the comments on internal investment. You're already at close to a $2.5 billion R&D run rate now. So as we think about the next few years, does R&D spending need to grow at close to the revenue growth rate? Or can you at least get some modest leverage at that line?

Yes. Thanks for that question, Chris. We do intend to grow our R&D. That's one of the key parameters for our investment. And so I think over your models, you can anticipate that it grows roughly in line with revenue. It's not something where we're going to focus on driving leverage. There will be some natural leverage as we just try to be efficient in our R&D spend, but it's not an area where we're focused driving leverage like SG&A. So I would roughly in line with revenue growth.

That's helpful. And then Geoff, it's encouraging to see the company being more aggressive on the M&A front and adding to the portfolio. On the other side of the ledger, there have been some calls over time for Medtronic to consider divesting some slower growing businesses. It sounds from today like the strategy is to develop winning technologies in those segments rather than pumping on them. But as you look at the portfolio today, do you think it's likely that you exit any businesses you're in now over the next couple of years? Or is that really not on the table?

Well, we're always looking at the portfolio, right? And right now, I feel good about where we stand with the portfolio. And just I'd ask you to remember that we've put this active portfolio management process in place this rigor and like I said earlier, we look at it monthly. And we have businesses that are high growth, big growth opportunities that require more R&D and maybe some more inorganic. And we have others that might be slower growth but throw off a lot of cash and profit that we can use to help fund some of the R&D and the higher growth opportunities. So the whole portfolio has to work together. But if we find a business that is not -- there has to be some minimum level of growth here because if not, that's -- and minimum level of profitably. If that -- if we can't disrupt that or optimize that, then we should look to divest that. So we are always looking. And I think it was a few years ago, we did it in 2017, I believe we did a pretty big divestiture with the Supplies business, sold that to Cardinal for that reason. It just wasn't quite growing and we didn't see a way to change that growth and profit profile. But we will -- for big markets, we will look at it and assess our opportunity like we did in spine. I mean, I would argue that's a good example where it was slow growth if you look at just spine implants, and by injecting robotics and enabling technology, we've gotten that growth up pre-COVID and it will come back after COVID to mid-single digits with all that technology together. And what they've done, and you heard from Mike Marinaro today and a couple of times on what they have done with cardiac rhythm, which a couple of years ago was pretty slow growth and changed that, redefined that with technology. But if you can't do that, and/or just doesn't fit, then we should divest. And we are looking at that constantly. And we're really focused on that WAMGR. And so that should -- we're having these type of conversations. I'll leave it at that. But I'm not going to signal any divestitures, anything in particular as we sit here right now. We're liking our portfolio.

Thanks, Chris. Next, let's go to the line of Robbie Marcus. Robbie?

Karen, maybe a bit of a clarification here. Just wanted to think about maybe the cadence within the guidance range? And what's the baseline we should be thinking about, particularly for the 8% plus EPS CAGR? Should we be thinking about it more in the 4%, 5% growth range earlier, moving to 5% to 6% as you get some of the pipeline and newer launches moving forward?

Yes. Thanks for the clarification question, Robbie. We're focused and committed on that 8%. We've been focused and committed on it for a while now. And it's a focus on an annual basis. That said, we've got the pandemic going on right now. And so obviously, that's impacting our bottom line in FY '21. And in FY '22, pending the recovery that we're seeing great strength from right now, FY '22 could be a significant improvement off a very depressed base, so it will grow much greater than that 8% that we're talking about. So really, I would think about the 8% as something starting now, and we're focused on it over a long range. So there could be some years, and we've signaled FX as a potential year where, if we have more than modest volatility in FX, that may be a year where we don't get to that 8%. But over the long range, we are committed to it. And that long range has been and continues right now. Hopefully, that helps.

Yes, that's great. Maybe just a quick follow-up here. The pandemic as brought a lot of headwinds and potential tailwinds to the med tech industry. Is there anything that Medtronic sees as a maybe a permanent headwind that you need to adapt to going forward or maybe some tailwinds that have evolved? I know you were very aggressive in investing, particularly in the workforce throughout the pandemic. Your scores are high from employees. Does that give you a good place to maybe bring some really high quality talent, Medtronic from competitors here?

Well, maybe I'll -- thanks for that question, Robbie. I'll take a shot at that. On your last point, clearly, it was intense during the pandemic for all the reasons that many other companies faced. But for us, in particular, we also had this ventilator, the spike in ventilator demand, and we felt because it was true people's lives depending on the actions we took. And so we did, I think, a lot of great things. You've heard the story about the open sourcing and how we've ramped up ventilator production. But what made this all -- our mission, the mission of Medtronic really clarified what we needed to do in times of crisis, not just for the leadership of the company, but deep into the company. So these decisions can be made quickly and not have to kind of -- bold decisions can be made quickly in time of crisis because our mission clarifies and empowers people. And that -- and to show up like we did during the pandemic highlighted the power of this 60-year-old mission. And that mission rings true today. It's more powerful today than it was 60 years ago when it was written. And I think in today's society, people want to work for companies that authentically stand for something and back it up with their actions and in their investments and the choices that they make. And right now, you're seeing in a number of different awards we've been -- recognition we've gotten as a company and about what we've done. And this is a powerful way to attract talent. And I think people want to work for a company that stands for something now more than ever. And we definitely -- and we need these people because innovation, this is all about innovation. Innovation is a people game and you need the best people. And the best people now are -- this is a major screen for who they work for. And so you heard me talk about earlier today about the mission and ESG and what it means for this company. So I do think it's very powerful. This company is a competitive advantage. Robbie, in terms of other things from the pandemic, it did accelerate, I'd say, inspire and accelerate some of the org changes because we saw how -- when we focus and we -- the organizational silos come down, and we kind of skipped layers during the -- as we made decisions during the pandemic, it inspired us to see what we can really do. The other thing, so I think that really -- that is something that I think really helped us with the model changes. And the last thing I'd say is just our view on partnerships. I don't want to say we were too internally focused on, hey, we can solve every problem. But I would say that we weren't externally focused enough. And we -- my view of partnerships has changed. I mean we did partnerships with companies I've never even heard of before. So when we open sourced the ventilator, we went out there. Instead of saying to our supply chain, here's a problem or here's a spec, we said, we have a problem, can you help us solve it? And I was amazed at what came back. I mean, we partnered with -- we learned a lot about supply chain from automotive companies. We partnered with a group out of Vietnam called Vingroup that, up to that point, I hadn't heard of them. They really helped us on the ventilator side. We partnered with Intel, who's taught us a lot about the power of edge computing. And when you bring in some of the new computational power on our devices, what it can do, that really helped us remotely control these ventilators and from outside the room and change that. Even with Elon Musk, who gave us a call when he saw the open source opportunity and helped us solve a very difficult part to manufacture this proportional solenoid valve. Who knew that, that same product, that same component is in our ventilators in his spacecraft? So going out to these technology companies and asking them for help on a problem or help solve an opportunity is something that I'm very excited about. And this whole tech into med tech concept, we are working today actively with a number of the big named tech companies as well as smaller start-up companies. And I think this is going to help accelerate our innovation. Like I said, it's almost like a third vector. It's like a new vector of innovation for us, all these digital opportunities coming from the tech world.

Thank you, Robbie. Let's next go to Lee Hambright. Lee?

Thanks, Ryan. So one for Geoff. You've talked about the new operating structure as a way to decentralize the organization. Usually, decentralization costs money. You've got to build specialized sales forces. You need to click new resources. In some cases, to create P&L responsibility in the operating units. You've given your message that you're saving hundreds of millions of dollars with this reorg. A skeptic might say that you're doing more centralization here than decentralization. How do you respond to that? And I've got one follow-up.

Well, I think it's a good question. I mean, some of our bigger expense pools, like you mentioned, dedicated sales forces, we already had the dedicated sales forces. It was some of the sales management that was amalgamative, if you will, combined, and we are spiking that out and pushing and having them reporting to the operating units. The other thing that you got to remember, it wasn't that long ago, in 2015, we closed on the Covidien deal. We took 2 90,000 or 45,000-person organizations and put them together. And yes, we took out a lot of what I would say, the synergies we got, the several billion in synergies, a lot of it came from real duplicative costs like real estate and separate headquarters in every country and a separate corporate headquarters. And that allowed us to take out a lot of cost. But there's still -- as we put the 2 companies together, we went to a fairly rigid matrix, if you will, and a little [ top of the --] and over time, bureaucracy is built up. And so in this new op model, taking out some of -- clarifying decision rights, I would argue in our matrix -- like I'll take it like in Europe, in sales management. We have the region doing some sales management. We had some of the businesses winning. It wasn't clear who was doing it. And in some cases, it was done twice. So we had some opportunity, I'll say, in clarifying decision rights to streamline the organization. And that is where some of the -- a lot of the savings are coming from.

That's helpful, Geoff. Maybe just one follow-up. General investors or generalist investors watching today might feel a little bit overwhelmed. There's a lot of technology here. It would be hard to know where to focus your diligence efforts. On the product front, can you boil the story down to 3 or 4 or 5 things? Or is that just impossible to do when you're the world's largest med tech company?

Well, look, that's a very good question. And I'd say the one thing I would -- for a generalist investor, the one thing you can walk away from is, look, we've been performing below our WAMGR, right? And we've been -- and I would argue, based on the feedback I've gotten from analysts and investors, that fact has driven us trading at a discount. And if we can just grow at our WAMGR, then our growth would increase fairly materially. And so just that alone, and this new operating model, the health of our balance sheet, the scientific underpinnings of the company and this mission-driven culture now we're adding this competitive grit to it, I like our chances to get to that 5% plus just across the board. That's the one thing I'd say. Now the plus, the upside, you just look at some of these big markets that are going to be -- they're new like renal denervation that -- this isn't based on -- this is based on science and now we have the second arm of this pivotal trial that to come -- we have to bring that one home and land that one. But we feel very good about that, and that will open up a $3 billion market where we're the only one by the end of the decade. We're disrupting a lot of big markets like cardiac rhythm and with Micra and EV ICD. We're entering into a large surgical robotics market where there's one player. We're coming in with a differentiated offering, and we're coming into a market where there's insatiable hunger for a second player. And we're going to be that second entrant, and we've got strong aspirations there. We're in neuromodulation. We invented neuromodulation. And it's not a very well understood market, quite frankly, for the general public, if you will, generalist investors. But think of it this way, we're going right after pharma with this. I think the neuromodulation technologies can replace a lot of our augment, a lot of pharmaceutical products that have, I think, a different side effect profile, the neuromodulation. So the second thing I'd say, Lee, on this is look at the big market opportunities that are out there. So if I just say 2 things, just grow it, our WAMGR and I gave you all the reasons why that's going to happen, and that would increase the growth. And the second is look at all these big market opportunities. We don't have to hit them all. Our expectation is to hit them all. We're funding all of them like they are going to come to fruition. And -- but we don't have to hit them all to create a big upside for the company.

Thank you, Lee. Let's next go to the line of Ed Ridley-Day. Ed?

Yes. Thank you, and thanks for the great presentations today focusing on the pipeline. Geoff, to bring it back to your operational reorganization, very good to see increasing autonomy for your divisional heads. How do you feel you've got a control though, of the returns generated and the profitability if they are going to be very focused on growth, which is great. But I just -- first, my first part of my question is whether with you or Karen feel you have the tools in place to control the profitability as they drive this growth?

Well, I think we have the tools in place. I think the question is the insights in place to do the right capital allocation. And I believe we do. So in this operating model changes, like we've empowered all these 20 operating unit leaders. but the former, what we used to call group leaders, which I used to be one before assuming this job, so Brett Wall, Bob White, Mike Coyle and Sean Salmon, with the exception of Sean. Sean is still an operator. He's running diabetes. But the other 3 guys are now like -- I look at them like almost like private equity leaders that have a portfolio of businesses and their job is really capital allocation, but not for the company. So those 3 guys, plus Sean, working with myself and Karen, Michael Weinstein, every month, looking at the capital allocation among these businesses. And some -- some businesses are going to get targets that are lower growth, but higher profit margin and a higher cash flow contribution. Others are going to have the opportunity to spend more on R&D. And this is a formula. If you have the right insights around the tail, these are some seasoned veterans that have diverse backgrounds, diverse experiences that coming together on a regular basis and having this debate is really healthy. And I know we're all learning, and I'm confident that we'll make the right decisions. We'll make some mistakes, but we'll correct them quickly. But I'm confident we'll make the right big decisions, and then optimize and know when to press for more earnings and more when to allow the spend to invest in growth. And again, this is something I did in our Restorative Therapies Group. And we pivoted to some big investments that you're now seeing come out like in neuromodulation and into deep brain stimulation, into pelvic Health. We saw the market opportunity. We saw the competition, we felt the competition. And we made -- we moved money into those businesses and funded them heavily. 20% of sales went into R&D in some of those areas for a number of years. And other businesses contributed extra earnings to pay for that. And at the end, it all worked out. So that's the kind of mindset here. So I do feel we have the tools. I feel like we have the rigor. And most importantly, I feel we have the right people. There's a lot of judgment calls here, and it's based on experience. And I feel like we have the right people to do this.

And I would say, in addition to capital allocation, Ed, that we have proven over the last couple of years that we can drive that operating leverage and that operating margin expansion. And so it's -- we've got the tools in place to do that, to focus on driving that bottom line.

That's very helpful. And just a quick follow-up then. I mean it's great to see this initiative on the operating front. I mean, if we would go forward 5-plus years, Geoff, would you like to be to see us talking about a Medtronic business system? I mean, ultimately, we haven't heard that some of the world's -- that some of the well-known companies with fantastic business systems use today. But it seems to be that perhaps in turn, you're already, you're thinking about the culture change in that way by introducing some of those initiatives to effectively drive an overall cultural change in Medtronic?

You broke up a little bit on me there, Ed, but on the culture change, it is a specific item. You can't just talk -- I mean, you have to model it. You talk about it a lot, but you've got to drive it. And so we have a number of organizations, some pointed at our field, some pointed at our management to help us drive this culture change. It has to be very specific. We're working quite a bit on this, and this is something I view as a big part of my job personally to drive this culture change. And it's an evolution. It's -- we want to maintain the mission and build on the mission. And Omar, my predecessor, I -- one of the things, as I look back over the 9 years, I mean, he did a phenomenal job taking this, at that time, 50-year-old mission. And not just maintaining it, he built on it. He operationalized it. Not only is it inspirational to this company like it's always been, alleviate pain, restore health, extend life. He operationalized it so that it defines what we're doing strategically, and it guides us day-to-day. So we want to keep that and continue to build on that. But we're adding -- we are adding these 2 concepts of bold thinking and actions and competitiveness. And we are driving that through a lot of education and discussion and in modeling the right behavior, rewarding the right behavior, changing our incentives. So it is a comprehensive, fairly rigorous, I would say, plan of attack here on this. And I would like to -- we're known as, I think, the mission company, the company that opens up new markets. But I don't think, if you pulled people, and I've kind of done this, that we're known for this competitive grit. And -- but I believe we're going to get there. People are hungry for this. Honestly, when I started talking about this internally, I was afraid I was going to insult 90,000 people. Who are you to say I'm not competitive enough? But I was overwhelmed with the response. And people are hungry for this. People want to go out there and make our market share equal to our technology leadership. And people have gotten around that. That is part of our mission, right? That is part of our mission. That will provide the fuel that we need to reinvest to kind of keep doing this all over again.

Thank you, Ed. Next, let's go to the line of Joanne Wuensch. Joanne?

There's 2 of them. There are 2 words I have not heard all day yet and that's emerging markets. And I'm just curious how, in the new organizational structure, that overlays onto this. And then I'm going to ask my second question, which is it sounds as if you've set up an excellent game plan, revitalized the culture, worked with the revitalized pipeline. How do you measure success? And how do you keep monitoring it, the focus and the game plan to tweak it and pivot as necessary?

Well, Joanne, great. Your first question is a great observation. We debated that, and we actually -- we have more emerging market material initially and we decided not to include it because we wanted to keep this focused on -- to a question earlier, it's a big company. I don't want too many messages, so we kept it really focused on really innovation. Innovation and then the operating model changes. But the emerging market piece is very much front and center. That's another area that I think Omar led, not just Medtronic, but in med tech. And our emerging market business, 16% of the company at this point, and is when you look at -- as we looked at -- as the Executive Committee, we looked at our plan going forward. We look at emerging market growth as a distinct item. It's an independent growth vector. And just doing -- we've come a long way under Omar's leadership on emerging markets. We've all learned so much. Our business has grown. It's very exciting. But we can't rest on our laurels there either. We've got to keep evolving. And I think the next big step forward in emerging markets is localizing our technologies in some of these bigger emerging markets. And so localization in like areas like China is going to be a big deal going forward. We didn't talk a lot about it today, but you will continue to hear about that in different forums and on earnings calls because it is a big part of the company. So I don't want you to think we're taking a step back on that at all. It's still very important. And your question on how do you monitor success? I don't know, Karen, if you want to add anything to this. I mean, for us, the mission is first. And you feel the mission and we survey our employees and our customers and all our stakeholders. And we've got to keep that front and center to make sure that we are fulfilling the mission. But driving the innovation is a big part of that mission. And so that innovation should translate into growth. So I'd like to see us growing in our markets. And for me, personally, when I look back in a few years, I want to know that we created a couple of new standards of care. Whether it's entering a new market or disrupting an existing market, that is, to me, what fuels this company's mission and what will fuel us financially as well, is creating news or disrupting existing standards of care like we're doing in spine or -- and creating new standards of care like we plan to do in renal denervation. If you do just that and you do it frequently enough, and from my perspective, there's never enough, but that will be success. Everything will fall from there. Everything falls from there. Innovation that translates into clinical and economic outcomes for health care and patients and we'll be just fine. So that is the focus. Incrementalism right now in this day and age is not good enough. So we're going to balance some continuous innovation with disruption and invention.

And I would just add, Joanne, 2 things. One on emerging markets. We still expect to grow our emerging markets double digits so that is still very much part of the equation. And then secondly, just on success, to touch on what Geoff said, I think of things in financial terms. So I'll think of success as closing the gap to our WAMGR, we are well along our way there. And then growing above our WAMGR and taking and winning share. So that's things we will be measuring in financial terms. And then for my other colleagues who think about things in non-financial terms, we'll be focused on impacting more and more patients every second around the world.

Thank you, Joanne. I think we've got time for one more question. Let's go to the line of Bob Hopkins. Bob?

Great. Thank you very much, Ryan, and thanks for today. Geoff, I wanted to get your quick thoughts on the state of the recovery in [ certain ] procedures across the globe. Specifically, how confident are you that the things will continue to get better despite what's going on with COVID? Investors remain pretty skittish on this topic. And obviously, you're the largest med tech company in the world, I would love to get your kind of updated views on where we are.

Bob, good to hear from you, and thanks for the question. Yes, it is a question we look at quite a bit. And over the last, I'd say, 2 months, I've talked to over 100 hospital executives, C-Suite, CEO, including CEOs, not all of them one-on-one, but because we have a couple of group Zoom calls, if you will, just us and a number of our customers to gauge this very question. And the summary I would give is there is a very strong commitment from health care systems to keep elective cases going despite the spike in cases or a spike, a potential spike in cases. They feel like how they've learned a lot over the last 6 months, and they can do this safely. And they've shared a lot of best practices with each other. I was pretty surprised at how much these hospitals, even local competitors, are talking to each other and sharing best practices. I think that's something that you see in health care in general. It is nice to see it extend to executives and hospitals and what they're doing there. So I feel good about it. Now there could be some states that enact some sort of legislation or executive order, if you will, to stop the elective cases. I've heard rumblings of that. But I'm skeptical of that because this is patients. I mean, the hospitals are saying, we can do this. So why would a state enact an executive order that could hurt, that could harm people, prevent people from getting the right care. So I feel pretty good about that. And then the other question is, are we working through this backlog of patients. That is a question that I think becomes less of a risk every day. You heard Mike Coyle talk about today some of the cardiovascular procedures are back to year-over-year growth and/or back to pre-COVID levels. Cardiac rhythm and TAVR is back before pre-COVID levels and stenting. And so what we are seeing is that the more -- the least elective and the middle of the bucket, if you will, the kind of moderately elective, that those cases are back. We feel like those patients have -- we don't have a backlog issue. There may be a little bit of that in some of the more elective areas like you're seeing in some of our neuroscience businesses. But by and large, we don't think that this backlog issue is very material anymore.

Okay. And then just one last one for Karen. I realize that the 8% plus on the EPS side is kind of over the course of a long range plan. But is there a base number or base level as a starting point that we should think about? Like is that fiscal [ 2019 ]?

We lost you. Bob, I don't know if you can repeat your question. We lost the important part of the tail end.

Sorry about that. I'm just wondering on the 8% plus, the base year, should we consider 2019 the base year from which you grow that 8% over the course of the LRP?

Yes. No, thanks for that question. Clearly, you can think about it as FY '19 as a base year because it was pre-COVID, if you think about it from the quarter's pre-COVID. You can also think about it as just over the long range. Whenever you measure it over a 3-year period, we're going to be focused on that 8%. But we're also going to be focused on it on an annual period. And really, it's just exogenous big events that could take us off of that. And that's why we say over the long range plan.

Thank you, Bob, and thanks to all the analysts today for your thoughtful questions. We really appreciate it. And thanks for all of you for joining today, participating today and for your interest in Medtronic. And I'll now turn it over to Geoff for closing remarks. Geoff?

All right. Thank you, Ryan. It's been a great day, I think. I appreciate everybody's attention. And I hope, after listening to all of today's presentations, I hope that you feel the energy that's resonating throughout this company. We have a lot of momentum, and we're staring at a very bright future. I believe we're at the front end of a significant acceleration of our growth. As we've talked about, the pipeline is here. We're already seeing the results, and there's more to come. We're going on the offensive, and you heard several times today, we're taking share. Revenue is accelerating, and we're doing this without taking a step back on profitability and cash flow conversion. So we're creating and disrupting big markets. In robotics, we're deploying a digital ecosystem and entering in a disruptive way. In markets like cardiac rhythm management and neuromod, where we're the leaders, we're fundamentally redefining these markets with new technology. And then there are the big future markets in med tech like renal denervation, where we're leading the way. And all of this, all of this will be amplified by advances coming from the tech world, which we talked about. Historically, med tech innovation has primarily been based on the application of electrical and mechanical technologies to human physiology. But now, there's a whole new vector of innovation with digital. And you're seeing this with the emergence of big data sets and tremendous advancements in analytics and with AI and machine learning. But you're also seeing it in microelectronics and advancements in battery technology and in areas like robotics. There's been -- there's quantum increases in computational power, both in the cloud and with edge computing, which we can put right into our devices. And then you're seeing advances in manufacturing techniques like wafer scale, which is bringing down the cost of these devices and have -- it has the potential to make products like our LINQ into an affordable ubiquitous super sensor. We're harnessing the advancement of these and other technologies that are redefining the tech world today to enhance and be relevant within health care and help our products. We're already working with several technology partners. Plus, we've already made a number of investments, including digital surgery, which includes image analysis, big data and artificial intelligence. Also advances in microelectronics that led to Micra and Interstim Micro; artificial intelligence, which is showing up in diabetes with Nutrino and Klue, as well as in our spine business with the announced acquisition of Medicrea. And we're also merging data and analytics into our surgical robot. We're getting closer to autonomous and self-learning devices. In fact, we already have this with a personalized algorithm in our high-power CRM devices that actually learns over time to better terminate deadly arrhythmias. And when it comes to data, the amount of information we generate off our devices today is massive. And it's only increasing. And we're turning this data into insights and into action. And with all of these advances, Medtronic is in a unique position to put the tech into med tech. But to make all this happen, to execute on our pipeline, to tap these big market opportunities and to harness the power of digital, we needed to make some operating and cultural changes. Our new operating model is about empowering our businesses and gaining greater visibility to their end markets. We're now moving at the speed of a startup and implementing incentives that reward market share and growth. We're also changing the culture. This is our time to be bold and add grit into the organization to go along with our mission. And all of this will lead to accelerated growth, which will create a lot of value for our shareholders and provide us at Medtronic with the fuel we need for reinvestment. So our pipeline is here with even more waves of innovation on the way. We have big underpenetrated market opportunities. We're adding a new vector of innovation with digital. And we're changing our operating model and enhancing our culture to ensure we can make all of this a reality. Medtronic is not just leading med tech. We're leading med tech forward. Thank you so much for everything and tuning in today.