Boston Scientific Corporation (BSX) Earnings Call Transcript & Summary

Please welcome to the stage the Vice President of Investor Relations, Lauren Tengler.

Thank you. Welcome, everyone, both here in the room and virtually online. On behalf of Boston Scientific, we want to thank you for joining us today. I hope you enjoyed that video as much as I did. It really highlights how Boston Scientific puts the patient first through the relentless pursuit of innovation. And you're going to hear more about that today. But first, we have some disclaimers to go through. So we will be making forward-looking statements. So typical safe harbor and risk factors apply. Please refer to our latest SEC filings, 10-Qs and 10-Ks for more information. Next we're going to be talking about a lot of different products today, some of which are not available globally. So please refer to this slide for more information. And finally, we have some financial disclaimers. Please note the use of organic and other non-GAAP measures denoted throughout the presentation. Please also note the use of the term LRP, which means long-range plan is in reference to 2022 through 2024. And finally, since our Q2 earnings, we have closed on 2 acquisitions: Farapulse in August, and Lumenis Surgical in September. And now finally, the agenda. So we have a great 4-hour program for you today. You're going to hear from different business unit presidents, Chief Medical Officers, and other leaders about their markets, key products and pipeline over the LRP. We'll also save time for Q&A, and we'll be able to take questions here in the room as well as online. With that, I'd like to turn it over to Mike Mahoney, Chairman and CEO.

Thank you, Lauren. Congratulations again on your promotion, Lauren. Welcome, everyone. It's great to see some familiar faces in person, and hopefully, we have an audience online as well. It's really an exciting day for us. We get to share with you our next 3 years, the next chapter of Boston Scientific. And I can tell you, it's been here for 10 years, and it's absolute privilege and honor to work in the industry and to help our team lead this business globally, which is very exciting. And today, you're going to see, as Lauren mentioned, our high-level strategic plans and really importantly, what embeds all that. The infrastructure and the capabilities of the company. You're going to hear from our business unit leaders and CIOs on the innovation that drives. This is really the heartbeat of the company. And in doing so, you're going to get a flavor for a key part of our business besides the innovation is our people. Many of the leaders of the company -- not all the leaders, but many of the leaders of the company, will show you the depth of our programs and the culture that they bring to work every day, which makes Boston Scientific, I think, uniquely good with a very strong employee engagement. And after it's all said and done, 4 hours later, for those of you in Zoom, that's quite a while, but 4 hours later, hopefully, you will share the same enthusiasm for this company as we all do, not only today, but over the next 3 years and beyond. So I think it will be a great day, and hopefully, you'll get a lot out of it. So I'll start off with our -- just our mission and values, just a few comments. I know you see similar slides with many, many companies. But this really, really is important for our company, advancing science for life. It truly is what motivates us. And you're going to see this with our pipeline, but also you'll see it with the innovation, some of the risk-taking that we have with some of our moonshot portfolio. So advancing science for life to make a real impact beyond the financials, beyond the shareholder returns, which are critical. But really to help patients. And these are the values that we talk about, and the company is quite large. We're in about 130 countries, and each division or region has its own sometimes subculture, which is very natural and that we encourage. But at the end of the day, we really knit the company together across with these values. I won't go through each one of them. But they're also super helpful. And when we have to make difficult decisions and trade-offs, we really put these values forward and carry meaningful ovation, high-performance, global collaboration, diversity and winning spirit. So we bring these values to life every day, and we try to bring the impact that we have on patients right to our employees as much as we possibly can so they can see the impact. So this is a kind of high-level snapshot overview of the company. For those of you who may be less familiar with it, we have -- on the left side, we show the reporting segments, which are Cardiovascular segment, MedSurg and Rhythm and Neuro. You'll hear from MedSurg first, followed by Rhythm and Neuro today and then our Cardiovascular business. On the right side is our geographic split. And there will be less presentations directly today from our European team or our Asia Pac team. But I really want to give a quick shout out to those teams. In Europe, they've consistently grown above marketplace. And we've really, over the last 5, 6 years, laid down more investments in more emerging markets in Europe that are really beginning to drive more benefits. And in Asia Pac, especially in China, despite the onetime DES tender that occurred earlier this year, that business we expect to continue to grow double digits this year and well beyond as it will approach -- when I first joined the company, it was about a $50 million business, and this will approach $1 billion over the LRP period. So an excellent job there. I do want to make a few comments at this point on the third quarter in particular, before we jump into this slide. And I would first start off to say how proud I am of our team's performance and the ability of hospitals really to continue to manage through COVID in this most recent Delta surge. Now in terms of our guidance, recall that our first quarter sales grew 3% organically versus '19, some really big number versus 2020. And that was given the COVID wave that we saw. And in the second quarter, we grew organic 9% versus 2019, with virtually every business growing faster than the peer group. And in that quarter, we had minimal COVID impact, which highlighted the global strength of our business as COVID wanes. So we provided third quarter organic revenue growth guidance of 12% to 14% versus 2020 and 5% to 7% versus 2019, which assumed a manageable level of COVID and similar growth in the second quarter. So over the last 60 days, with the impact from Delta has been more significant in the third quarter than we expected and lasting longer with the U.S. seeing a greater impact than Europe and Asia Pac. So at this time, it's unlikely that we will hit the low end of our sales guidance, organic guidance for third quarter. But we believe it's still possible to hit the full year sales guidance of 6% to 7% organic versus 2019 that we issued on July 27, though we continue to monitor the economic and financial impacts of the recent surge in Delta COVID-19. So we also intend to provide fourth quarter and full year guidance on the earnings call on October 27, when we have more information. So despite some of the softness in the third quarter due to the COVID Delta impact, we continue to see achieving our third quarter EPS guidance of $0.39 to $0.41. And most importantly, we are confident that once Delta wanes, we will return back to stronger than peer growth similar to what we have delivered, driven by our strategy of category leadership, enter into high-growth markets and our tuck-in M&A strategy. So with that, we'll continue on with the program. And I think this is important to see, and you're going to see the benefits of this when you look at our WAMGR. So this is a bit of a historical perspective on Boston Scientific especially for the long-term investor. And I'm really proud of how we've really improved our organic growth profile over the LRP periods over the past 10 years. So when I first joined the company, we were growing flat to negative 1% in the '11 to '13 period. We improved the organic growth profile of the business to about 6% range in that '14 to '16 area. We took another step up in average about 7.3% organic in that 17% and 19% -- I'm sorry, in 2017 and '19 at that 7.3% organic number. And we obviously had some COVID impact quite a bit in 2020 and less so in 2021. So with this slide, and Dan will reinforce this at the end of the presentation, we're guiding towards a 6% to 8% organic CAGR over the '22 to '24 period. On the margin front, we don't go back all the way to 2011, but you've seen a consistent track record of margin improvement up until 2020, when the COVID impact happened. And we'll be guiding towards a greater than 50% basis point margin improvement per year in this '22 to '24 period. And during this time period, we've had a consistent track record of double-digit EPS growth. So I think the important thing here is 2020 has been difficult, '21 less COVID impact than '20, and we see a much brighter future with less COVID impact in '22 and '24. And we've seen the organic growth profile of the company enhanced over each 3-year LRP period. And you'll see the proof of the pudding through these presentations. In doing so, improving margins every year, and in doing so, delivering double-digit EPS growth with stronger free cash flow now than we ever have had since I've been with the company. So over the next 3 years, here's what to expect from the company. Driving growth, obviously, with portfolio innovation. You're going to see a full buffet table of that today through our organization; globalization of the company as we get larger in China in the emerging markets; and many new capabilities, leveraging digital and AI. We are strong believers for many years in category leadership. You saw an acquisition yesterday with Devoro, driving unique innovation in a full portfolio within the service line, we believe, is the winning ticket that drives our above peer group growth. We do this through our organic investments that we make as well as our tuck-in M&A. You'll hear a lot today about digital adoption. And one very positive of COVID is this put this on steroids with many companies as well as Boston Scientific. You can see how we're driving digital capabilities. A very strong commitment to corporate responsibility. This is very much the trend these days, but we were heavily invested in this before it was trendy. And we are well on our way to being carbon neutral ahead of our 2030 guidelines, and I reiterated our financial performance goals just previously, and Dan will reinforce those at the end of the day. This is -- everyone has their favorite slide. This may be mine in the presentation. So I think this reflects the -- our strategy is working over a long period of time and will continue to do so. And I'm really proud of this because it shows in 2011, '12 period, our WAMGR, the markets that we competed in, grew negative 1%. And as we sit here at the end of 2021, I think the market growth is in the 5% to 6% category. And we're quite confident in this LRP period, '22 to '24, that WAMGR actually accelerates to at least plus 6%. And that's through a lot of hard work and strategy and execution over many, many years, many, many quarters of shifting the weighting of our portfolio into faster-growth markets consistently. And you're seeing a -- what used to be a 45% of our portfolio mix back in 2012 was in very low-growth businesses, and a very small amount of 10% were in fast-growing businesses. As we exit '21, you see the numbers. And as you see in 2024, we are confident that over 40% of our business will be in high-growth businesses, with many of those growing faster than 10%. And we've taken that number from 45% down to 15% of our mix of our lower-growth businesses. So this shows that we'll be at a plus 6% WAMGR that we compete in, which is a very, very healthy market, and we'll continue to expect that will drive performance faster than that. This is 1 level deeper. And then during the presentation, you'll see 2 levels deeper in terms of our market segments. This is at the very high level across interventional cardiology all the way through urology. And this breaks down the 6% weighted average market growth rate that we compete in. And you see many of the key product launches that you're going to get a lot of detail on later today. But what I'm really also excited besides these numbers, which you see a couple of things, you see a lot of diversification, instability and a faster-growing market at about 6%. But I won't go through each one of these businesses, but you've seen how many of these businesses really transformed their portfolio strategy and the markets they're in over the years. Interventional cardiology used to be a drug-eluting stent business. Now drug-eluting stents will be half the size of our complex coronary business that you'll hear from Lance Bates, which is a high-growth business, and WATCHMAN clearly is larger than our DES business and structural heart coming. So that business is completely transformed. Peripheral interventions, with all due respect, used to be kind of a sleepy $500 million metal-stent and balloon business. Now it's a fast-growing business, where we're the leaders in arterial, venous and interventional oncology, so really transform the markets that we serve in Interventional oncology. Now it's same thing with urology. It used to be about stones and baskets, about $500 million. I think we had 2 reps in Europe and maybe a part-time assistant in Asia Pac. Now it's very much a global business. We're the global leaders in urology, driving innovation, really setting the pace in that entire field as that approaches a $2 billion business, and they've completely transformed the market CAGR that they compete with. And it's a similar story across some other businesses. But for the sake of time, I'll move on. You'll hear a lot here on -- across our businesses, with thanks to Jodi Eddy and Mary Beth Moynihan in our team, we're really driving many digital capabilities. So clearly, each division has some unique specific digital capabilities that they need. But then we also drive core capabilities in the center of the company that we leverage for productivity. And I won't go through each one of these, but whether it's patient engagement, you'll hear this from Dr. Brian Dunkin and our endoscopy team that's really driving and pushing that as well as our Neuromod team with our EDUCARE programs. Patient engagement. I'm sorry, with the WATCHMAN group on activating patients appropriately and driving the right awareness. And you'll see a lot of leveraging AI across our business, whether it's in our imaging business, whether it's in our urology business with our StoneSmart capabilities, whether it's in our deep brain stimulation business with smart sensing. Or in our EP business with our Preventice acquisition, where they leverage AI capabilities to drive productivity with our extended holter capabilities. And also driving that internally with our quality organization, how do we leverage AI to really take our quality to the next level and driving cost productivity. And obviously, we want to make Boston Scientific easy to work with, as easy as possible for our customers. So big investments across the business here, and you'll see a lot of this tucked in all the different presentations that you see. Sometimes we make Medtech a little bit more complicated. I always believe that the 2 key things here are your leaders and your innovation because lots to get distracted about Medtech. But if you have excellent leaders with a winning spirit, willing to take appropriate risk, can think globally, have the confidence to make decisions and push the business forward with the right pace, that's the winning formula, supported by innovation. And not all the innovation is going to work, but you have to take chances on innovation to have a special company, and I think that's what you have here at Boston Scientific. So as internally, we spend, as you know, about 9% to 10% in R&D, so well over $1 billion in R&D. And that R&D mix has shifted over the years. So our clinical spend within R&D is actually increased as a percent of that total mix each year. And we do that because we need that strong clinical data, not only for the product approvals, but also to drive the appropriate reimbursement in this era that we work in and also give the doctors the confidence that they need. So well over 1/3 of our R&D spend is within the clinical science area. And we also spent a lot of time on our internal R&D assuring that the investments we're making across these are in businesses and opportunities that are growing, that are additive to the growth profile of the company. The second area that we've been very active in and Dan Brennan is going to give you some more flavor on this is just our M&A and tuck-in portfolio. And so we've been pretty active in the M&A area. It all adds up to enhancing that growth profile of the company and supports this category of leadership strategy. You haven't seen us go off and buy a company that's too far outside the core. So usually the acquisitions we make drive greater category leadership and faster innovation within that call point that we cover. And we think that's how hospitals like to contract, and we think that's a winning strategy for us. We've also been very active in our venture portfolio. Almost half of the acquisitions that we've done have come from our venture portfolio, and you saw one yesterday with Devoro. So this is a busy slide, but this is one slide of really what you're going to hear about today on the innovation front. And I won't go through each business here or each product, but this is a one pager you're on what you'll see, the key growth drivers through '22 and '24 on an R&D innovation. And obviously, there's a lot of commercial focus and capabilities that we're not going to drive into in detail in every business. But this is on the innovation front. And then I think what's also important is we want this company to be fantastic well beyond the LRP period. And we have an obligation for the leaders way in the future to make Boston Scientific much better when they receive it than when we received it when we joined the company. And these are some of the key growth drivers that you see in 2024 and beyond. We're investing in many of these today to continue to accelerate the growth profile of the company for the long run. And we also take a shot at these moonshots. So none of these are in our 3-year LRP. Some of them may be in '24 and beyond. But I think it shows a couple of things. I think it shows the winning spirit of the company, willing to take bets and appropriate financial commitments on things that can truly transform patient lives and really change how health care is done. And so you're going to see some of these moonshots. They're not in your 3-year models. They're not in our 6% to 8%. But if a couple of these work, these will be transformative growth drivers for the business and incredibly meaningful for patients. You're going to hear about this from Peter Pattison and Jeff Mirviss on how we're leveraging Y-90 for glioblastoma and Y-90 for prostate, which could be revolutionary. We have a very extensive VC portfolio of about 35 companies that we've leveraged. The greatest assets, I would say we have in the VC portfolio are in the interventional cardiology area. Now we're not going to go through those and disclose many of those, but we are very excited about a number of the significant bets that we have in our VC portfolio to continue to broaden out the WAMGR and enhance that growth profile of cardiovascular. In Neuro, you're going to hear from our -- from a lot of the team on what we're doing with Alzheimer's and stroke recovery with DBS, leverage the capabilities there. And this AXIOS product that we have for Endoscopy, which is a very small tuck-in deal we did years ago has vastly exceeded expectation, not only with the growth that it provides currently, but also with the capabilities that we think might have the chance to really disrupt the gastric bypass capabilities to help obesity with patients, and even leveraging our current platform with diagnostics. So just to wrap this up a bit more before I go into the endoscopy team and introduce Dave Pierce. This is a one-page summary about living our values, how many patients that we treat per year, well over 30 million patients per year. We'll continue to grow that at least 6% to 8% per year and hopefully more. Investing in our people. We're very excited about what we do in our ESG commitments. We expect we'll beat this 2030 carbon-neutral goal that we've put in place based on the excellent work of our operations teams and Brad Sorenson and Ed Mackey in our facilities teams to drive carbon neutrality quicker than 2030. We just recently signed up to this net zero initiative. And to us, that was an easy one. We think it's a terrific initiative. We encourage other companies to jump on this one. It's right in line with our current plans and shows the commitment that we have as a company. And you want us to deliver great innovation and great financials and be super responsible and help with the climate change. And also creating value responsibly. Obviously, we want to drive shareholder returns faster than our peer group. That's the goal. This is a fantastic business. We get to work with a wonderful team, drive innovation, compete with good competitors and ideally win, which is what we do at the company. And I really hope that you'll share the same enthusiasm we have for the company as you see this. And here are a bunch of the leaders that you're going to meet today kind of in 10-minute blocks throughout the day. So I'll come back. We have plenty of time for Q&A during the different segments. So we have about 10 to 15 minutes of Q&A during each segment. And then Dan and I will wrap up at the very end with some additional Q&A. So hopefully, whether you're in-person here or virtually, we have plenty of time to address your questions. And I couldn't be more proud of this team, and I'll turn it over to Dave Pierce, our leader of Endoscopy business. Thank you.

Good morning, everybody. Really happy to be here to kick off the MedSurg portion of our agenda and specifically the Endoscopy business. Really great business for Boston Scientific, and I'm going to be joined today by Dr. Brian Dunkin, who's our Chief Medical Officer for Endoscopy. I think it's very well understood that the Endoscopy division is a consistent growth engine for Boston Scientific. We have a long-term record of high performance, and our growth consistently outpaces the markets that we compete in. It continues to be an exciting growth business with opportunities both in our core and for market development and market expansion. We'll show that we've established clear category leadership, and we'll continue to extend this. Our margins and our growth rate are both accretive to the corporation. And we're targeting revenues of $3 billion by 2025, representing a $1 billion growth over this period. So I'll now hand it over to Brian to take us through the next couple of slides.

Thanks, Dave, and good morning to everybody. We thought it'd be important to take a minute to explain what we mean at Boston Scientific when we say endoscopy. This video animation is an example of endoscopy, a procedure where we pass an endoscope, a flexible tube with a light and camera on the end of it into the patient's body, either into the gastrointestinal tract or into the pulmonary system. This video is showing an example of ERCP, a procedure that we put in our pancreaticobiliary space, where we actually use the GI track to access the bile duct and pancreas duct, which are attached to it. And in this example, you're seeing our mini endoscope, SpyGlass, introduced inside the bile duct to visualize the tumor and to take a sample there. The exciting thing about endoscopy is that it's used in so many areas in the body. So it's used in the pulmonary system, both in the airways and in the lungs. It's used throughout the GI tract from esophagus, stomach, small intestine, colon and rectum and it's used to access organs that are attached to the gastrointestinal tract like the liver and the pancreas. So in the medical community, this gives us an opportunity to use endoscopy to treat many disease states. And for Boston Scientific, it gives us the opportunity to create a large portfolio of devices to serve those disease states. And I'll have to say I'm a surgeon and a therapeutic endoscopist by background. And one of the exciting things that I've lived through and continue to live through in surgery is the migration of surgical procedures over to endoscopic procedures. And we're going to show you some examples of that a little later in the presentation, but that truly is the forefront of minimally invasive surgery, endoluminal surgery. So when we talk about endoscopy, that's how we define it. Dave?

So there are 5 key markets that we serve, and we estimate that they're valued today at about $5 billion, growing at 6% through 2024. And I'll highlight 2 for you this morning. First is pancreaticobiliary. This is the foundational market for our business. We value it at $1.6 billion. It's growing at a solid 7%. And for context, pancreatic cancer is a fourth leading cause of cancer death in the U.S., and our products assist in the diagnosis and treatment of this. I'll also point you to gastrointestinal bleeding, a $700 million market, growing at a strong 8%. And this is a market that we've really developed. Managing GI bleeds is one of the most stressful challenges that our customers deal with. In fact, there's a 10% mortality rate associated with upper and lower GI bleeds. Two keys to our strategy are strengthening category leadership and expanding into new markets. And we do this in 2 ways: first, with our portfolio. We have the broadest and deepest portfolio in the space, and we'll continue to develop and expand our biliary and GI therapies while expanding into new markets such as single-use imaging, endoluminal surgery, infection prevention along with pathology and services. In addition, while the gastroenterologists remains our primary focus, our products are now able to have a role with additional specialties such as clinical -- I'm sorry, critical care, pulmonology, interventional radiology and surgery. The markets that we compete in are listed on the left-hand side of this slide. We're excited because we have key accelerators in every one of these markets. For example, in pancreatic biliary, we're very bullish on endoscopic ultrasound. We've already established leadership with our needle portfolio and with the AXIOS platform, and you'll hear a lot from Brian on the AXIOS platform later. And we'll continue to invest to lead in this emerging and fast-growing segment in the pancreatic biliary market. In the gastrointestinal bleeding market, we have led the development of hemostasis devices with a long-term record of innovation with our resolution clip family, and we'll continue the innovation journey and enter the nascent hemostatic agent space. This technology that we're working on and that we'll ultimately bring to market will accelerate the adoption of these agents, which complement the devices and will enhance our customers' ability to treat these difficult cases. And lastly, in pulmonary, we're super excited to be launching our EXALT Model B single-use broncoscope. We designed the scope to provide excellent visualization and maximized suction. Early clinical feedback has been extremely positive, and Dr. Dunkin will provide detail on this as well. I stated earlier that we have established clear category leadership, and we do this through our comprehensive go-to-market strategy that we deploy globally. It starts with the broadest and most innovative product portfolio. This is the foundation. But we augment this with best-in-class clinical and economic evidence to support adoption. We've increased our focus on physician education and training, investing in people, resources and new capabilities. And we're leveraging the science of education to enhance procedural adoption. The capabilities that we developed and deployed during the pandemic allow us to extend our training reach more broadly. Our commercial team is the best trained in our space. We spend a lot of time and effort to ensure that they are both clinically astute and have solid business acumen. And in addition to innovative products, we bring solutions and services into the market, the best note of which is our GI-focused pathology business. Our health economics and market access capabilities are best-in-class and they support the development and practice of endoscopy worldwide. This team works hard in partnership with multiple external constituents to ensure that our technologies get the appropriate reimbursement that is needed. For example, securing Medicare and Medicaid coverage for EXALT-D is one specific example of the excellent work that this team does. And then lastly, our commercial contracting team bundles all of this and works with key economic customers around the globe to develop committed programs that provide value on both sides of the table.

So Dave and Mike both talked about how we grow our organization by expanding into new markets. I would say that we actually have created those markets in a number of instances. And I want to share 2 of them with you. One is around AXIOS, and the other is around single-use imaging. So let's talk about AXIOS for a moment. On the face of it, AXIOS kind of looks like other stents, a round woven material in a tubular structure with some covering on it. But when you really understand what AXIOS is, it's a revolutionary device. It's an anastomotic device. What's an anastomosis? Well, again, in surgery, when I create an anastomosis, that's a connection between 1 part of the body to another. AXIOS allows us to make that kind of a connection with an anastomosis, using an endoscopic technique. Now let me give you an example. You see on the slide here, pancreatic fluid collections. Pancreatitis is a severe inflammation of the pancreas that can lead to fluid collecting around the pancreas that becomes infected. And that fluid sits behind the stomach. Before we had AXIOS, if I was treating a patient with that disease, I had to take them the surgery. In fact, I would have to take them to multiple open surgeries to drain that fluid in the debris that was part of it. AXIOS allows us to endoscopically connect the stomach to that fluid collection and drain it internally, completely changing the care pathway for these patients. And when you begin to think of AXIOS is that a nastomotic device, now you can see how we can not only grow it for applications like pancreatitis but expand it into other areas. And you heard about one of those in the moonshot description that Mike gave in metabolics. If I can connect the stomach to the small intestine further downstream bypassing some of that small intestine, that potentially has a metabolic effect on that patient that could help treat the complications of obesity like diabetes and fatty liver disease. Now let's talk about single-use imaging as another example of creating a market and then expanding into it. As you know, we've developed quite a portfolio of single-use imaging devices in endoscopy. And we're not new to this area by any means. In fact, we introduced SpyGlass DS, the world's first single-use cholangioscope to the endoscopy market 14 years ago. And it was transformative. Prior to SpyGlass, if you were an endoscopist that wanted to be able to see inside the bile duct or inside the pancreatic duct -- That was a difficult proposition. The technology wasn't typically available. The expertise wasn't available as well. And so very few places we're able to do that. SpyGlass DS changed all of that. Now it's become standard in ERCP to be able to grab SpyGlass off the shelf at the ready when needed and introduce it into the biliary or pancreas duct. And that's the mini endoscope that you saw in the video that I showed, visualizing that tumor in the bioduct and allowing us to do a targeted biopsy. EXALT Model D, the world's first single-use duodenoscope we introduced into the endoscopy community in 2020. This was a scope to help mitigate a very difficult problem. Duodenoscopes are one of the most complex that we use, the scopes that are used for ERCP, again, what I showed in that video, and they're very difficult to clean. And in fact, 1 in 20 duodenoscopes that has been cleaned using best practice and thought to be patient-ready is harboring pathogenic bacteria, bacteria that can cause illness in that patient. So we leveraged our experience in single-use imaging and said, let's bring a single-use duodenoscope to the market, mitigate the problem of infections from reprocessing. And this is revolutionary. Now as a clinician, I get a brand-new scope every time for every patient. And as a patient, I get a sterile scope that's never been used in another patient. It's revolutionizing ERCP. Expanding in the single-use imaging category, we've done release SpyGlass Discover later in 2020. This is an endoscope that's optimized to be used by surgeons and interventional radiologists so that they can see inside the bile and the pancreas ducts. And it's already transforming how patients are being cared for by these specialists. It's introducing these specialists to the power of endoscopy and how they can improve their patient care using that. And I have to say it's been extremely gratifying to see interventional radiologists trained to use SpyGlass Discover, go back to their interventional radiology suite and take care of patients that were told you don't have an option. You have a complex disease that requires permanent drainage, you're going to have to live with that drain for the rest of your life. They're getting those drains out in those patients and changing the patient care pathway, truly revolutionary. If you go to an IR conference today, they're talking about cholangioscopy. It's one of the hottest things they're discussing. And finally, EXALT Model B, as you heard, released earlier this year. This is our single-use bronchoscope optimized for best visualization and superior suction. And while suction can sound kind of mundane, when you're doing the bronchoscopic procedure, with the purpose of clearing secretions from the lung so that patient can breathe better, suction is everything. It's why you're doing the procedure in the first place. So it's been exciting to see the initial clinical response around this device, and this is harnessing a move in the bronchoscopy area that already was taking place even prior to COVID. And that's a move away from reusable devices to single-use bronchoscopes, and we're seeing it in FDA guidance, and we're seeing it in some of the guidelines from the bronchoscopic societies themselves. So AXIOS and single-use imaging, examples of creating new markets and then growing them. Dave?

Great. Thanks. I'd like to just provide a little bit more color on single-use imaging. First and foremost, it remains a key part of our growth story. It complements our current and planned device portfolio and allows us access into large and growing adjacent markets. Imaging categories that we presented here today represent a $2 billion total addressable market. SpyGlass cholangioscope, as Brian says, the established standard of care in this category, and it delivered strong double-digit year-over-year growth and continues to add to its widespread adoption globally with over 2,500 controllers installed worldwide. EXALT-D continues to be a significant market opportunity for us, and it has been impacted by the challenges associated with COVID. And despite this, we're delivering strong quarter-over-quarter growth by expanding installed accounts, and we're seeing solid reorder rates. And we plan to introduce EXALT-D version 1.5 this month, providing improved handle function and ergonomics. And with over 1.5 million ERCPs completed annually, and the known risks associated with cleaning reusable scopes, this is a long-term market opportunity for us. SpyGlass Discover, new category, as Brian said, super excited about the ability to access new call points. The early clinical feedback has been fantastic, and the early adoption of reorder rates have been very encouraging as well. And then lastly, our single-use bronchoscopy scope is entering into a market that's already at $300 million and will continue to grow given that there's 3 million bedside bronchoscopy procedures completed annually. You heard from Brian, we designed this scope to address physician needs. And the early feedback that we've gotten out of Europe as well as the U.S. has been fantastic, and we will gain meaningful share in this growing segment. So in closing, you've seen that Endoscopy has been and will continue to be a big diversified global business delivering profitable growth for many years. We have the strategy and the execution plan to take this business to $3 billion in 2025. So with that, I'll thank you for your time this morning and introduce Meghan Scanlon to represent our Urology business. Meghan ?

Thanks, Dave. Well, good morning, everyone. My name is Meghan Scanlon. I am the President of the Urology and Pelvic Health division, and it is my honor to serve an amazing team across the globe as well as a pretty dynamic and exciting market, to really lead a business that ultimately has been and continues to be one of the fastest and most profitable growth drivers within the Boston Scientific portfolio of divisions. We are the clear category leader in urology across the globe. And we have demonstrated high performance and strong global commercial execution in serving a very dynamic and actively growing urology marketplace. One of the nice pieces about this business, both the story to where we are today and the story that lies ahead is our sources of growth and innovation come from organic innovation, come from really smart, well-executed tuck-ins and a continued significant runway in global expansion. Now this business for Boston Scientific contributes accretive top line and bottom line growth rates as well as accretive margins. And we aim to eclipse that $2 billion mark by 2023. So I mentioned, we serve a really dynamic and exciting marketplace. Today, the market is estimated to be $4 billion. And in the long range -- in the LRP, we expect it to grow approximately 8%. Now let's start with stone, right? So kidney stones are the largest market, growing approximately 7%, and it also happens to be the largest part of our business. Now fun fact, 12% of the human population will be impacted by kidney stones at some point in their life. And if you've ever known somebody who has suffered from kidney stones, it has been described as being more painful than giving childbirth without epidural support. It's a very big, very growing market with a host of unmet needs and a patient demand that is outstripping hospitals capacities to be able to serve them. So that is a ripe opportunity for innovation. We're excited to share with you how we're going to approach that today. Second, and this is our fastest-growing market in prostate health, estimated to be growing today approximately 15%. And this is for BPH and prostate cancer. Now 50% of you men out there once you reach the age of 50, half of you have a chance of suffering BPH. And we have a host, a portfolio of solutions that Shashwat will talk about in a couple of coming slides. And unfortunately, we also know that 1 in 8 men, just in the United States alone, are going to be diagnosed with prostate cancer in their lifetime. And Boston Scientific and the medical community continue to make meaningful advances to make treating this prostate cancer safer and more efficacious. Now let me pivot your attention to prosthetic urology. Prosthetic urology is the market where we serve men who are suffering from erectile dysfunction and urinary incontinence. Now while on the surface, occasionally, that might get some giggles. In all seriousness, these conditions do so much to negatively impact the quality of life of men around the world. And it probably has one of the most meaningful impacts on their sense of self and human dignity. And we have technologies that ultimately can be curative for these patients around the globe. Now in the United States alone, 22 million men suffer from ED. And not just moderate to severe ED, there's many, many more men who are on this spectrum somewhat. So today, we see a market that's growing in the mid-single digits. But our conviction is that we can bring innovation to unleash further market growth and market acceleration for these patients, so we can treat more of them around the world. And then lastly, we have a small pelvic floor marketplace that's pretty flat that helps women with stress urinary incontinence. So you get a chance and you have an opportunity to see the very dynamic market we serve. There is a host of unmet needs, where we have opportunity and runway to grow, expand our reach across the globe as well as continue to drive growth here in the United States. All right. So Mike had mentioned urology and pelvic health, right? Back in 2014, we were a small and wonderful kidney stone business. That was around $500 million. We had earned a category leadership position in this marketplace. And if you look at the -- as the years have gone on, that business as well as some really smart tuck-in acquisitions has built a very stable, solid, robust market-leading foundation against which we have been now able to enter into really wonderful growth accelerators, high-powered pulsed lasers in urology that help with kidney stones and BPH therapy. I'll talk in the next slide about the Lumenis acquisition, which we closed on September 1. LithoVue, right? Dave and Dr. Dunkin just talked about disposable scopes. LithoVue was the first of its kind, organic innovation that came from the Boston Scientific brilliant engineers that established this market category and continues to be a significant double-digit growth driver for us. Now here we are 6 years after launch. And then we had the really wonderful tuck-in acquisitions of Rezum and SpaceOAR that built out our prostate health portfolio. And those technologies have been and will continue to be meaningful double-digit growth drivers to be able to treat and activate more men around the world to seek the care that they deserve. So our approach to growth, and you see these accelerators showcased here in TL, has been wonderful mix, again, of organic and acquired innovations. So speaking of meaningful innovations and category leadership, let me pivot you to the Lumenis acquisition, which we closed just a couple of weeks ago on September 1, where we were delighted to add a very meaningful urology laser portfolio to our urology broad-based portfolio. And as importantly, welcome a very talented team of individuals to the Boston Scientific family. Now there are 3 major kind of strategy and value drivers of this acquisition. First, category leadership, right? I've already established, we are the clear category leader in urology across the globe. And Lumenis Surgical had earned and established and maintained a strong category leadership position in neurological lasers around the world. This is a beautiful and perfect marriage. And with this acquisition comes a great and broad portfolio of lasers that allow us to serve now multiple different customer segments in different regions across the world as well as different sites of care, whether it be hospitals or ASCs or outpatient centers. So we're excited at the portfolio that's been added to the Boston Scientific family of products. And then lastly, and we talk about financials. This is an acquisition that is accretive both in growth, top and bottom line and adjusted earnings per share for Boston Scientific. And I can confirm today that the business is on track to deliver $200 million of total revenues in 2021. Now the advantages of this acquisition don't stop there. We are excited at the portfolio of innovations that are going to be coming out of our new laser center of excellence located in Yokneam, Israel, which I'm excited to visit next week, where we are looking at future waveform innovations to continue to strengthen how kidney stones and BPH can be treated around the world, connectivity enhancements and artificial intelligence. Two approaches that are very consistent with the way we have been thinking about unleashing capacity and capability in StoneSmart -- with StoneSmart, which is the way we're going to try to transform the way kidney stones are treated around the world. And so to talk more about that, I'd like to introduce and welcome to the stage Mr. Shashwat Bennur. He is our Global Vice President of Marketing for Urology and Pelvic Health.

Thank you, Meghan. Thanks for the intro. All right. I am excited to be here to share with you the very important markets we play in as urology and pelvic health. I'm going to start with kidney stone management that Meghan touched upon. And this makes for a large annual market for us to address of over $2.5 billion, as you can see on the chevron on the left-hand side there. Given that this space helps treat conditions that are acute and symptomatic, the business for us has proven to be incredibly resilient as we navigate the pandemic. And another key dynamic in this market is the widening gap between the demand for surgical procedures vis-a-vis the number of urologists in practice. And to help make up for this gap, our physician customers ask us for innovations that enhance procedural efficiency. So how do we go about doing that? And to talk about that, I'm going to move to the right-hand side of the slide to address our market position and our portfolio. And first off, kidney stone management is the largest and most global franchise for urology and pelvic health, not only that, it's actually one of the largest franchises for BSX. We are #1 by a long margin in this market. And we believe that we have earned the right to move the market to the next level of innovation here. And when we reflect on what it is we're doing, we're actually creating a new category. We are calling it Intelligent Intrarenal Surgery, and we are powering that with what Meghan talked about, which is StoneSmart, the StoneSmart suite of solutions. And as we've discussed before, LithoVue Elite is a key component of our StoneSmart solution suite. And again, you got to keep in mind, that is a part of the intelligent interrenal surgery space that we are creating. And to think about what is intelligent international surgery, it is when you take individual stand-alone physical products, connect them with the power of artificial intelligence and have that connected ecosystem drive greater procedural efficiency for our physicians during kidney stone removal. So to show you some cool stuff under the hood of how we are innovating with LithoVue, how we're bringing the next generation of innovation, I'd like to take you live to our immersion lab based in Marlborough with Adam and Tegan.

Thanks, Shashwat. Welcome to the new Boston Scientific Immersion Lab, where we connect virtually with physicians from around the world.

During the removal of kidney stones, current ureter scopes do not provide real-time intrarenal pressures of the fluids that are needed to maintain clear visualization. And elevated pressures may result in pain, kidney damage and even sepsis.

Our next-generation LithoVue Elite ureteroscope includes a tiny pressure sensor embedded into the tip of the scope without increasing the scope size. You can see this tiny sensor is actually smaller than the L in Liberty on this penny. Using a model of a kidney, a commonly used fluid delivery device and the embedded sensor, we can monitor fluid pressures, enabling physicians to make pressure-related decisions.

We have also focused on image quality with updated imaging hardware, new proprietary software and image processing algorithms. Using this miniature model, I can show you the different characteristics of images with side-by-side views of the current and new scopes. And as I move around, you can see differences in clarity, color, brightness and depth of field.

Thanks for taking a tour of our immersion lab.

You can see how this virtual interaction helps us advance science for life. Back to you, Shashwat.

Thank you, Adam and Tegan. Just to reiterate what you just saw is going to be the world's first intrarenal pressure scope, which, oh, by the way, also happens to be a single-use scope. I'm thrilled to inform you that as we speak here today, our teams are getting ready to submit for de novo approval here in the U.S. and also for approval in Canada. And to conclude on this market here, interesting factoid. Single-use scopes are currently used in about 15%, 20% of all ureteroscopies. And by bringing innovation like the ones that you just saw here, we are going to change the game. And like Meghan said, 6 years ago, after we launched the single-use scope category, LithoVue continues to be a significant double-digit growth driver for us. Case in point, it took us 40 months, 4-0, to hit the first 100,000 patients. 18 months, so less than half that time to hit our second 100,000 patients. And we are well on the way to getting our 300,000th patient in the next couple of months in a fraction of that 18 months through the pandemic. This is to say is an incredible runway of growth in this market. And that's what I have for kidney stone management. Let's move to our prostate health business. I'm starting on the left-hand side of the slide, what I am and what the team is most excited about in this market is the incredible untapped market potential with over 8 million patients between benign prostate hyperplasia and prostate cancer spacing. And that makes for a $3.5 billion annual addressable market for us to penetrate. Referencing BPH on the left-hand side there. We've said this before and, again, with conviction. This market is way more than a 2-player zero-sum winner-take-all game. We've taken a portfolio view in a growing market. And just with the portfolio that we have now in 2021, by the end of 2021, we would have treated 140,000 patients. On prostate cancer spacing with SpaceOAR, looking at the picture on the right-hand side, the man on the right-hand side there. There's over 1 million men that are diagnosed with prostate cancer annually, 1.2 million, about half of whom undergo radiotherapy for the prostate and 60,000 of them benefit from prostate cancer spacing solutions with SpaceOAR. So again, incredible headroom there for us to grow. So how are we going to win? Moving to the right-hand side of the slide, there are 3 things that help us shape our strategy, right? Clear and compelling evidence, the speed at which we reach more patients globally and unleashing the power of our portfolio. So on a clinical evidence front, Rezum Water Vapor Therapy for the prostate has the lowest 5-year surgical retreatment rate of 4.4%. And based on fantastic data like that, Rezum is gaining steam, pun intended, as a national alternative to surgery and one that definitively -- this is important, one that definitively treats the underlying condition. On the prostate cancer spacing side of the house, I mean, SpaceOAR remains the only and most studied -- this is important, the most studied prostate spacing solution ever. And we have more than 100 publications to speak for its safety and its efficacy. Our global expansion plans remain on track. In fact, we leverage the pandemic, and we leverage technology, too, to train physicians in China on Rezum with 100% remote, 100% virtual support. And on the aegis of the Chinese government, we are well into treating patients in China through an innovative pilot program. So we've dropped our pin in China. We are first there. We continue to accelerate innovation. We are now in the full launch phase of SpaceOAR Vue, which is the only CT visible spacer in the market, allowing physicians to plan their cases better and potentially eliminate an added MRI, thereby increasing practice efficiency. We expect Vue to account for nearly 50% of all SpaceOAR units in 2021, firmly on the path of making CT visibility the gold standard of care for prostate cancer spacing. So that's the excitement I want to share with you on prostate health. Let's go over to prosthetic urology quickly. All right. So I'm going to start on the left-hand side of the slide. Similar to prostate health, we have a massive opportunity to increase market penetration here. Like Meghan was saying, in the erectile restoration market, just in the U.S., there are 22 million men that suffer from moderate to severe erectile dysfunction, 7 million of whom have tried drugs. Our data shows us that 3 million are actively looking for alternatives. And there is 1 million men in the bull's eye of the solutions that we provide that could benefit from this therapy and the market has about 20,000 to 25,000 units to show for. So said another way, in the erectile restoration market, a 1 percentage point increase in penetration yields about 10,000 patients and $140 million, $150 million in incremental market revenue for us to take. So how are we going to continue to grow in this space and set the stage for radical innovation? Moving to the purple sector, the middle of the slide there, in the short term, we will continue to deliver meaningful portfolio enhancements that will enable us to continue to extend our global leadership and drive brand loyalty. We are going to continue to leverage data. We have developed this capability, I think, like Mike was mentioning through the pandemic. And now we are able to smartly generate hundreds more leads every month. And coming out of the pandemic, many of these are going to translate to additional implants for us. Finally, on the right-hand side of the slide, I'm calling out that we're investing significant R&D dollars in revolutionizing the ER market, the erectile restoration market. We are underway in a collaborative project, the way only Boston Scientific can. We're actually working with our colleagues, our teammates from Neuromodulation, our teammates from Rhythm Management and our R&D centers of excellence, both here in the U.S. as well as in Ireland to bring this radical innovation into the market. We expect to deliver that, exactly that, to the market in a few years beyond the LRP and enable more men in the bull's eye of the solutions that we provide to benefit from this life-altering therapy. So that's all I have from the brilliant franchises that we have at Europe PH, and I'm handing it back over to Meghan.

Thank you, Shashwat. And I'm just going to end where we started, which is this is one of the hidden gems systems inside the Boston Scientific portfolio. This is a dynamic and fast-growing business, serving a dynamic and fast-growing market. where we bring top and bottom line growth and margin to Boston Scientific, which are accretive. And with that, I'm going to turn it back to Lauren, and we're going to tackle some MedSurg Q&A.

Great. Thank you, Meghan. We're going to open up the next 15 minutes for Q&A. So thank you, team Endo, for coming back to the stage.

We'll take questions in the room and online, and I have some questions online, but we'll start in the room. [Operator Instructions] And please go ahead, Matt.

Is it on?

Yes.

Robbie Marcus, JPMorgan. Thanks for a great day, and I really appreciate the presentations. Really just one question here. Disposable scopes go across both businesses have been a big driver of growth in the past. I imagine a big component of the $3 billion in endoscopy sales, $2 billion in urology sales you forecast in the future. Can you give us a sense of where disposable scope stand as total sales across the 2 divisions today? And what your disposable scope growth might look? As I imagine, it's a big part of the growth drivers, and I think would be really helpful.

Yes. Thanks, Robbie. I'm not going to give you a specific number as far as revenue from disposable scopes for Endo or Uro. Suffice to say that it's an increasing part of our revenue. And I think you have to look at the categories. Shashwat mentioned kind of the journey from 100,000 to 200,000 to 300,000. So LithoVue was a market development initiative and it's going great. I look at the same way for EXALT-D. It's a market development. We think over time, it's going to continue to grow and maybe be on the same trajectory. If you look at the bronchoscope, it's an established market with tons of room to grow. So that's a market share game for us, and we think we have the right tool to go in and take demonstrable share there. I don't know, Meghan, if you want to.

I think that's well said.

All right. Next question.

It's Matt Miksic from Crédit Suisse. A follow-up on the disposable scopes, EXALT-D and EXALT-B. If you could talk maybe a little bit about this cadence that you've mentioned with LithoVue, how long it took to get to the first number of accounts and how long it took for the second group of accounts? And is that a sort of metric that we should be thinking about for '21, '22, '23 for some of these disposable scope platforms?

Yes. Again, thanks, Matt. What I would say is it's kind of a tale of 2 cities. B has an existing $300 million marketplace. We're bringing a better tool into that market. We're going to go grab share and continue to develop that market. There's 3 million bedside bronxs done annually, and we're just scratching the surface there. On D, I think it's going to be a similar trajectory. What we're excited about from a D standpoint is knocking down the barriers. We've got full Medicare and Medicaid reimbursement coming into place starting October 1. And Brian, maybe you can talk about some of the clinical applications. We're going to see some publications with clinical adoption algorithms coming out in the fourth quarter and into the first quarter of next year. And so we believe that as these things get knocked down, reimbursement becomes more clear, clinical applications become more clear, you'll see that growth.

I would just add to that. I think, again, the different scopes are going to be a little bit different. So EXALT-D in that comparison with LithoVue. Now if you look at LithoVue from a clinical standpoint, it started with the urologist figuring out where should I use it? What's the best case is. Kind of became an inventory protection thing. I want to use in those difficult cases where I'm destroying my reusable scope. And then once you kind of got that into the unit, and they got familiar with the technology, expanded from there in the way that Shashwat described. I see EXALT-D, the same thing. I think COVID has slowed down that understanding of, hey, where do you apply this and which patients. But we're now starting to see -- they'll be in print soon publications on here's our algorithm, here's where you apply it. This is where it's clearly effective and it will follow similar. Different from, say, Spy Discover, which I mean there's like this profitable excitement in the interventional radiology space. It's not a big barrier for them to learn how to use the technology. The difficult part of the procedure is getting access percutaneously to the bile duct, and they are experts in that already. That's not a big deal. And they're excited to be able to do direct visualization and then manage diseases. So that -- the IR community is banging down the door to say, this is a new thing. And the surgical community has already -- they're shifting back to kind of taking some ownership of the bile duct again. Now because logistically, it's just not all the burdens of having to find a scope in order to do a common [ bilic ] expression. So that might follow more like Spy DS did, for instance, in the ERCP space. Does that help?

Yes.

All right. Great. Another question to both Endo and Uro. How are you considering robotics as it pertains to your businesses?

Yes, I'm happy to take that. It's an important question. I would say that it's probably no surprise that we are hypervigilant about the robotics space and understanding what's happening there, both from what's commercially available and what's in development. Our approach to robotics has really been to take a careful look at, well what does robotics bring to a procedure and deconstruct robotics into its essential elements. And you can think of some of those things, navigation, augmented reality, target manipulation, stabilization, those kinds of things. And then to take that kind of portfolio of capabilities and map it against the disease process that we think that robotics may have an indication for. And when you do that, you are able to come up with kind of a more appropriate envelope of technology that is brought together in a systematic way. And I'll give you 2 examples. One, in lung nodules and lung cancer and one actually in stone disease for renal stone disease. So you think about in the lung space where we're seeing robotics, that's a lot of technology and a lot of computational power being brought to bear to make sure that I am confident my needle is getting into this small target. Next year, we're going to be releasing INOD on to the market. INOD is the world's first single-use disposable ultrasound-guided biopsy needle for the lung space. And so now INOD can do what the robots can't do. I can, as a clinician, watch my needle under real-time ultrasound guidance go into my lesion. So when INOD's there, do you use it with your robot? Well, maybe you want to. Maybe we hope -- we anticipate that it will be compatible with robotic platform. So if you're a robot person, you can use it through your robot, but we're not so sure you need a robot. And I would say when you saw the StoneSmart suite for managing kidney disease or kidney stone disease, that's a perfect example of taking technology that has stand-alone capabilities and value and bringing them together as a system to optimize treatment in an efficient and effective way. And so it's the appropriate envelope of technology brought together with computational power with the right kind of capital footprint.

Yes. Like the lower burden capital footprint for an ecosystem like StoneSmart is a very important piece. If you really want to treat more kidney stones in outpatient settings and ambulatory surgery centers, where the capital outlay typically contend to be a bit more constrained.

Thank you. One more online before we go back to the room. So this question is from Robert Walker with Redline. How exactly are you innovating in erectile restoration? There has been no innovation for years. And he wants to hear more about where those improvements are being made.

Yes. I mean, suffice to say, I mean, I can't give you all the details in this forum, but suffice to say that it's not an incremental innovation. We are looking to change the way the implant procedure is done, and we are going to bring -- again, we're working with our cardiac rhythm as well as our neuromodulation folks. So that probably gives you a bit of a hint of where we're headed. Yes, it's going to be the era of active implantables.

And I will say in advance of that, we also have a number of smart innovations to make the current patient experience with today's devices a much more enjoyable one. And then transform the patient experience completely with the innovation that Shashwat speaks of. But as you can understand, given the sort of future orientation of that, we don't want to share that competitive intel with too much detail at this point.

Thank you. All right. Do we have any questions in the room?

Matt O'Brien, Piper Sandler. I'm sorry to keep going down the path of EXALT-D here, but it's obviously really important. You've done really well with SpyGlass. EXALT-B is exciting, but it's a smaller market. So you really need to grow EXALT-D dramatically over the next several years. I think to get to that $3 billion number that you are talking about. And my math, and of course, I don't have perfect numbers, it's like a $400 million product by 2025 to get there from maybe around $50 million today. So are those numbers kind of in the ballpark? And then again, I know you've got reimbursement behind you now, but how do we get from $50 million up to $400 million and have that confidence you can do that -- to really grow that business? And then I have a follow-up for Meghan.

Yes. No, that's a fair question. I won't necessarily comment on the numbers of the range. I will say, that getting to $3 billion is not solely dependent on executing with EXALT-D. We certainly intend to execute with EXALT-D. But you saw the depth and breadth of our portfolio. We have a lot of things happening, and we have a lot of things that will support that $1 billion growth. That being said, I think with D, we will do the work that needs to be done. We're already starting to see great work on reimbursement domestically. We're seeing really good private payer wins as well. So that barrier is coming down. You'll see kind of the adoption protocol come out over the next 2 quarters where we'll be very clear on where a physician, where a hospital, should pull D. And we'll continue to iterate and make the scope easier to use. And all of those factors combined will show growth in the over time, and we're confident that we're going to be able to do it.

I also think there's a bit of a critical mass among clinicians, right? It's 1 thing to read the multiple publications that we've put out around the utility of EXALT and being able to use it for any ERCP. It's another deal to get that experience from your colleague who's using it and the confidence that, hey, I really can't do any case with it. And I think we're seeing that in the clinical community as well.

A quick follow-up for Meghan. There's a big proposed cut to Rezum that's out there right now. And I'm just curious about the activity from Boston and clinicians in response to that cut. And kind of where you stand as far as where you think things may play out here over the next couple of months in terms of Rezum and the proposed cuts that are out there?

I'm actually going to let Shashwat take that one. So...

Yes, sure. So first of all, I mean, it's a proposal, right? And through the comment period of September 13, our healthy economics, government affairs teams have actively engaged CMS, both through comments as well as through in-person or active meetings with them to express that we disagree with the proposed office-based reimbursement cuts. And again, it's not Rezum alone. It's going to impact about 600 office space procedures. So we're trying to understand and make sure that the implications of that, which potentially would be moving procedures to hire sites of care may inadvertently happen. So we remain optimistic that the CMS is going to take this into account and correct it, rectify it for the final ruling.

And I'd like to layer on, I think when we look at Rezum, we are seeing such explosive growth rates happening in markets also outside of the United States. And a big part of our future growth journey is around globalization of that technology, where you don't have the reimbursement disadvantages that we deal with here in the United States. And where reimbursement is a neutral condition, we are winning. And we are starting to see -- Shashwat shared putting our pin down in the market in China, we're seeing a real gravitation to the durability, to the speed of the procedure and to the -- and really, right, we're talking this is a less expensive procedure that delivers durable results. And that -- we will bet on that horse long term any day.

Thank you. All right. Last one goes to Jayson.

Just a quick follow-up on...

Jayson Bedford, Raymond James.

Just a quick follow-up on Rezum. How much of the business is international? And what does it mean dropping the Rezum pin in China? What do you have from a regulatory standpoint? Is it unencumbered access? Or are there still hurdles?

I don't know that we want to share the global mix for Rezum.

We've said majority U.S.

Yes. It's still majority U.S. I think that today, that remains true. And then from a globalization perspective with Rezum, do you want to talk a little bit about that?

Yes. It's when I say drop in the pin. It's actually an innovative pilot program that we work with the Chinese government to bring into fruition. So through that, we are treating patients, and we are collecting clinical data as well that, again, I don't want to speculate, but that has the potential of accelerating market access to Mainland China over the -- yes, we'll keep you posted over the coming months.

But is there a formal regulatory approval still coming that would give you broader access?

Yes, it will come. Yes, within our LRP for sure.

All right. That concludes our MedSurg Q&A. Please come back here for 9:55. We are going to take a short break. This is your only break. So make your plans. So thank you very much. [Break]

All right. Please take your seats. I'm going to start up again. And for those of you who have asked, we will be posting slides at the conclusion of today's event. With that, I'd like to welcome to the stage, Scott Olson, President of Rhythm Management.

Great. Thank you, Lauren. Good morning, everybody. My name is Scott Olson, and I am President of the Rhythm Management business here at Boston Scientific. Today, I'll be joined by Dr. Ken Stein, our Chief Medical Officer for Rhythm Management. And joining us for Q&A will be Mark Bickel. Mark is the VP and Controller for our RM business. I am proud to represent a team in RM that is passionate, committed and focused on winning. We compete in a highly concentrated, very large market with share upside. Our growth will be on the back of a highly innovated -- innovative EP and diagnostics portfolio. Our CRM offering will be -- will continue to be differentiated with HeartLogic and EMBLEM S-ICD. And we will drive to a $3 billion business in 2024 and improve our operating margin as we grow and gain scale in our higher-growth businesses. For reporting purposes, we break our RM business into 2 segments: cardiac rhythm management and electrophysiology. Within the CRM business, we run 2 franchises, diagnostics and services, comprising of our Preventice technology and our LUX-Dx offering, a 2-plus billion dollar market and growing. And our core CRM business, which competes in a nearly $9 billion market. In both, we believe we have clear advantages and differentiation. Our BodyGuardian wearable technologies supported by leading AI algorithms. Our LUX-Dx platform offering superior ECG quality and remote programming. And our core CRM bag provides customers and their patients the benefits of HeartLogic and S-ICD technologies. We also believe the synergies and cumulative effect of our CRM sales organization coupled with the Preventice field team offers expertise and scale to drive increased share across these franchises. Now in EP, we compete in a $6-plus billion market, growing low double digits. And we have made great strides in this portfolio, gaining EU and Japan approval for a stable $0.04 in catheter and launching our cryoablation technology of POLARx in Europe. We have gained POLARx approval in Japan as well, and we will be launching in the coming weeks. Our Cryo IDE, FROZEN-AF has completed enrollment, and we anticipate U.S. approval for our POLARx system in the second half of 2023. The NEwTON trial for our StablePoint force sensing catheter has recently begun in the U.S. as well. Recently, we completed our acquisition of Farapulse, a PFA technology for treating AF that we believe has great promise and clear benefits for doctors and their patients. Ken will spend more time on the Farapulse technology in his presentation. Our drive in RM is to create a more balanced portfolio, focusing on big markets with differentiated technology to grow. To achieve our goal of $3 billion in 2024, we will shift our revenue mix from largely core CRM to more balanced businesses in higher-growth markets of EP and Diagnostics. That said, we will maintain investments focused on our next-generation CRM platform to drive further share in that $9 billion global market. And we will achieve this goal of $3 billion in 2024 by continuing to drive our current advantages and gaining traction with new approvals. Core CRM investments will continue to enhance our remote service capabilities, deliver differentiated technologies in our high-voltage platform with the launch of RESONATE HF, the first and only device on the market to bring advanced rate adaptive pacing capability to heart failure patients in the U.S. We will gain approval in Europe for our next-generation pacing lead with INGEVITY+, and we will deliver on our next-generation CRM device platform with our EMPOWER leadless pacemaker, which can serve as either a stand-alone pacemaker, but can also be paired with our EMBLEM S-ICDs. In Diagnostics, we will focus on bringing the power of BSC and Preventice together to drive higher share and increase penetration. We will also continue our investment in LUX-Dx with cadence launches, geographical expansion, along with future inclusion of our HeartLogic technology in LUX-HF. As Mike mentioned in the opening, LUX-HF has been granted breakthrough technology designation by the FDA. And in EP, we will compete in the mapping space with RHYTHMIA and StablePoint, but we will drive differentiation and share gains with our POLARx and Farapulse technologies as we get these technologies into all major markets like the U.S. To discuss further -- in more further detail, these product lines, I'd like to turn things over to Dr. Ken Stein.

That's great. Thanks a lot, Scott. Let's get the slide to advance, please. Our current technologies place us very well positioned to maintain share in our core CRM products while we continue investing for future growth in implantable devices. HeartLogic remains the only proven and FDA approved alert that can give clinicians warning and the opportunity to intervene weeks in advance of a heart failure decompensation. And as Mike and Scott have both mentioned, we have our LUX trend study well underway with the goal of bringing HeartLogic to an implantable cardiac monitor only platform, broadening its use to the large number of patients with heart failure and preserved ejection fraction, also known as diastolic dysfunction. On the ICD side, the EMBLEM S-ICD remains and will remain for many years, the only extrathoracic ICD that can provide protection from sudden death, while also avoiding the significant risks and complications associated with transvenous or retrosternal leads. And we see a future paradigm shift to what we call modular CRM. That's the ability to pair our EMPOWER leadless pacemaker with the S-ICD to provide personalized and coordinated therapy to individual patients. We now have IDE approval of our modular ATP clinical trial for EMPOWER approval, and we'll be starting the process of launching that trial in the coming months. On the diagnostics side, Scott already mentioned the -- I think we are one slide -- there we go, one slide -- on diagnostics side, Scott has already spoken to the unmatched commercial reach, as we combine the Preventice sales force with our RM field team. I also want to acknowledge the R&D and the clinical synergies as we take the industry-leading AI capabilities of the Preventice team and apply those same techniques to the rest of our diagnostic and therapeutic platforms. I also want to point out that we will be the only medtech company that can provide the full portfolio of what docs need to follow the AF patient along their full continuum of care, from ambulatory ECG monitoring through to the LUX-Dx implantable cardiac monitor, to pacemakers and ICDs, to ablation systems using all significant energy sources, RF with force and direct sense, cryoablation and Pulsed Field ablation with our Farapulse acquisition, finally all the way through to stroke prevention with WATCHMAN and WATCHMAN FLX. I can't overstate the strategic importance of something that I just said. We are the only company that can offer all 3 primary treatment modalities for the ablation of atrial arrhythmias, RF, cryo and pulsed field ablation. RHYTHMIA HDx remains the standard setting, high-density, high-definition mapping system and can now be paired in EU and Japan with our IntellaNav STABLEPOINT catheter, that's the only catheter on the market that can combine force sensing, a measure of mechanical coupling of the ablation catheter tissue with DirectSense, our proprietary measure of electrical coupling with tissue. Our U.S. IDE trial, NEwTON AF is well underway, and we anticipate U.S. launch in '23. Our POLARx cryoablation platform has been a resounding success in Europe given its differentiated features versus the competition. It's a true next-generation system designed to have improved workflow, better catheter stability and better visualization of pulmonary vein electrical potentials versus the competition. POLARx is now approved in Japan, where we anticipate beginning commercial launch in October. And also, as Scott mentioned, we've completed enrollment in our FROZEN-AF trial and are in the follow-up phase to get U.S. approval of POLARx. Finally, we're now exiting development of a highly novel cryoballoon technology beyond POLARx that will give physicians more flexibility to address a wider range of patient anatomies. But probably the most exciting addition to our portfolio was the closure of our acquisition of Farapulse, the leaders in Pulsed Field Ablation, a novel, non-thermal and cardiac selective energy source that promises to revolutionize atrial fibrillation therapy. The Farapulse system is the only approved PFA system in Europe, where commercialization began in the first half of this year. And our U.S. IDE trial, ADVENT, is well underway. Let me walk you through the Farapulse procedure and explain why EPs are more excited about this than any other technology I've seen in my nearly 30 years working in the field. What you'll see in the video is the [ Farowave ] catheter, it's the ablation catheter. It can assume either a basket configuration or what we call a flower pedal configuration. And here, you see it introduced into the left atrium, the upper left chamber of the heart through a transseptal puncture. It's advanced into pulmonary veins and energy is delivered. And because this is an electrical field effect, not a thermal effect, you don't need perfect contact to tissue in order to achieve pulmonary vein isolation. And therefore, EPs find this a much more straightforward and much more forgiving procedure. Because the energy is tissue selective, that minimizes the risks of the most feared complications of AF ablation, esophageal injury, pulmonary vein stenosis, chronic phrenic nerve injury or coronary artery injury. And the catheter gives a series of pulses to each of the 4 pulmonary veins eventually resulting in complete electrical isolation of pulmonary vein activity from the left atrium of the heart. In commercial and clinical cases, the Farapulse PFA system has shown to be significantly faster than conventional ablation techniques. As you can see, Farapulse brings 3 advantages to patients and to physicians: the promise of greater safety due to its non-thermal tissue selective nature; the likelihood that greater safety will allow more complete and thorough ablation, bringing with a greater efficacy as well; and finally, greater efficiency as a result of the straightforward and predictable nature of the procedure. But we aren't stopping there and are already in the process of integrating Farapulse with RHYTHMIA as well as evaluating next-generation catheter designs, enabling EPs to use pulse field ablation to treat a wider range of arrhythmias beyond atrial fibrillation. It's important to point out that the various other earlier-stage PFA technologies out there have important differences in wave form and in catheter design and that Farapulse has by far the largest body of long-term published data. And you can see on this slide that those data support the safety, the effectiveness and the efficiency of the Farapulse system. Let's start with safety. Whether for paroxysmal AF or persistent AF, there are no reports of esophageal injury, no reports of pulmonary vein stenosis and no reports of chronic phrenic nerve injury. For efficacy, 85% 12-month freedom from atrial fibrillation for patients with paroxysmal AF, whereas IDE trials of legacy technologies typically report success rates of only around 65%. And I especially want to call out to you the astonishingly good 92% success rate for ablation of persistent AF, where prior technologies have barely been able to offer a 50-50 chance of success at 1 year. Finally, you should note the improved procedural efficiency with 1/3 the left atrial dwell time compared to other technologies, which will lead to greatly enhanced EP Lab throughput. Based on these advantages, we expect the Farapulse platform to grow the overall AF ablation market and to disrupt the entire AF ablation market, not just the market currently served by so-called single-shot ablation technologies. As I said to you earlier, our U.S. IDE trial, ADVENT is well underway. ADVENT is a randomized trial in the paroxysmal AF population, pitting Farapulse head-to-head against RF and cryoablation technologies. And rather than take my word for the revolutionary nature of this technology, let's hear from 2 of the investigators who have first-hand experience with the Farapulse system. [Presentation]

In short, the Farapulse system holds the promise of AF ablation procedures that are safer, that are better and that are faster. With results from ADVENT once it's completed, I can't imagine why this energy source wouldn't become the first-line treatment modality of choice for ablation of atrial fibrillation. Scott?

Thank you, Dr. Stein. And thank you for joining us today to hear from the RM business. We are bullish across our franchises, and we are confident we have the teams and the technology to not only compete, but win in a growing $17 billion market. Thank you. Next, you'll hear from Maulik and the rest of the Neuromodulation leadership team. Maulik?

So good morning, everyone. It's really nice to see everyone in person after a couple of years. Before I get into talking about neuromodulation, we'd like to introduce Jesse Feinkind, Vice President Marketing for pain therapy and Milad Girgis, who is the General Manager for Brain Modulation business, will be presenting each of the segments. So for neuromodulation, I am very excited because I find this space to be constantly innovating. You see a lot of disruption taking place every day. And also at the same time is highly underpenetrated and also high-growth adjacencies. So you [indiscernible] for a very dynamic space. You start to see new technologies, new innovation, new platforms, all those things coming at the same time, almost every month, there's a new story. At the same time, we feel very grateful and excited about being in a leadership position in this space and with our knowledge, history and innovation. Particularly in treatment of pain and pain therapies, we have unparalleled portfolio. Especially with innovation taking place, we just launched our Alpha platform, innovation taking place in SCS with a new waveforms, new ways of therapy and the outcomes that we see in the patients as well as the longevity of the therapy, combined with our RF platform and also the acquisition we made with Vertiflex treating mechanical pain lumbar spinal stenosis. So when you look at it overall, the idea of being that you're providing a toolkit for the interventional pain physicians to be able to provide the right therapy for the patient when they walk in and for the therapy continuum over time. And that gives us tremendous amount of confidence to be able to grow and outpace the market growth and to be the best partner that we can be with a pain physician. On the brain modulation side, our innovation, we look at our almost fourth-generation platform launch with Genus platform in 8 years. We have transformed the space that was rather complacent in the last 20 years. We have seen the innovation really changing how the neurologists and the neurosurgeons look at this therapy space, connecting with our Brainlab partnership platform, ability to look at the planning, how they view programming and looking at the outcomes and improvement outcomes with the directionality that we have provided. That has given them an idea of how they should not only treat the patients, also start looking at adjacencies in the newer markets, how they can provide a treatment options for really a truly transformative unmet needs, particularly in treatment of Alzheimer's and stroke rehabilitation, we'll talk about that a little bit later. We aim to be close to $1 billion in 2021 and the growth accretive for the Boston Scientific [ long-range plan.] So when we look at overall as a market, it's about $3.5 billion, 8% growth as a served market through 2024. In the spinal cord stim, $2.4 billion market, we expect MSD growth but when you look at overall patients, about 3 million patients in chronic neuropathic pain on the FBS [ as ] just a failed back surgery, you see almost 300,000 to 400,000 patients coming in every year. So one of the biggest challenges always remains is highly underpenetrated and the patient awareness remains probably one of the most important factors going forward. In the RF ablation market, we see this as one of the most important intervention for the pain physician, one of the first things they look at as a potential treatment. This is a $300 million market growing at about 10%, but looking at serving almost 10 million patients. So you see this as an opportunity to continue to grow. And Vertiflex, which is a treatment for lumber spine stenosis, 6 million moderate lumbar spine stenosis patients. You're looking at treating of the patients [ on ] mechanical with outcomes data that are there, [ that are ] providing really a toolkit for the physician when we look at overall how do you continue to treat the patient through their pain continuum journey for the life of the patient. On the DBS side, the movement disorder, $700 million market, 10% growth. This is for the Parkinson's disease. At the same time, we see very excited about the new technology entry potentially seeing the market entry expansion into Alzheimer's and for treatment of stroke. And Mike talked about the moonshot, I feel they're a little bit closer than the moon and very excited to see as the clinical results start to develop and evolve, that can be transformative for truly not just for us, but also for the patients, there are no treatments available right now. As a business, when we look at the core for the business, the core growth for the legacy coming from Vertiflex and the growth from Vertiflex and the mechanical pain combined with our spinal cord stim, the innovation that is taking place still evolving as treatment outcomes, the profound pain relief that we see and the longevity of the therapy, as well as from the DBS from the Parkinson's side. On top of that, we see indication expansion taking place for essential tremor for DBS. We expect that to be coming out on label before end of the year. On top of it, ongoing clinical work in Virgin Back to expand the market expansion to provide larger served patient need, as well as for diabetic peripheral neuropathy, we have ongoing clinical work going on. When we look at beyond 2024, very excited about all the clinical work and investments that we have in treatment for depression, Alzheimer's and stroke rehabilitation. With that, I'm going to turn it over to Jesse to talk about our pain therapy leadership and innovation story.

Thanks, Maulik. Good morning, everybody. So when we talk about pain category leadership, you really have to focus and start with the portfolio. And so as we move from left to right, start with spinal cord stimulation business. The success that we had in Q2 was a large part related to the first full launch -- the first full quarter of launch of the WaveWriter Alpha system. So what is WaveWriter Alpha? WaveWriter Alpha is 4 IPGs, 2 primary cells, 2 rechargeable, one 16 contact, one 32 contact. All IPGs have Bluetooth connectivity for a connected patient experience. All IPGs are full-body MRI conditionally safe, and all IPGs have no therapy compromises. So all the IPGs can deliver both our combination therapy, which is our unique ability to simultaneously deliver 2 different waveforms or 2 modalities at the same time and also our new fast paresthesia-free therapy that I'll talk about. Moving on to Vertiflex. The Vertiflex procedure continues to be incredibly in high demand from a training standpoint. We have [ about 4 ] mild-to-moderate lumbar spinal stenosis. We have the largest label around that. And it sits on impressive 5-year RCT data that I'll talk a little more about in the next slide. Moving on to RF ablation. In RF, we are proud to release 2 products. One is the sidekick, which provides larger burns [indiscernible] larger burns for physicians and the Palisade procedure for SI joint pain. But the one thing I want to highlight today is actually what we're considering our fourth product pillar, which is really the Cognita digital ecosystem. And what Cognita does, it actually amplifies the 3 really critical things that every physician -- every pain physician is trying to do. And what are those 3 things. Well, first of all, a pain physician is trying to first increase awareness in their local community about their opioid-free therapies that they have. The next thing they're trying to do is to try to make sure that if a patient that they've identified for certain therapy has quick and [indiscernible] access to that therapy. And third, they try to make sure that patients from a long-term standpoint, longevity standpoint, have good outcomes, good word of mouth in their community. So how does Cognita really help this? Well, first of all, from an identify standpoint, we have tools where we can partner with physicians, so that they understand the correct referral patterns, so their education in their community is fast and efficient. From a managed standpoint, we have tools like the mySCS app, a patient app that I'll talk about, that make sure patients have better trial experience and easier access to trials. And then from a maintained standpoint, we have tools like the patient review that make sure physicians understand how their patients are doing on therapy. So really, when you look at Cognita, it supports for the full patient journey from identification all the way to maintenance of therapy. And then if we look forward, it's actually going to be a fantastic foundation that a lot of innovation that's going to come out in the coming years, particularly some of the innovation in our partnership with IBM, it's going to leverage and build upon. So let's go to the next slide and talk about clinical data because from category leadership, it's important that we continue to invest in data, not just prospective RCTs, but it's also important to go after real-world data and registry data. And so again, starting from left to right, if we look from an SCS standpoint, at the NANS midyear meeting, we released 1 year data on our COMBO RCT, very impressive 84% responder rate. Next year, we will release our 2-year data on the COMBO RCT. From Vertiflex, I mentioned that it sits on an impressive 5-year RCT data. That data at 5 years had 85% opioid reductions in patients. RF continues to have very high success rates. And the one thing that makes us unique with our Cognita digital ecosystem, we're actually going to publish and starting to publish on the benefits that our digital solutions provide to patients. What you see there is mySCS actually had a 40% fewer trial failures in patients using mySCS during the trial, and this is based on a data set of over 1,000 patients. So now what I'd like to do is double click on actually WaveWriter Alpha and FAST. And I talked about the success that a lot of the success that we had in Q2 was really dependent on the physician excitement and the outcomes that we're seeing not in only WaveWriter Alpha but also with FAST therapy, and we really see FAST as a game changer. It's a really differentiator. What you notice is FAST is the paresthesia-free therapy. So FAST has profound pain relief, and also it's the immediacy of that pain relief. With competitive paresthesia-free therapies, patients could go a day or 2 before they actually get any pain relief. With FAST, the immediacy it could happen within minutes. So the patient knows that the therapy is working. They have pain relief while they're in the patients -- while they're in the physician's office, so when the patient leaves the physician office, they leave pain free, they leave with pain relief, which is very different than the competition. What I want to show you is a patient video. And what you're going to see in this video is after about a minute, the patient is going to start seeing relief. The patient is going to make a comment that this feels so weird. What they're commenting on is not that the therapy feels weird because that's a no-feel therapy, the patient doesn't feel anything, what they're going to comment on is the speed at which the therapy takes effect. And you're going to see, as the video goes on, the patient is going to talk about this pain is almost melting away. So let's play that video. [Presentation]

So again, with fast, you have paresthesia-free therapy that not only provides profound pain relief, it's the immediacy of that pain relief. And the reason that we could do that is it operates on a new SCS mechanism of action, right? So that's what makes it very unique. And again, it's pain relief within minutes or while you're -- the patient is in the office versus days. What you're going to see on the right-hand side is that some initial real-world data that we've released. Coming next year, we will release some prospective data. But again, what you see is the profound pain relief. And then you also noticed that the minute, the 11 minutes to onset. So incredibly fast pain relief, profound pain relief. And again, the difference maker is patients receive therapy, they receive relief while they're in the office versus days with the competition. So it provides that patient and that physician therapeutic confidence. So with that, I'd like to turn it over to Milad to talk about the brain franchise.

Thanks, Jesse. Those are results almost like we see with the Parkinson's patients when the therapies turn on and they see benefit right away as fantastic. In DBS, we really, like Maulik has mentioned, we pioneered and ignited a lot of the innovation in the space 9 years ago when we launched in Europe. Back then, we launched our first system, which was a Vercise system, which was the world's first 8-level lead powered by a battery, the smallest wireless rechargeable battery that was designed in the last 25 years. And many then thought we were a little crazy, but as they used it and they saw the benefit for patients, they saw the same results that happened in our VANTAGE study, which was 62% improvement for patients, again, results that had not been seen before. We then continued to further innovate and we pioneered to the world 3 years later, the first chronically implanted patients with directional technology with our Cartesia leads and our Gevia systems. And then today, those systems, our directional capability and directional technology is the world leader with over 30,000 leads that have been implanted in patients around the world. We're very proud of that and proud of our innovation. That innovation continued for -- in our leadership. In the first quarter of this year, we had some portfolio gaps to fill, but we didn't just fill those gaps, we continued to innovate with the launch of Vercise Genus. That was first quarter again of this year, and that was 5 new pulse generators. Those included full body MR capability across primary cell and rechargeable and also secure Bluetooth capability connecting our patient remote control also with the programmers. So thanks again to that. With the foundation also of our INTREPID clinical study, our U.S. study, which now has 4 years of consistent data, physicians are seeing results. And those results have translated into a #1 share position in Europe, a solid total, #2 in the U.S. And in the second quarter, we believe that we were neck and neck for a #1 de novo share in the U.S. for patients. Again, thanks to this technology. Now in DBS, we believe the fundamentals are still about location, location, precise stimulation in the brain with also precise visualization of the target and precise stimulation. You see a picture of that rotating through in the middle. And next year, what we're excited about is the launch of the second phase of Genus, which is our Cartesia X and HX leads. These leads will further directionality. They're going to improve the directional span 2.5x versus Cartesia today and versus the competitive directional leads today. Well, why does that matter? The targets for Parkinson's disease, subthalamic nucleus, which is primarily used today versus GPI, which is another target is double the size. And the targets for these new indications in tremor are also larger. So having a longer span lead will allow physicians to treat and achieve the therapeutic window that's necessary for patients, to treat their effects, to have effects for the therapy and alleviate side effects, like swallowing, like speech. And we believe that this technology also coupled with our partnership with Brainlab, which allows surgeons to see the patient-specific brain anatomy and translate that to neurologists, so they can have point-and-click easy programming solutions as we expand the capability, will again further the therapy and allow more and more surgeons and more and more neurologists to be able to perform this procedure while having the best effects. And speaking about the effects and the capabilities, Maulik mentioned, excitement about having essential tremor approved by the end of this year, and then Alzheimer's and stroke. And real brief, we've mentioned this term moonshot about Alzheimer's. We think that it's -- this partnership and the technology that's used in the design of the study is a moonshot that has the best capability. We're giving it the best chances in this company we're partnering with also has. It's a robust study with 3 arms, that's blinded and sham-controlled. And again, using this technology across 20 centers in the U.S., Germany and Canada that this has the best shots on goal to achieve results for patients that today don't exist. And also looking at treatment for stroke rehabilitation. So thanks again to our technology. We're seeing results like this in front of you. This is a publication and that was just published last week in JAMA Neurology and also presented on stage at the ESSFN conference in Europe. And it's a prospective study looking at a sleep versus a wake DBS, and it was all with our Cartesia system and Vercise system. And initially, you might look at it and say, well, the results look about the same. And that's actually good news. What it shows is that now patients, thanks to this technology, who otherwise would have been resistant to therapy because of being awake during surgery or physicians who might have been hesitant because while patients undergoing general anesthesia might have adverse effect show that actually, again, thanks to the latest innovation in surgery and also technology that the results are comparable. And what this does is a few things. It allows access to more patients because we see that 50% of patients refuse therapy because they're scared of surgery. It also improves the throughput of hospitals and economics at hospitals by a half hour to 2 hours to allow either more DBS or other better economic procedures for hospitals. And again, it furthers and expands the overall market for the procedure. And so again, we believe that we have the right technology and capability to again further the market and to improve patient lives. I'll give that back to you, Mark.

Thanks, Milad. So as you can see, we're very excited about the culture of innovation as part of our DNA. Also, we're very, very patient-centric in terms of looking at patient outcomes. We see this space continue to evolve and us to be a leader in this space in terms of transforming the therapy, as well as the neuromodulation as a general space. We're excited about both the pain therapies, as well as our brain modulation and how we can continue to expand the field, as well as maintain our leadership position. Thank you very much.

We'll now open it up for 15 minutes of Q&A with the Rhythm and Neuro team. Can the Rhythm team come join? I'm going to start with 2 questions from the virtual platform. So first question, I'll give it to Neuromod while our Rhythm team gets settled. This is from both Danielle Antalffy, SVB Leerink and Bob Hopkins at Bank of America. Questions about SCS and the market. And what that looks like in the future? Is that truly COVID impact? How do you think about that in the outer years?

Sure. I think the best example is when we look at our Q2 growth, we saw overall neuromodulation growing at about 14% and about 6% growth for SCS. And that was 95 -- 98% all de novo patients. That gives us the confidence that this remains a very attractive market and that longer term we see continued growth. We do see the impact that took place with COVID with the patients really canceling or the facilities canceling. And it will take some time before the patients come back to the facilities and go through elective procedures. So that was one of the first things that we saw. So overall, we remain confident about the attractiveness of the market. And particularly when we see the -- just even in general, [ 4 ] of FBS, the failed back surgery market, there are 300,000 to 400,000 new patients coming in every year. And when you combine all the players, it's still only treating about 20%. That does not even include the CRPS patients. So overall, the space remains highly attractive. And the biggest challenge remains is really connecting directly to the patients.

Thank you. All right. Next question from -- for Rhythm. This is from Rick Wise at Stifel. So we've got a good installed base with RHYTHMIA, maybe not as big as some of our peers. How does that set us up for success with RHYTHMIA? How do those 2 products interact? And how do you think about that in the future?

Yes. I'll take that. Thanks, Rick, for the question. I think it's really important to emphasize first of all, that you don't need to have RHYTHMIA to be able to use Farapulse and make it a success, right? First of all, many AF ablation procedures don't need any kind of sophisticated mapping navigation system whatsoever. But for those procedures where you do want to have a navigation system, Farapulse has already been used successfully commercially with the other navigation systems out there. Now having said that, we are going to bring integration with RHYTHMIA into a future catheter iteration and clearly intend to make the procedure simpler even more straightforward if we use it with RHYTHMIA, but definitely not going to be an obstacle for those folks who haven't yet jumped on the RHYTHMIA bandwagon.

Thank you. All right. We'll take some in the room.

Larry Biegelsen from Wells Fargo. One for Dr. Stein, one for Scott. So Scott, I'll start with you for Rhythm Management, the $3 billion in 2024 is significantly higher than what we modeled. It's about an 8% CAGR. Could you -- in the market, you said it's about a 5% CAGR over that period. So can you break that down a little bit? What's embedded? Low power, high power, EP and diagnostics, and I have one follow-up for Dr. Stein.

Sure. As we look at the CRM market, I think it's safe to say it's a flattish type market. We expect to be highly competitive in that market. And then our growth will come on the backs of a differentiated diagnostics portfolio and electrophysiology. So that's how we've bridge that gap.

Got it. Dr. Stein, so you're in a unique position where you have a contact for -- the key modalities for ablation in Europe now, contact force sensing, you have cryo and now you have Farapulse. How do you see that playing out over time? You talked about at the end of your presentation, you said you think that Pulsed Field Ablation is going to be the first-line therapy for ablation. We've actually heard that Pulsed Field Ablation could probably take over the cryo market. What's your view kind of 5 years out, how these modalities are used?

Yes. Sure, Larry. First of all, so I'm hopeful about that. We still have to see the clinical trial data clearly. And that's one of the reasons why it's important to have bets on multiple different energy sources. I think the point that I want to make, though, that I think is really important to get over is that Pulsed Field Ablation is not just a competitor with cryo, all right? Our market research shows that it is equally attractive to folks who are still using RF. And the advantages right, safety, speed, efficacy, we equally well for those folks who are still doing RF as it does for folks who are using other single-shot energy sources. And then the last thing I'd say is, as you think about it, the improved throughput, improved safety, improved efficacy and potential for dramatically improved efficacy, for persistent AF, I think, leads to a really reasonable likelihood that just the overall AF ablation market is going to increase as a result of the availability of Pulsed Field Ablation. So sort of to sum it up, I mean we do see it taking share from cryo. But in addition, just as much see it taking share from our RF ablation and also see it significantly increasing the overall AF ablation market.

All right. Next question in the room.

Robbie Marcus, JPMorgan. Two questions for me. One, we've heard that not all Pulsed Field Ablation is same. Maybe spend a minute on your IP here and what makes Farapulse different?

Yes, I'm not going to get into the unique details of the IP, but suffice it to say, there are important differences in catheter design and ability to deliver a uniform electrical field. Again, this is a field effect to the tissue that you're trying to ablate safely and effectively and also really important differences in waveform. And one of the great things about Farapulse, and we were very early investors, right? Again, one of our highly successful VC investments years ago. And they took many, many years to get to waveform that really could consistently show durable effects in terms of pulmonary vein isolation. It's pretty easy to use PFA to get a good looking acute effect. The issue that really has everyone's had a confront though, is whether those acute effects turn into durable lesions. And we've just got so much and it already published long-term chronic data with Farapulse that we have a high degree of confidence that their protected waveform will lead to durable pulmonary vein isolation safely, effectively and quickly.

Great. And maybe a second question on the ambulatory ECG market. There's been some reimbursement issues there. It's a smaller part of the Preventice business today. But how do you think about reimbursement over the long term? And how important is that to this being a successful market?

Yes, I'll take that. Thanks for the question. So first of all, let me remind you that our Preventice business is pretty diversified. Over half of our revenue in Preventice actually sits in MCT and the rest of that revenue is actually split fairly even between cardiac event monitors and long-term ECG. But for the question of long-term ECG, even this year, we continue to grow really fast, both in terms of units and revenue, even with the Novitas pricing decisions that happened both in January and in April. In terms of those pricing decisions, I think it's fair to say we're disappointed in where current Medicare MAC pricing resides today. We hope to get that addressed in the next 12 to 24 months. And really, the issue at hand is traditional pricing inputs into these codes have looked at supplies and equipments on third-party invoices. And that's important because when you just look at a supplier equipment input to pricing, you're missing a lot of the costs that are inherent in long-term ECG delivery, right, the R&D, the AI, the IT infrastructure to compliantly do hundreds of thousands of patient studies per year, the shipping and the freight to get timely diagnostic data in the hands of physicians. So what we're doing about it is we're working with CMS. We're working with the Medicare MAC, we're working with industry and advocacy to kind of address this topic, but it really starts at the root of what inputs do you capture to look at the value of this mortality. Does that help?

I'm going to take another one online and then we'll go back to the room. This is from Joanne Wuensch at Citi. Can you tell us about your clinical trial for the modular ATP device in terms of trial design, number of patients in regulatory and commercial time lines?

Yes. Thanks, Joanne. So as I said, our modular ATP trial is our trial that's designed to get approval of our EMPOWER leadless pacemaker, both as a stand-alone brady pacemaker but also something that can work in concert with our current generation of EMBLEM S-ICDs. And we're now in the process of startup ramp-up to launch that trial later on this year. The trial design is a little bit complicated, follows the FDA guidance for leadless pacing systems. So the overall trial will enroll is intended to enroll 500 patients, but we're able to submit for approval after the first 300 of those patients are enrolled. And again, just based on the complexity of the trial, I can't give you high degree of precision as to when we expect approval. But fair to say that we would hope to see approval near the end of this LRP.

Thanks. Back in the room.

Marie Thibault from BTIG. Just a follow-up here on Farapulse in Europe. I'd love to hear a little bit more about how the clinicians are using it today in terms of how quickly it's taking over RF ablation. And are they still doing post-procedure -- post-procedural cerebral MRI? Has the question of cerebral lesion sort of been put to rest in PFA?

Thanks, Marie. I think first of all, right, we are early in what's frankly a limited launch, just related to ability of Farapulse to scale up production and meet the demand. I can tell you the demand is certainly there. And on the sites where we've launched the product, we honestly expected to hear maybe more bumps in the road when you do an acquisition like this. And so far, haven't seen the bump arise. In terms of MRI and cerebral lesions, there has been some MRI data that's been presented publicly. So far, everything that we have seen indicates that there's no higher risk of cerebral lesions with this technology than with any other technology that involves left-sided access. And presumably, the majority of those lesions are related to air management and just related to getting the transseptal access per se. There is an MRI -- FDA-mandated MRI sub-study as part of ADVENT, but we have a high degree of confidence that we're going to pass that.

The one thing I would add to that is we're very excited to see the collaboration, connectivity of the 2 teams, our BSC team and the Farapulse team in Europe, the training, the targeting, the thoughts on how to roll technologies out together and pretty bullish on the combination there.

Thank you. We'll take another one in the room.

Cecilia Furlong, Morgan Stanley. I wanted to continue with Farapulse. But just ask about -- you talked about persistent, just what your plans are on the clinical front to pursue a persistent indication. And then as you think about long-term applications in terms of market growth, expanding the market versus share capture, but how much of the market expansion component comes from really expanding into persistent?

Yes. Maybe I'll take the first part of the question just in terms of clinical trial plans, and then I'll let Scott and Mark take that financial numbers and the market expansion. So I'm not going to get into a lot of detail about our clinical trial plans. I'd just say suffice it to say, first priority for us is completing enrollment in the ADVENT trial. And in addition to that, we actually have multiple other trials, either already underway or in the planning phase to validate new optimized waveforms, to validate novel catheter designs and also, as you say, for lesion expansion. And really, we expect to see these clinical trials follow in rapid succession, once we get across the goal line with ADVENT.

Yes. And Ken, in terms of the market expansion, I mean, if you start with the EP market, which we all know has been growing low double digits, right, half of that sits in AF ablation roughly and from a procedure perspective at least and half of it is non-AF. If you start with the AF space, I think the first thing to focus on is within that space, roughly 2 out of 3 ablations today globally is still using RF [indiscernible]. So when we think about the market expansion, there will be the cannibalization that happens in a subset of the cryo market, but you've also got this large untapped market, which is over half of the AF ablations that's still using Point RF. So that's the first opportunity for growth. The second opportunity for growth there is, as you mentioned, with persistent indication across all the modalities, but we think Farapulse is uniquely, you saw the clinical data that I can't put up on the screen. And then the other thing is this is really a platform. Ken mentioned next-gen clinical concepts in catheter designs, but we're also looking at how can PFA be expandable outside of traditional de novo PVI.

Thank you. We'll take one more in the room and then conclude Q&A.

Mike Matson from Needham & Company. Another Farapulse question. I guess, based on what you're saying, it sounds like you do expect this to have impact on your growth in Europe before the U.S. trial is completed? In other words, are the clinicians over there going to be waiting for data from ADVENT, like a larger kind of randomized controlled trial for evidence before they really start using it more broadly?

Do you want to take that?

Yes. I think we absolutely expect a combination of technologies that we have in Europe across POLARx and Farapulse uniquely differentiated and a field organization that's aligned to drive the business forward. So it's part of our growth. To be fair, we're really focused on ADVENT. And we're going to make sure we do very well in Europe, the best we can, but we're focused on getting the ADVENT completed and then to your point, use that type of clinical data to drive the business around the world.

And maybe the one thing I'd add there, Scott, right? I mean there's always the curve between early adopters, right? I mean the middle -- the road folks and more conservative folks who want to see more data, really, frankly, we are not hearing a lot of requests or people who want to feel that they need to wait and see more long-term data. The data that's already been presented from Farapulse's chronic and long-term studies really does speak for itself, I think, to most physicians. And the issue with us really in Europe is just scale up to meet the demand at this point. It's not get more data out there to get more people who want to use it.

Okay. I understand. And I got a neuromodulation question, so you guys don't feel left out up there. But I guess, glad to see kind of the indication expansion plans there for DBS, but one thing I didn't hear you talk about was any kind of closed loop plans. I know one of your competitors is really focused on that in the DBS space. So just curious if that's something that you're working on at all?

Yes. So our focus for sure is what we've been talking about, which is precision -- location and precision stimulation, and that's why we've selected our next-generation products. As far as closed loop, it's been interesting research for sure. But in movement disorders, one of the things that's interesting is the biomarker is visible. It's tremor or it's rigidity. And so we're looking at that very methodically, holistically, looking at options also for external closed loop with our [ Clover ] study, which is an external programming capability. And we -- as far as next-generation innovation is pieces that we're not going to talk about quite yet, but we're confident we have the right portfolio in place for the future.

Thank you. All right. Thank you, Team Rhythm and Neuro. All right. COVID protocols prevented Joe from being with us today, but you're in great hands with Ian Meredith and other IC leaders. So let me welcome to stage, Dr. Ian Meredith.

Thanks very much, Lauren, and thank you, everyone. And it is indeed a privilege and a delight to be presenting on behalf of Joe Fitzgerald from the IC Division today, a division with multiple growth drivers in multiple growth markets and a myriad of opportunities to help more patients in the future. I'll be joined by Lance Bates, the President of Coronary Therapies Group; and Nick Spadea-Anello, President of Structural Heart, and the 3 of us will actually take questions at the end of this session. Now we should start with a summary of where we are and where we are going. First, we have a multiyear track record of delivering and exceeding market growth in IC. We're really proud to have diversified into high-growth businesses and therapies, and we're unlocking new and compelling markets along the way. This is underpinned by clear category leadership in the highly profitable Coronary Therapies business. We are building a foundation in structural heart disease. And all of this is reinforced and supported by growing left atrial appendage closure through [ clever ] clinical, smart product leadership, while driving responsible and appropriate therapy awareness. Our goal is to achieve high single-digit growth in IC by high double-digit growth in Structural Heart. Now let's spend a moment reviewing the 4 principal markets we serve today, a $13 billion aggregate market of complex PCI, coronary stents, left atrial appendage closure and structural heart valves. Coronary stands a $3 billion market, that over the last few years has been growth challenged mainly by ASP decline. Lance will outline in more detail in his presentation to follow that we expect some stabilization in this market due to slowing of the ASP decline, offset by slight procedural growth. Complex PCI, a larger market in which we are a clear #1 is growing mid-single digits due to the strength and diversity of our portfolio and the sheer growing burden of atherosclerotic disease. The left atrial appendage closure, we've seen nearly a $1 billion market in 2021, with strong double-digit growth over the coming years, and Nick will discuss in more depth how we're going to grow the therapy, how we're going to sustain U.S. leadership and how we're going to pursue global expansion. And for structural heart disease, with ACURATE neo2 commercial in Europe and the U.S. and Japan approval likely in this LRP we see high single-digit growth for this market with our own growth exceeding that. We expect these markets we serve today, the $13 billion market, to grow to $16 billion by 2024. Core CT growing approximately $1 billion, driven by growth in complex PCI, coronary drug-coated balloons and PCI Guidance. And for TAVR and left atrial appendage closure growing from $6 billion to $8 billion, driven by our global entry into the TAVR market and continued sustained leadership in left atrial appendage closure. Now this growth does not include future market opportunities in mitral valve therapies, circulatory support, interventional heart failure and the like, where we have key VC investments in compelling new therapies. We won't be outlining those in any detail today. You'll just have to trust me that we have a very thoughtful and clever strategy in this space. Now are we in a position to harness the growth we just talked about, that $3 billion? If we look at our current foundation of category leadership, we are indeed very well positioned to meet our business objectives. We hold clear market leadership in coronary therapies where we have strong gross margins and clear plans for expansion, strong operating margins, which are helping to fund the journey. We hold global market leadership in left atrial appendage closure and have unparalleled opportunities to continue to drive left atrial appendage closure leadership through a host of people, product, programs and procedural improvement initiatives that Nick will outline in more detail. We're also heading towards a valve inflection point that I just mentioned with ACURATE neo2 entry into the U.S. and Japan markets. And of course, as I discussed on the previous slide, we have multiple key early-stage VC [indiscernible] on these future market prospects to complement these 3 pillars. So finally, I'd like to so reiterate that our strength in growth has been through diversification. We need only think back 7 to 10 years to recognize that IC was very heavily dependent on the success, or indeed failure, of DES alone. Today, we have a growing and diversified business. So you can see from the IC revenue mix charts here, the pie charts, that in 2019, we were 35% weighted to DES. In 2021, it is 35% structural heart. And as we grow revenue towards 2024, you can see that structural heart and Complex PCI will account for nearly 80% of the revenue. And of course, we'll be early in the launch of our TAVR portfolio in U.S. and Japan at that time. So I'll close by saying that we have tremendous, immense confidence in our people, our programs and our plans, and I will take this opportunity to invite Lance up to outline the coronary therapy strategy. Thank you.

Thank you, Professor Meredith. Hello. I'm Lance Bates, and I am the President of the Coronary Therapies business. And I am excited to share with you how we are going to continue to be accretive to the growth of BSC over the LRP. And as Professor Meredith shared, we have a portfolio that is in a growing market despite the declines in the DES market. Our portfolio, which reaches across drug-eluting stents, balloons, calcium, Complex PCI and PCI guidance. We hold the global market share leadership position, and we do consistently outperform the market. While our legacy stent market has seen significant pricing pressure over the past few years, we do believe that the market is beginning to flatten. We anticipate low single to mid-single-digit decline in the coming years that we feel confident managing, given increasing global PCI procedure volume and our recent innovations in this space. Additionally, we've diversified our portfolio beyond DES with innovation in the complex PCI market, which continues to grow as more patients are being treated with multivessel disease, calcified lesions and comorbidities. The 3 key subsets of the complex PCI market, imaging, calcium and drug-coated balloons, our strong growth markets growing from high-single digits to double digits over the next several years. These market dynamics, plus our current leadership in these spaces will continue to guide our strategy and our investments. And I'm really, really proud that we do have the most comprehensive portfolio across broad treatment spectrum. And we've built our coronary therapies portfolio to align with the clinical mindset of the physician, which is, first, seeing what to treat, then preparing the vessel for treatment and finally, treating the vessel. The unmatched breadth of our portfolio, ranging from atherectomy to cutting balloons to micro and guide catheters and wires, allows us to connect with our physicians at every point of the procedure. And we know that when physicians can see what they're treating before they treat, they see better outcomes for their patients. Our imaging portfolio consists of both IVUS and physiology solutions and is driven through superior best-in-class image quality of our 60 megahertz HD OptiCross system and our COMET II pressure wire, which is a true workhorse wire. These technologies help physicians to better prepare and treat vessels during the PCI procedure. In terms of vessel preparation, we continue to see great success in the calcium market with our rotablator rotational atherectomy system. We have since added to our vessel preparation technologies with the WOLVERINE cutting balloon. And together, both of these have now grown to over $300 million in revenue globally. We also have a new ROTAPRO console delivery system and our new ROTA Drive wire, which can allow for direct wiring in many clinical cases. Lastly, within our treatment portfolio, we continue to innovate with market-leading drug-eluting therapies. Two of the unique innovations include our first-in-the-U.S., 48-millimeter SYNERGY XD as well as our MEGATRON DES, which is purpose-built for larger vessels and highly complex anatomy. These products have value-added features that are unique and allow us to achieve a price premium over current DES. I'm really, really excited to just go a little bit deeper in one of these key opportunities, and that is our investments in the growing intravascular imaging market. Today, approximately 30% of all PCIs have some sort of calcium or disease that needs to be managed prior to treatment. However, imaging is only done today and about 10% to 15% of these cases globally. Based on strong clinical data ranging from the ULTIMA trial to the SYNTAX II trials, we can see that imaging can, in fact, improve outcomes. And if we focus on imaging the PCIs that have calcium at the very least, that would double the size of the imaging market over the next several years to be over $2 billion. Additionally, and this is really important, we find that when we use our IVUS imaging, 90% of the time we pull through the rest of our portfolio, including DES and our calcium treatment options. We are committed to being a leader in this space, and we are investing heavily to build an entirely new platform built on cloud computing and AI capabilities that will deliver even more clinical value to our clinicians. I also want to go a little deeper in another area of innovation that we anticipate we will again be first of its kind in the U.S., and that is our AGENT drug-coated balloon for the treatment of in-stent restenosis, or ISR. ISR occurs over the course of a patient's life in approximately 15% of PCIs, meaning that the stent that was implanted has now restenosed. Current treatment practices for ISR are a bit limited. They include the insertion and layering of another layer of stents or radiation, both of which introduce potential safety risk to the patients. Drug-coated balloons offer additional clinical benefit by providing physicians an option to treat ISRs to open the vessel without adding another layer of metal or stenting, which is likely to lead to another restenosis. We believe that this market could grow to approximately to $700 million and is another area for us to continue to innovate and to lead. Currently, we are enrolling in our AGENT IDE in the U.S., which is ahead of schedule. And earlier this year, we received FDA breakthrough device designation. We anticipate commercial launches in Japan and China sometime in 2023, and in the U.S. in 2024. Beyond the initial approved indication for ISR, there are several other exciting potential clinical applications for AGENT, including smaller vessels, the side branch of a bifurcation in the acute coronary syndrome patient. We are extremely excited about our current and the future state of coronary therapies. We are proud of our innovation and market leadership position in this space, and we will continue to develop new technologies for interventional cardiology that should allow us to continue to grow in the low-single to mid-single digits over the LRP. Thank you. And now I'll turn it over to Nick Spadea-Anello, the President of our Structural Heart business. Thank you.

Well, thank you, Lance. And good morning. I'm excited here -- to be here today to share all the hard work that our team is conducting in structural heart, which we see as one of the largest and fastest-growing opportunities in all of Medtech. Our differentiated structural heart portfolio is positioned to meet unmet patient and customer needs while being focused in areas we feel we can make a meaningful impact in both the short and the long term. These focus areas include left atrial appendage closure with our next generation WATCHMAN FLX device, our transcatheter aortic valve replacement product with our ACURATE neo2 and our embolic protection device with our SENTINEL product. We also have a transcatheter mitral valve angioplasty product in Millipede which is in early feasibility study phase to treat mild or moderate, I should say, to severe mitral regurgitation. Now this market is expected to grow well beyond $7 billion. And we anticipate serving a large population of patients in this segment while driving considerable new growth through continued market development and category leadership in left atrial appendage closure with our WATCHMAN FLX device as well as increasing our presence in this large TAVR marketplace. Looking closer at our efforts in TAVR, we have set our focus on a single valve strategy with the ACURATE neo2 valve. Today, the ACURATE neo2 valve is converting share in Europe and generating new business growth due to excellent clinical performance and the simplicity of deploying the neo2 valve. The key advantage of the ACURATE neo2 valve is its ability to combine unique features of other valves into one valve offering. In our real-world evidence gathering in Europe, we have core lab adjudicated data, that we presented earlier this summer at TVT, that shows that the ACURATE neo2 valve has low paravalvular leak rates, low permanent pacemaker rates, and excellent hemodynamic while also having a unique design to access the coronary arteries in the event that we need to for future interventions. We strongly believe that the ACURATE neo2 valve is a workhorse valve and it's taking share today in Europe, and we anticipate to be able to do the same as we expand in other markets like Japan, China and Latin America as well as the U.S. in 2024. To hear more about ACURATE neo2, let us now turn our attention to experienced neo2 operators, specifically, our co-PI investigators, Dr. Raj Makkar and Dr. Michael Reardon, who are investigators of the ACURATE neo2 IDE. Let us please roll the video. [Presentation]

It's great to hear feedback from 2 well-respected pioneers in the space of TAVR. And let me just reiterate a few things that they had said. First, very easy to use, low paravalvular leak rates, low pacemaker rates, excellent hemodynamic low stroke rates, all while having the ability to access the coronary arteries. And we're really excited because we can offer this all in one, 1 valve. We quickly realized that the opportunity for us to be able to really make this a business advantage for Boston Scientific with the neo2 valve was apparent by being able to globally commercialize and scale the ACURATE neo2 valve in an efficient and really effective way. We plan on introducing the valve in other markets with all large size -- with all sizes, small, medium, large and extra large. And we also anticipate that we're going to try to bring this with all risk classifications. So we see lastly that the financial advantages to scale production of the ACURATE neo2 valve in a more efficient way allows us to have a product that fits our long-term business model. So let me transition into the very, very exciting space of left atrial appendage closure. For the last 6 years, we have been leading the way in this high potential growth market with our legacy WATCHMAN device and now our next-generation WATCHMAN FLX device. As we look at all these AFib patients, there are 35 million patients globally who suffer from atrial fibrillation. And this disease state is expected to grow exponentially with a number of new detection modalities. This patient population is 5x more likely to have a stroke, and 90% of these stroke causing clots, they originate in the left atrial appendage closure or the left atrial appendage. This year, we estimate the global left atrial appendage closure market to be approximately $900 million. And we expect it to grow to approximately $2 billion by the year 2024. Beyond that, we anticipate continued growth, given the multiple research efforts we have initiated with OPTION and CHAMPION-AF. Now while penetration into this market is increasing due to ongoing therapy awareness and clinical evidence, we still believe that penetration is relatively low and that this therapy has a long runway for growth. We have a very strong global leadership position in the left atrial appendage closure market with WATCHMAN FLX and intend on driving further adoption by continuing to advance our technology, create even more robust clinical evidence and driving commercial adoption. Our latest technology, WATCHMAN FLX, is a generation ahead and was designed to advance safety and simplicity of conducting a left atrial appendage closure procedure. The WATCHMAN FLX device has simplified the operator experience considerably by having a closed and fully rounded ball design to drive more procedural safety and ease of use. It also has a new anchoring system that's highly reliable for device stabilization and at the same time, minimizes the chance of pericardial effusion. We observed a 0% embolization rate and a 0% pericardial effusion rate within 7 days of the PINNACLE FLX data. Our new 8-inch strut design nearly doubles the contact points, allowing for a more conforming seal of the left atrial appendage, which resulted again in the PINNACLE FLX data to a 100% effective closure rate. Additionally, we observed 35% shorter procedure times and the ability to treat a much wider range of anatomies. WATCHMAN FLEX is safe and effective while providing the operator what we strongly believe is the best user experience. Not only is WATCHMAN FLX driving operator confidence, but we're seeing referring physician confidence increase as well, given the data from the PINNACLE FLX trial and having a more enhanced, newer and safer design to use. WATCHMAN FLX is now approximately 95% of our global revenue mix. And in the U.S., we no longer sell the legacy WATCHMAN device that we -- and we've converted more than 99%. We only have 3 or 4 more centers in the U.S. that now are contracted to use WATCHMAN FLX. Given the strong interest and the advancement of this product, the conversion happened much faster than we ever anticipated. Now I know there's been an increased interest in the LAAC space given the recent data comparing a competitive device to our older legacy WATCHMAN device. While this study found noninferiority, it's important to note that a higher rate of complications was observed with the competitor's newest device against our older device, which, again, we no longer sell in the U.S. What is important to understand is that the data above from the PINNACLE FLX trial, which looks at our active device, WATCHMAN FLEX. WATCHMAN FLEX saw a higher procedural success rate, 100% effective closure rate, low device-related thrombus and only 0.5% in procedural safety events. These results put WATCHMAN FLX in a class of its own, of what we believe sets a new standard in terms of safety and ease of use for operators. We've seen how WATCHMAN FLX performs in the real world. We've seen how our operators and referrers have embraced WATCHMAN FLX and we're inspired by the opportunity to be able to drive further adoption and challenge our competitors to meet this new standard. We remain fully committed in left atrial appendage closure and our global category leadership via a multipronged approach. First, our dedicated WATCHMAN field team representatives, which have extensive procedural experience we feel offers an advantage to left atrial appendage closure programs and their patients. Our cadence of clinical trials will continue to expand the patient population with OPTION and Champion-AF, with the opportunity to more than double the indicated patient population as we publish these trials. Our TV and digital ecosystem will allow us to continue engaging and driving adoption of the therapy by adding to the 100,000-plus patients that we already have in our patient funnel today. And lastly, our development efforts, the engineers behind the technology advancement, the talented group that we have are focused on innovating the product even further by introducing yet another generation of WATCHMAN FLX in the very near future. We are very, very committed to the space, the only company investing so deeply, and we remain committed by staying generations ahead as we drive further adoption in this area and help more patients with this alternative throughout the world. Thank you, and I'll now turn it over to the PI team and Jeff Mirviss.

Awesome. Thank you, Nick. Well, we're in the home stretch. It's a pleasure to share with you our plans for the peripheral business. I'll be joined by Cat Jennings who is the President of the Peripheral Vascular franchise and Peter Pattison, who is President of the Interventional Oncology franchise. And over the next half hour or so, our aim is to share our plans about how we're going to continue to be an accretive growth driver to Boston Scientific, both on the top and the bottom line and how we're going to extend our category leadership across the 3 franchises within peripheral. And in the next year or so, we'll become a greater than a $2 billion business, with growth outpacing both the market and the Boston Scientific enterprise. And we have a very broad portfolio across the 3 franchises with multiple leading platforms. And we're quite clearly the category leader in peripheral in the spaces where we play. And there's tons of room to innovate in peripheral, and we see significant growth opportunities ahead, especially in categories like drug eluting, our interventional cancer portfolio and Venous especially in the varicose vein market and our Varithena product. And we're also enhancing our positions with investments in clinical trials, unique differentiated ways. We're supporting our technologies with clinical and many product investments that you'll hear about here but a focus on pulmonary embolism and embolization therapies. And so the key takeaway from this presentation is the last bullet, where we expect the peripheral business at Boston Scientific to generate continued accretive growth both on the top and the bottom line. And so this is a view of our served markets. In 2021, we estimate them to be about roughly $8 billion and growing upper-single digits, roughly in that 7% growth range over the next several years. And this is how it's broken out. The interventional oncology market is roughly a $2 billion global market opportunity, growing high-single digits. We're the clear #1 market share leader with our portfolio, roughly double the size of any nearest competitors. And we see this market having excellent growth for the future whether that be through geographic expansion, where there's a lot of opportunity to treat cancer, especially liver cancer in Asia, whether that's extending into new indications and bringing new therapies to help patients with cancer. The largest segment within peripheral is the arterial business. That's about a $4.5 billion market segment, growing roughly mid-single digits. We're the #1 market shareholder and we're the only company that has a state-of-the-art drug-eluting stent and drug-coated balloon, and we see this as a sustainable competitive advantage. And this market is an underserved market. We know that there is a low awareness for peripheral artery disease. There's lots of opportunity to move from bare technologies into drug-eluting technologies. And of course, continued geographic expansion, especially in China, where the adoption of drug-eluting therapies is quite low. So we see continued growth opportunities there. And then finally, we know that the below-the-knee segment, still has a lot of opportunity to help patients to avoid amputations and to provide more durable therapies that are available today. And then finally, the fastest-growing segment within peripheral is the venous category. This is about a $1.5 billion market opportunity globally, growing double digits, seeing nice growth over the last couple of years. We expect that to continue. We're the category leader with a very broad portfolio across the various venous disease states, whether that's in superficial venous like varicose veins, whether that's in deep venous, like deep vein thrombosis or pulmonary embolism. We have a very broad portfolio with some nice reimbursement tailwinds and a real opportunity to deliver more evidence to the field in this category to help patients with their venous disorders. And we see these served markets growing quite nicely over the next several years going from roughly $8 billion today to over $10 billion in roughly that 2024 time frame. The peripheral market has been quite resilient during the pandemic, and we anticipate that continuing over the next several years. We know that there are many patients that have low awareness of the disease in peripheral, many opportunities to increase penetration across the different franchises and the peripheral markets are just fundamentally strong. And we think those market fundamentals will help continue to grow over the next several years and really add a couple of billion dollars of total addressable market over the near term. And this is how Boston Scientific will take advantage of that underlying market growth by delivering double-digit top line growth and expanding and extending our category leadership position across the various franchises. Drug elution is going to be a key driver for us. You'll hear a little bit more about that from Cat and some new data that's coming. But being the only competitor to have both a contemporary drug-eluting stent and drug-coated balloon, we think the prospects for growth and continued growth in this area is very strong. And moving into the below-the-knee segment is a real opportunity for this space, with TheraSphere and Y-90. TheraSphere is the only device that's approved for primary liver cancer. We think that as the market leader, we can continue to grow with the market, expand globally into new geographies, especially in Asia and other emerging markets where Y-90 is either not available or very low adoption. We think that's a big opportunity. And over the next several years, we'll be investing heavily in new indications to take TheraSphere to new solid tumors throughout the body. And you saw on Monday, our data on metastatic colorectal cancer that moves to the liver. We think this is a real opportunity to not only take share but to expand the utilization of TheraSphere from other modalities. And finally, within Venous, the Varithena product has been a really strong growth driver for us in peripheral. It's been accretive growth to the division. It's very strong in terms of the profit contribution. We see emerging market expansion opportunities and then, of course, additional ways we can invest in reimbursement to bolster that therapy. And of course, all of our technologies that we're focused on here today that you'll hear about is underpinned by significant investments in clinical science the type of data to deliver to physicians so that they can practice more and more evidence-based medicine. We feel this has been a differentiator for Boston Scientific, delivering the only head-to-head trials, not 1 but 2 head-to-head trials, to the field of peripheral arterial disease, supporting Level 1 evidence trials in pulmonary embolism that could be guideline-changing to really grow up the market to be a significant market for device therapies for pulmonary embolism, expanding indications beyond just primary liver cancer with TheraSphere and the EPOCH results and then future indications going forward. And then finally, our commitment to diversity, equity and inclusion translates into our clinical strategy as well. We're making a significant investment to deliver evidence in diverse patient populations that, heretofore, has not had the type of evidence that we've seen in other populations. They've been underrepresented in many of the peripheral clinical trials, and we aim to change that with our therapies. So with that, let me turn it over to Peter Pattison, the President of Interventional Oncology.

Great thanks, Jeff. And again, I'm Peter Pattison. I'm in the Interventional Oncology division. Thanks for being here. Thanks for listening. I'm excited to present our story too. I'm actually more excited just to be out of my house. So I'm -- hopefully my enthusiasm shows. Our Oncology division has -- our franchise has changed a little bit probably since the last time we held this meeting. So I just want to walk through our 3 product families very briefly. The first is now we have a pretty compelling cancer therapy franchise. And this really is focused on TheraSphere, which is radioactive microspheres. We have our ICEfx and Galil cryoablation system, which is pretty much standard of care for kidney tumors that are less than 4 centimeters instead of a nephrectomy. It's also used in metastatic lung cancer as well. And we also have, outside the United States, drug-eluting beads. We're treating different kinds of venous malformations and liver cancer as well. Then we have embolization family, and this really looks at ways to block, divert, change blood flow in order to help some of the other procedures go better. And that includes our coils and our bland beads. And lastly, we have our access and delivery. This is a category that helps the therapies and the embolization products get from A to B, and that's largely our wires and our catheters. I want to spend a bit of time here going -- talking about TheraSphere. Now TheraSphere is already our largest product by revenue in the PI division, but it's so far just been a product for HCC. And we want to build this into a franchise or into a platform, into -- because we believe that TheraSphere is the best way to deliver very high doses of radiation to very small places very accurately. And what this allows you to do then is give higher doses of the tumor while preserving healthy tissue. And if you think about it, this is the goal every day of radiation oncology as a discipline in oncology. They're always constantly trying to figure how much dose kind of give to that tumor and how many fractions while sparing healthy tissue. And we think we've got a better mousetrap with TheraSphere. So I'm just going to walk you through kind of our move from product to platform. So the first is our home base. This is HCC. I think you all remember on St. Patrick's Day this year, we got our PMA. We got off of our HDE, our investigational -- kind of quasi approved spot we had with a full PMA based on our legacy data. And since then, we've also put out DOSISPHERE data, which looked at late stage HCC. We had a real-world registry in Target. And of course, again, the legacy data. So -- and that's growing consistent double-digit growth, and that's a home base, and there's still lots of room to grow there. Then we move into secondary liver cancer. This is liver cancer, it comes primarily from colon cancer that is spread to the liver. And the colon is often the only, in first place, that liver that -- sorry, the liver is often the first place that colon cancer will actually spread to. So I'll talk about the EPOCH study that Jeff mentioned on the next slide. Then the next step in this platform evolution is to look at other solid tumors, as Jeff mentioned. So we are very excited about what we've done in the results on glioma or primary brain cancer and as well as prostate cancer. We hope to turn those into first-in-human studies in 2022, and we're pretty confident about those as well. And of course, it's hard to talk about HCC and not mention China. About 55% of the world's HCC comes out of China every year. So that's about 400,000 new patients every year in terms of incidence rate. So we're working through -- it's a complex regulatory environment, which we're working through in China. TheraSphere is actually regulated as a pharmaceutical, which makes things a little more complicated, but we have a good plan to get there. It's the only geography in the world where it is a pharmaceutical. And then, of course, the future -- the futures combo, futures combination, any medical oncologist worth their salt will tell you that. And we believe that combining TheraSphere, a local therapy, with some of these amazing immunotherapies are going to hopefully show that they are at least they can play nicely together and hopefully be even synergistic. And I think that's important to note there's a lot of press about immuno-oncology and immunotherapy, the best immunotherapies only work in a minority of patients. So why is that? So if you can add a local therapy to that like TheraSphere, can you enhance and prime that immune system to get a 1 plus 1 equals 3. That's to be proven, but we're putting our money where our mouth is, and we're going to be doing 2 large studies starting in 2022. So now if my boss' boss is allowed to have a favorite slide, I'm allowed to have a favorite slide as well. So I want to spend some time here talking at the EPOCH trial. And I think it's important because this is -- up till now, there's only been failed studies in this disease setting, albeit in first line, only 100% in failed studies. So we're excited to, again, put our money where our mouth was in the clinical data. And I'm happy to say, and hopefully you all saw this Monday that EPOCH is the first positive Phase III Y-90 trial ever conducted. And I've been in this oncology -- interventional oncology space for 20 years. This is the first positive pivotal study in the field of interventional oncology. So that could be a homework assignment for those in the audience to see if you can prove me wrong on that. But I don't recall any other positive pivotal studies in this field. And so just to kind of give a bit of -- I guess, I'm clearly biased when I get excited about EPOCH. But I think the importance of the EPOCH trial can be borne out in that it was accepted as a late-breaking abstract at the European Society for Medical Oncology, the largest med onc convention in Europe just on Monday. And we also had a simultaneous publication in the American Society of Clinical Oncology, ASCO prime publication, which is a Journal of Clinical Oncology as well. So that's rare, to get those both lined up with something else. So we're -- I think it's hard to disagree with the importance of this study. So just a little background to on what we're trying to accomplish here. The goal here was to see if adding TheraSphere -- we wanted to design a superiority study to see if adding TheraSphere to second-line chemotherapy was going to be superior to second-line chemotherapy alone as second-line treatment for patients with colorectal cancer that it was dominant to the liver disease. So the punchline in all this is that we met the primary endpoint. So we prove that adding TheraSphere to second-line chemotherapy was superior to second-line chemotherapy alone. So the data is right here. We met that primary endpoint of progression-free survival with a hazard ratio of 0.69 in a very statistically meaningful way with a p-value of 0.0013. So what that means in plain English is that patients receiving TheraSphere plus second line, they were 31% likely at any point in the study to show disease progression or death versus chemo alone. So there's going to be like any study, there will be people who are supportive of it and people who are detractors of it. But at the end of the day, it's going to be pretty hard for anybody to say that TheraSphere does not have clinical activity in this patient population. So what does that mean? Well, it means, assuming we are going to be submitting our PMA to add this indication in the United States, and if we're successful, that will unlock about another $0.5 billion in patient in revenue for us. Now the big blue bar there on the right, that is further out. I've been waiting a long time to get into other cancers outside the liver, and this is my passion project over a -- so this clearly -- it's easy to say, clearly, this would be billions of dollars in addressable market if we're successful. But I think I'm going to let our -- one of our KOLs, our industry -- our academic partners at the University of Northwestern in Chicago, Dr. Sam Mouli, who's going to tell us his perspective on treating TheraSphere outside the liver. [Presentation]

Thank you, Dr. Mouli. So in my last slide, I just wanted to kind of go through our -- just mention our vision, interventional oncology, and that's -- our job is to develop new procedures, new indications and new technologies for the interventional radiologists. We've talked a lot about TheraSphere, but just to highlight, our cryoablation platform is a similar concept in terms of going from product to platform. It's the home base, the home base is kidney cancer. So tumors less than 4 centimeters, that is the standard of care, as even said by the AUA for -- again, for RCCs. And we've also just published yesterday, 5-year follow-up on the ECLIPSE trial in the Journal of Thoracic Oncology in terms of lung metastases. And we've also been doing some work in painful bone metastases as well for cancer patients. We're going to continue on the right side to look at making sure we have category leadership in the embolization, access and delivery. We've got some great products coming up, but more on that in the future. So thanks very much. I'll turn it over to Cat Jennings to talk about our vascular portfolio.

My name is Cat Jennings, and I'm the President of Peripheral Vascular business. And I'm so thrilled here in our last section to focus on some of the growth opportunities that we have here in Vascular. Vascular is made up of 2 franchises, arterial, which is the largest market in PI at just under $5 billion, where our focus is really to keep arteries open and patent and minimize the need for reinterventions. Our growth drivers in arterial are our 2 drug eluting products, our drug-eluting stent Eluvia and our drug-coated balloon Ranger. Backed by the first head-to-head clinical trials in this space, these products have been terrific growth drivers for us in this space. Venous is the smallest but the fastest-growing market in PI. And our focus here is on clot management. With our AngioJet and EKOS product lines, they are focused on aspiration as well as dissolving clot and our recently announced agreement to acquire Devoro Medical and bring that technology in to complement the other 2 technologies that we have in this space. We also participate in the treatment of deep obstructive disease with stents and imaging catheters and in Venous, we also treat varicose veins or venous insufficiency with our product, Varithena. We have the distinct advantage of having not 1 but 2 highly differentiated products in the greater than $500 million drug-eluting market. Both Eluvia and Ranger are backed by competitive head-to-head data demonstrating their unique characteristics. With the IMPERIAL trial, we demonstrated that Eluvia is the superior DES on the market today. And with the COMPARE data, we showed that Ranger is as efficacious as the market-leading DCB, but with half the drug dose. This best-in-class data has helped us support premium pricing in the market and has really been an advantage to us as we look to contract with hospitals who are always looking to consolidate vendors. We're on track to exceed $150 million in revenue with our drug-eluting portfolio this year with strong double-digit growth. It's been a global success story. This has been a wonderful example of the way in which we've globalized our business. In Japan, we are currently the #1 DES and the #1 DCB, and we're just beginning our drug-eluting journey in China. Our next-generation product, SAVAL, will be the world's first self-expanding drug-eluting stent for below-the-knee. Our clinical trial enrollment in this space has completed, and we are now awaiting the 12-month end point. This is a very challenging patient population, and we look forward to bringing a technology into the market that can help them. With Eluvia, we have this tremendous opportunity to continue to drive a drug-eluting stent penetration in this market. Today, 4 out of every 5 stents placed in the SFA are bare metal stents. Converting that market to drug-eluting stents would represent a $0.5 billion opportunity, not only creating top line growth but also margin expansion for Boston Scientific. We have proven with the IMPERIAL clinical trial that Eluvia is the superior DES, but we've also made the investments to demonstrate that it potentially could be better than bare metal stents. Two weeks from today, we will present the eminent data set at Veeva, which is the largest randomized clinical trial looking at drug-eluting therapy. Over 750 patients, Eluvia randomized versus all-comer bare metal stents. And this may help give physicians the data that they've been looking for to make some of these transitions, and maybe decide that Eluvia is the best option for their patients who need a stent in the SFA. In Venous, our biggest growth driver in the moment is Varithena, a unique treatment for the large varicose vein market. Varithena has grown double digits for the past 4 quarters in a row on the strength of its ease of use and patient satisfaction. We continue to see great growth opportunities with this therapy within the United States through broader reimbursement coverage outside the United States through geographic expansion and by evaluating additional indications. And we have a robust pipeline in the broader venous portfolio as well as opportunities to enter in new segments. We have products in development for AngioJet, for EKOS as well as diagnostic tools for physicians to aid in identifying and diagnosing PE patients. which is all a terrific lead-in into the agreement we announced yesterday to acquire Devoro Medical. We're very excited to add this highly differentiated technology to our complementary suite of clot management devices. It's a great example of our strategic venture portfolio at play. We've been investors in Devoro since 2019 and have tracked the company's progress for years. As you know, we have the EKOS device, which is a unique clot-dissolving technology. We have AngioJet that has active aspiration, and we will now be complementing these with the Wolf thrombectomy catheter, which has a differentiated mechanism of action. The Wolf platform works by targeting and capturing blood clots using these finger-like prongs that retrieve and remove the clot. You're going to see that in the animation here in just a moment. But you can see how these prongs really capture the clot, pull it into the funnel. And why is that so unique and so interesting to physicians because it helps minimize blood loss during the procedure. You don't need to aspirate the clot in. You can actually mechanically extract it out. It also allows you to not have a need for capital equipment and the fact that this is a forward-facing device means that you can use it in a number of different anatomies. We believe this all can make it a first-choice device for physicians when they're looking to extract clot quickly from any vessel bed. And as we think about applications, we see applications for this in arterial and venous, and we are very excited to begin a limited market release in the second half of next year with this product after close, with the PE trial also planned to begin in the '22. So in conclusion, we're excited about the future of PI at Boston Scientific as we continue to deliver accretive growth on the top line and on the bottom line. And with that, I'll hand it over to Lauren for Q&A.

Thank you, Cat. I'd like to invite everyone back on stage from IC and PI, sorry. All right. We're going to take the first question in the room. You want to get your hands up.

Great. Larry Biegelsen, Wells Fargo. One on WATCHMAN, one on vessel preparation. So I'll start with WATCHMAN. I saw on the slide that the DAPT is under review at FDA. What's your confidence that the data you currently have in hand will lead to kind of a change in the label? And if you're not successful, what's the time line look like? And what do you think the implications are? And I have 1 follow-up.

So maybe we'll have Dr. Meredith start with that since he's working on that.

Thanks, Larry. It's a very good question. So first and foremost, patient choice is critical. So we want to be able to offer patient choice. Now DAPT labeling post left atrial appendage closure with the WATCHMAN legacy device has been available for over 7 years in Europe. We have before the FDA now a comprehensive data set, which is under review, and we hope to have DAPT label before the end of the year in the U.S.

Yes. Okay. Sorry. One maybe a follow-up for you as well. Boston Scientific strategy is always category leadership. You're in the vessel preparation space today. Obviously, IVL is taking off very rapidly. I didn't see that on the slide, but you talked about this exciting VC portfolio that you have. Can you talk about your interest in that area? And could we see something from you within this LRP period?

So naturally, we follow the data closely. And you heard from Lance, we have internal -- a lot of internal capabilities and we follow the data very, very closely. We have a very comprehensive VC portfolio, which, Larry, we don't discuss in-flight VC investments.

All right. We'll take another question in the room.

David Rescott with Truist Securities. I guess on the Vascular segment, the Peripheral Vascular segment, over the past few years, we've kind of seen this shift more towards non lytic-based therapies for treating thromboli specifically in the Venous segment. So I mean as you think about now having a portfolio of non lytic-based therapies as well as lytic-based therapies, how do you kind of balance that push more toward the non lytic segment as well as kind of expanding what will you currently have in the lytic segment? And then I guess just when thinking about kind of more competitors coming into the space, I mean what's the position of Boston Scientific as far as how this allows you to kind of grow expansion within the space and maintaining kind of market share?

Sure, I'm happy to take that. So what I would say is we believe that there's always going to be a need for different types of approaches depending on the goals the physician has with a particular patient. So we see lytics as something that's not going to go away and something that's going to be part of the armamentarium. And frankly, what we're seeing some physicians start to do is actually use some of these technologies together. There's a reason to believe that the clot that you're extracting out with a mechanical solution may not get all of the distal clot that you can actually help dissolve with a technology like EKOS. So we don't necessarily see them as having to be competitive. They may be complementary as we may learn in the future. The other thing that I'd say is it's one of the reasons why we were so interested in Devoro, that very unique mechanism of action, we think will highly differentiate it in the marketplace even if it becomes more crowded over time.

Thank you. All right. We're going to take 1 online, and it's from several analysts. And it's really about WATCHMAN, the data, early feedback on the Amulet launch and how you think a new competitor will help grow the market and how does WATCHMAN fare?

I'll make an opening comment and then hand off to Dr. Meredith here. So first of all, I highlighted in my remarks, we really feel great about the WATCHMAN FLX device, which is our current generation and we're no longer selling the legacy WATCHMAN device in the U.S. market, which is what was compared to. We're really excited that someone else has entered the space. It validates the therapy and -- As I had mentioned, we're underpenetrated in this therapy. So that should help us grow to the level that we projected the market to grow. But when you look at the data across the board, I'll have Dr. Meredith to comment further. But we think we've got a significant advantage with procedural safety as it relates to WATCHMAN FLX.

Thanks, Nick. And to that question about growing the market, I think the -- if we all breathe in and take a step back and just don't look too closely head-to-head comparison and say this is a very large randomized trial in patients who start out with a CHA2DS2-VASc score of around 4.5, estimating around 5% stroke rate a year, and therefore, their endpoint -- 7.5% at the 18-month time point, and you say, what do we actually see? We saw a stroke and systemic embolization amblization in both arms of the trial, absolutely identical at around 2.5%. Fantastic results. So this is a very large study that basically says left atrial appendage closure in patients with atrial fibrillation at high risk of stroke or a moderately high risk of stroke, have a significant reduction in the risk of stroke by left atrial appendage closure. So as a physician, does this actually look like it's going to grow the market? Yes, it's another incremental piece of evidence that left atrial appendage closure works. Now to get down to that point of who gets that market share, then there are many other considerations here. And Nick made the most important point, legacy 2.5 is not the device we have today in 99% of the accounts in the U.S. or 95% of the globe. And FLX was designed to deal with perceived shortcomings with the original device. So when you're looking at those data, they're not directly comparable to what we have today. But the big take-home message here is same level in terms of the safety and efficacy endpoints were achieved in both arms of the trial, but one side of the trial had twice -- almost twice the safety complications and procedural complication. Same endpoint, twice the procedural complications. And the device we've designed and moved on to is even better than what was tested in the trial.

Thank you, Ian. I have one more from online, and then I'll go back to the room. This is from Matt Taylor at UBS. Can you please comment on your TAVR traction in Europe. How many centers are you in? What is your share? And where can that go over time?

Yes. Great question. So we're not going to comment on the specific number of centers that we've launched to. But what we do like and what I can comment on is the accounts where we have launched, we're approaching 20%, and we don't even have a large size valve. So we're being really careful about how we launch and doing it in a right way. And we've had a lot of success. And like you heard some of our key leaders in the field of TAVR mentioned, this is a workhorse valve. And we believe that we can take considerable share over the course of time as we launch into other markets. And this is all accretive to us.

Thanks, Nick. All right. Back to the room.

Marie Thibault from BTIG. I think this question is probably for Cat. Congrats on the Devoro acquisition. Trying to learn a little bit more about it in diligence with clinicians who do VT procedures, it hasn't come up. And I haven't seen any of the human data, at least in the 510(k) summaries and things. So I'd love to hear what kind of the human experience is like and how, in your mind, it differs or perhaps has an advantage over Clot Hunter?

Sure. So you're absolutely right. They've been operating very much in stealth mode. So I wouldn't expect, I think, in fact, their website maybe only went live very shortly ago. So no, you're absolutely right. There hasn't been a lot of information on it. What we have been able to do is observe human cases with some of their arterial products that have been approved. And how I would think about it versus Clot Hunter is Clot Hunter is an accessory that you used together with AngioJet Zelante. And that's a therapy where you can extract a lot of clot for DVT patients. And one of the benefits of that technology is you're actually able to use lytics as together with an aspiration device. When I think about Devoro, what I think about there is this technology that's all about extracting clot mechanically, without the need for lytics. So that's kind of how I think about those 2 products being different. And I think what we're going to find in this broader clot management space is physicians are going to choose different technologies depending on the site of service that they're in, the types of patients that they're seeing, is this a repeat thrombosis? Or is this somebody's first DVT? So I think that this market is going to evolve over time and physicians are going to need this portfolio of tools. And that's one of the reasons why we believe it's such a nice complement to what we already have.

That's really helpful. Maybe just a brief follow-up. Anything you can tell us about the PE trial you're planning for 2022 in terms of maybe a comparator arm or how you're thinking design?

Yes. No, I think at this time, we're just not ready to comment on it.

All right. We'll take another one in the room.

Can you hear -- There we go. Robbie Marcus, JPMorgan. So we've seen a lot of market growth in the Venous segment in Interventional Cardiology, a lot of new product innovation, which is driving market expansion. How do you see yourself keeping up in that space, you're a market leader. You've been growing maybe below some of the smaller but more innovative peers with some of their new products. How do you see yourself continuing and maintaining that leadership over the future?

Venous, are you referring to peripheral venous?

Peripheral venous.

Okay. So I'll hand that to Jeff.

Yes. I mean I think it's sort of what we touched on in the presentation, which is all around category leadership because this is a market that's in early days. It has a lot of room to grow and to increase the penetration for patients. And just like in a lot of categories, there's just not a single tool that's going to be right for all patients, all of the time across PE, DVT and other locations. So we think with a complement of tools, we'll be able to satisfy all the needs of our physicians for their patients and then work with the hospital administration in terms of contracting and partnering with the hospital. So we've been talking about venous for quite a while over many years, and we've seen really good growth. We've grown along with the market and, at times, ahead of the market. And I think now with a full portfolio, we're very excited about capturing at least our fair share, if not even more, of that market growth.

Great. Maybe one more. I'll touch on WATCHMAN again. This is obviously one of the biggest growth drivers, both on a growth rate and a dollar basis. So investors are laser-focused on it. And I know you're not going to give us your revenue split, but it sounds like you feel very confident that you should at least maintain the majority market share for the foreseeable future. Is that a fair statement?

Yes. I want to answer this in the most respectful way because we are very confident in the product, the people that we have and the programs that are wrapped around the entire franchise that we think we can continue to help a lot of patients in a very, very good way with this alternative. There is tremendous growth opportunity. We shared what our approximate estimates are in 2024, and we are focused on getting as much of that share as possible, significant share. I'm confident of that. And we just believe we have made it hard, we will continue to make it hard. And I think the future will tell in terms of whether or not my confidence will generate into the performance we expect. But I feel really good about the position we have with the product, people and the programs.

All right. I'm going to take the last one online, and this is a combo from Chris Pasquale at Guggenheim and Rick Wise at Stifel. Can you give us an update on your mitral and circulatory support programs?

Who wants to confirm?

We can do a joint effort here actually, but perhaps, the mitral program were under AFS study currently. So we have 5 sites actively screening patients in the U.S. We've recruited one patient. We have one patient from outside the U.S. So obviously, we were COVID-affected in 2020 going outside U.S., but the trial we're actively screening patients and marching towards our goal of achieving the objectives. So more to come on that very exciting program.

And for mechanical circulatory support, we have developed internally some very compelling technology that we do believe is differentiated, and we should be at FIM in Q4 this year. And when we're ready, we will share more information in terms of our progress and where we intend to take the product.

Thank you. All right. Thank you very much. That concludes Q&A for IC and PI. And then we're going to welcome to the stage, Dan Brennan, our CFO.

Thanks, Lauren. We're almost there. So hopefully, the morning agenda gave you a great sense and hopefully, you share in the excitement that we have for our pipeline and our portfolio. As we've done in past Investor Days, my goal over the next few slides will be to give you a sense of what we think we can do from a financial perspective. This slide should look familiar. That's intentional. We take the review of this over the 4 measures of our financial brand: consistent, durable revenue growth; differentiated adjusted operating margin expansion; double-digit adjusted earnings per share growth; and strong cash flow. So let's dig a little bit deeper into each one, and Mike previewed some of these, and you've also seen these numbers in the past. They're very consistent to what we've said in the past, again, intentional. Durable revenue growth. 6% to 8% organic CAGR, that's our goal for 2022 to 2024. Longer term, it's faster than the market. We say, our markets are 6%. So that 6% to 8% in 2022 to 2024, we believe, makes sense for the future. It's also what we've done in the past. As Mike said earlier, from 2017 to '19, we were 7.3% organic. So we feel like that 6% to 8% organic revenue range for '22 to '24 makes a lot of sense. On the adjusted operating margin expansion side, we were 26% back in 2019. We've said earlier this year, our goal is to get back to averaging 26% in the second half of this year, and then add 50 basis points plus improvement annually to that over the LRP period of '22 to '24. The long-term goal remains at 30% plus. I have a slide on this. I'll go into a little bit more detail. Double-digit adjusted earnings per share growth. It was 12% for 2017 and 2019. Very proud of that in terms of what we've accomplished as a team. The goal is double-digit for '22 to '24. The goal is double-digit for long-term goals. No change there. Strong cash flow. If you do the first 3 well, on the top of the slide, then strong cash flow is a logical output of that. We had 12% free cash flow growth over '17 to '19. The goal is 10% adjusted free cash flow growth from '22 to '24. That goal remains as a long-term goal. So again, this should look very consistent. It's intentional. We believe these are very strong goals to have, and we're going to have relentless focus to deliver those over the next 3 years. On the right side, in terms of our capital allocation priorities, we've always said over the last few years, our number one priority for capital allocation is high-quality tuck-in adjacent M&A. You've seen that this year. We've done 4 deals so far this year. I think we're proud of those deals, 3 of them from our VC portfolio. We fill in on the back of that with opportunistic share repurchase when available and when possible. So that's our capital allocation priorities. Relative to our balance sheet metrics and our profile there, we think we'll be approaching 2.5x gross debt to EBITDA by the end of this year. And our long-term goal is 2.25 to 2.5, which we think correlates to BBB+ with the rating agencies. We're currently BBB with all 3 agencies and believe at that 2.5 -- 2.25 to 2.5, we'd be BBB+. So I think the team did an awesome job of going through revenue, pipeline, portfolios. I'm not going to spend any more time on that. I'll focus my commentary on the P&L and what we think we can do from expanding an operating margin perspective. Super proud of the team over the last many years, on the left side here, in terms of what we've done in growing adjusted operating margin. It really is -- it's in the fabric of the company. It's part of the culture. It's what we do. It's -- it really is ingrained in the company. So when we looked at 2020 -- 2019, we were 26.1%. I said earlier, our goal is to be 26% average for the second half this year. Add 50 basis points plus to that for the LRP period. And that 30% goal, it's not just there to be on a slide, we actually believe we can get there. There are other companies that operate at that level. There's nothing structurally that prevents us from getting there. We have the plans in place, and we believe we'll have a durably growing, consistently growing top line, which is the lifeblood of adjusted operating margin expansion. So we believe in that 30%-plus goal long term. So let's look at the individual pieces of the P&L and what we'll contribute. And to be clear, we think over the LRP period, all 3 of these can contribute at varying levels over that period, gross margin, SG&A and R&D. Gross margin. Recall, we were 72.1% gross margin in 2019, took a step backwards in '20 and '21, largely from some tailwinds around -- from headwinds around COVID and some inefficiencies and some costs that have come in with COVID. So the goal is to get back to that 72.1% and beyond over time. Headwinds and tailwinds. The key tailwind we have is reducing product cost. We make something for $100 this year, we want to make it for $95 next year. There's a tremendous drumbeat of that, that happens within our organization. Frankly, last year, we lost a little bit of that because the factories weren't operating at full speed. So we lost a bit of that momentum coming into '21 in our ability to reduce product cost. Maniacally focused this year on reaccelerating those value improvement programs and driving that cost out of the system going forward. Headwinds. The inflation is a bit more of a conversation these days. Precious metals, wages, some things that are creeping in. That -- to be clear, that 5% plus reducing of product cost, that's net. So we put that all together, and that's to we put inflation in there. So the goal is still to get that despite the inflation over time. The COVID inefficiencies, we've talked a lot about this over the last 18 months. Some are gone, right? We had some variances that were on the balance sheet as of the end of last year. Those are already cycled through the P&L as of midyear. So as of Q3, those are gone. That's good. There are still some in the P&L. We still are paying more for freight. There's less commercial airliners that are flying. We still pay more for freight relative to moving our products around the world. And there's inefficiencies in things like shift change and other things within -- when you're operating a manufacturing plant and you need to be mindful of COVID, that just adds cost. So as COVID wanes over time, we believe those costs will leave gross margin, and we'll be able to continue to grow gross margin with a goal over time of getting back to that 72.1% and beyond. SG&A is really all about optimizing and driving efficiencies. So in '20 and '21, we've spent less on travel and entertainment, obvious. We've spent more on digital. You saw the team and Mike go through all the great capabilities we've added in digital, which will serve us well for many years. That's great. So the balance of those, the goal is to spend less over that category than we did prior and allow us to be able to add margin expansion points by having less overall SG&A spend. As part of that, we'll be looking to optimize the sales channel. Things are going to be different. The way we're approaching customers, the way we're going to market is going to be different over the next 2, 3, 4 years than it was over the last 3 or 4 years. So that's all part of driving efficiency. And in the background, we have a lot of projects to drive centers of excellence and to drive shared service centers in the admin area, customer service and others. So we believe SG&A can contribute over that time frame as well. The story on R&D is actually pretty simple. We want to do more R&D for less dollars. And how do you do that? We drive efficiencies in clinical. We drive efficiencies by using -- making better use of our global footprint. And low and behold, we can do more R&D for less dollars. We've operated kind of in that 10% to 11% of sales range for the last few years. I don't think we need to be there over the longer term to still be able to fuel that healthy growth on the top line. We can be in that very high single-digit range, just below double digit, but I don't think we need to be at that 10% to 11%. So R&D can contribute. So what the net of that all says is that we believe that 50 basis points year-over-year increase in adjusted gross operating margin expansion over the period will come from all 3 of those areas at different times. We mentioned our number one capital allocation priority is M&A. This is just a bit of a snapshot of what we've done here. If you look at the left side, what's really nice about this is the balance across all the businesses, right? So if you're Jeff Mirviss and you're running PI or if you're Scott Olson and running RM, everybody has participated in this, right? And what's great about it is the VC portfolio. I just mentioned earlier, 3 out of the 4 deals that we did this year came from our VC portfolio. It's just a great seed opportunity for our M&A pipeline, and I'm proud of the process that we run as well as a company. It's extremely disciplined. It's compelling strategic fit, compelling financial returns, and if you don't have both, you just don't get in the room. And so all those deals over there have gotten through a very thorough screening to get to be acquired by Boston Scientific. By the numbers, it's pretty interesting. So we've done $13 billion worth of deals over the last 10 years. So 34 deals. If you look at the number of deals, the vast majority are early stage, makes sense. You're putting bets on the board. You want to place multiple bets across multiple businesses. But when it comes to the dollars deployed, it's actually 80% of the dollars are in the deals that have commercial-stage revenue today, profits today, things like AMS, things like Augmenix, things like bare peripheral vascular. So it's a nice balance of placing the bets -- the early-stage bets across that board, but then also making sure that you have commercial-stage opportunities that we have proven as a team that we drive extremely well. So we have the capacity, and I would look for us to continue to be acquisitive over time, and it remains our number one priority. So in closing, I would just -- this is a slide that Mike showed earlier. So what to expect from us over the next 3 years. I would say, 3 things: continued innovation and category leadership, discipline and focus on achieving our financial goals, all done with an emphasis on doing it in an environmentally and a socially responsible way. Thanks for your attention. I'll turn it back to Lauren for the final Q&A session.

Great. Thank you, Dan. We are inviting Mike and Ian to the stage for final Q&A. I'm going to take the first question online, and then I'll go back to the room. Right, this is a 2 for 1. So this is from Vijay Kumar, Evercore, and Rick Wise at Stifel. Can you talk a little bit more about Q3? Any more context around the potential impact you're seeing in Q3? And any other details you want to share?

Sure. Nice to see everyone again. In terms of Q3, as I mentioned in the opening comments there, we guided to 5% to 7% organic, and we saw quite frankly a really nice July. And then we saw about, call it, 6.5, 7 weeks where it was much softer than we anticipated or I think most people would anticipate given the impact of Delta. And more recently, we've seen improvements in that. So during that process, and again, it's an unlikely to hit. It doesn't mean we have no chance at hitting, it means it's unlikely. And so that was the call that we made. We also said, it's possible for us to continue to hit the full year guidance. And during that time where it was slower, it's basically what all of you saw. We saw fairly unprecedented shutdowns in elective procedures primarily in the southern parts of the U.S. We saw a big impact in the Northwest. We also saw, it's been written in a few other investor conferences, and we -- it sounded like a wimpy comment, but we actually saw more extensive physician and staff vacation period. And we've also seen a little bit of staff challenges at some of the hospitals. So it's really a combination of those 3 things, but primarily, the first one, where elective procedures were significantly more impacted for a period of time there than anticipated. And as I said, it's very possible we hit the full year guidance, and we'll see where we end in the third quarter, but we felt it was appropriate to let the team know. It's not -- we still have a chance at third quarter, but it's likely that we will miss the 5% number.

Thanks, Mike. All right. We'll go to the room.

The 5% is versus '19, organic.

Well done.

Matt Miksic, Credit Suisse. So one quick follow-up on that topic, and then I have a question for Dan. So maybe, Mike, just some additional color, if you could, on which business lines. You have a number of ASC-focused businesses and patient businesses. Maybe some color on that front. And then as I mentioned, one quick one for Dan.

Yes. Unfortunately, we've seen a very consistent trend in terms of which businesses are the most impacted, which are less impacted. Peter Pattison's business and interventional oncology is -- does very well and when you have a peak of the virus like this. Other businesses that are more elected get impacted the most. So the businesses that get impacted the most have traditionally been neuromodulation with SCS and pain -- SCS and DBS and urology. So those 2. And those 2 also businesses are the ones that jump back the fastest when COVID wanes. So I would say, in terms of our BUs, there's an impact across the board and some pressure. Euro and Neuromod are typically impacted the most, and we've seen the majority of the impact in the U.S. There has been an impact in Europe, but less significant, and same thing in Asia Pac with some of the shutdowns and so forth you see in Japan. But a higher proportion of the softness, I would say, was in the U.S. and impacts -- some impact on all businesses, less so on PI and IO and the most in Euro and Neuromod.

So Dan, on -- a question on guidance. So maybe first, thinking about next year, I know you've given 6% to 8% and that's the range. We've had sort of 2 surges this year, which sort of impairs this year as a comp. And I'm just wondering if it's reasonable to think that you should grow potentially above that range next year. And then on just the way you approach guidance. I know you have a lot of products coming in. Some of them will move faster than others, acquisitions that are happening faster than others. I'm just wondering if you could talk a little bit about the way you're looking at guidance now and thinking about it versus, say, what -- has that matter changed since 2018, 2019.

Sure. On the first part of the question, the 6% to 8% next year, we're comfortable with that with where we are today. Obviously, we're not predicting if there's -- what Q4 is and what the waves are in 2022. We look at the numbers, and we think 6% to 8% is a good place for us to be. It's a good place where we've been historically. We think it's a good place to be in the future. So we're not going to be predicting when certain waves will hit. Relative to the guidance philosophy, it's actually very simple and hasn't really changed. It's put a guidance range out that you're highly confident in hitting. So we're likely to miss this guidance range. We've missed a couple of others over the 8 or so years that I've been doing this, and it generally takes something that is highly unpredictable for us to miss a guidance range. Think back to the beginning of '19 when we had the removal of the mesh products, we had the neuromodulation market went south and things that you wouldn't normally predict when you're doing your guidance range. This one, as Mike said, July looked good and then all of a sudden, August and September have been significantly more impacted than I think everybody thought and we thought. So when we get surprised by guidance, it's generally by something that is pretty unpredictable. So we try to put a guidance range out that we're highly confident that we can hit, and we have a pretty good history of doing that.

All right. We'll take another question in the room.

Robert Marcus, JPMorgan. Dan, 2 for you. Maybe I'll just ask them upfront. First, we've seen an unprecedented impact on supply chains around the world. It seems like that's probably going to linger for some time here. How have you thought about that and contemplate that in the guidance range? And then maybe I'll just ask the second one. A lot of people are focused on 2022, and obviously, I don't think you're going to give us guidance here. But is maybe the better way to think about 2022 is use 2019 as the baseline and think about growing off of that rather than the disrupted 2020, 2021 baseline?

So supply chain first. We are blessed to have an incredibly talented and deep team with Ed Mackey and Brad Sorenson and their entire team on the supply chain. So do I worry about it? Yes, it's in pockets around the company in various areas, but they do -- whether it's our suppliers, whether it's our ability to supply our customers, they do an incredible job of managing that, and it has not been an issue to us -- for us that's bubbled up to a reasonable level to date. And the goal is to keep that where it is. On '22, I mean you can look at whatever comp you want. I'm just going to come back to the 6% to 8% that we have out there and think that's a reasonable growth rate over that 3-year LRP. So -- and guidance is normally a February 2 or 3 whenever our Q4 call is.

Yes. My view, we probably -- as you look at '22, we probably talk more back to comparing it versus '21. I think continuing to go back to '19 is like talking about my high school basketball day, it's like at some point, it doesn't matter. And so in '21, it will be -- based on our full year organic guidance we gave and the EPS guidance and margin, it's a fairly stable, good jumping-off point to compare '22 to '21. So I think we'll likely lose how we did in '19 versus '22?

Great. I'm going to take one online. This one is from Rick Wise at Stifel. Strategically, Mike, it seems clear that you're prioritizing smaller disruptive technologies that add to and strengthen your current franchises and bigger long-term opportunities. What's your thinking about larger transactions? Or do you think you'll continue the tuck-in M&A?

Well, it depends on what your view on larger transaction. We thought BTG was a large transaction. I think what was like $4 billion or the exact number. So that to us is a pretty meaty transaction and has transformed the PI business and transformed, I think, the field of interventional oncology. And you saw clinical data here that hasn't been seen in the field. So that's a big deal for us. Lumenis -- so I guess the definition of big. Lumenis was over $1 billion transaction. And so typically, we've been in the more, I don't know, $200 million to $600 million range. I think Preventice was about $1 billion or so, kind of in that flavor. And if we ever see the right opportunity for a larger deal like BTG, we would do it. But you don't see too many of those, and we also want to ensure we hit the debt rating commitments that Dan mentioned and so forth. So our VC portfolio that you saw here and a lot of other companies are talking about it, but it's taken us like 10 years to build it. You just don't do this overnight and say, oh, cool, we want to start investing in VC companies because they're not going to come through for you for 3 or 4 years. And so you've seen a high number of our deals come from that VC portfolio, and we've got a pretty rich menu to choose from, hopefully, and help nurture over the next 3 years.

Thanks. All right. Another one in the room.

Larry Biegelsen, Wells Fargo. Dan -- one for Dan and one for Mike. Dan, on the margin improvement for 2022, just to clarify, on the Q2 call, you talked about the second half 26% is a jumping off point, but it's 50 basis points annually. So for full year '21, you're not at 26%. What -- can you please clarify? You know that there's some confusion around the 50 basis points, what the base is. So please clarify that. And then for Mike, I feel like everybody today said, they could be kind of accretive to the Boston Scientific growth. So -- and so how are you feeling about the 6% to 8%? Could you get -- what would get you to the higher end of that? Put COVID aside, what are some of the key variables here? And are there some business this year that you are...

Yes. So I'll take that one first. Definitely, not all of them are accretive, otherwise a higher guidance that we gave or higher aspirations, I should say -- not aspirations, higher goals. There are a couple of businesses that are going to grow slower. Scott and the team talked about our core CRM business. In a flattish market, we've got a great diagnostics business that will drive higher growth in a really exciting EP business that you heard about will drive growth in Europe and will lag in the U.S. until we get these products approved. But in general, the CRM market is lagging. Our CRM business growth will lag BSC. And then a couple of other areas. Lance has done a tremendous job in coronary. And that DES growth over the next 3 years, it was a significant decline in the last 3 years, but that will significantly improve although still be not accretive to the company. So the DES portion of the business certainly will not be as growing as fast as the company, but it will have a significantly less impact in the next 3 years than it has the past 3, which is really a big win for the company. So those are 2. And then many others we think will be accretive, and that gets us to that 6% to 8%. And there's -- clearly, we're always pushing for upside. You've seen tuck-in deals that will go organic, and we'll continue to do that. And if COVID helps cooperate with us, and we have great launches, we're always going to -- I'd be disappointed, quite frankly, if our performance in the next 3 years isn't a little bit better than what we saw '17 to '19.

On your operating margin question, we clearly look at the second half average that we have as the jumping off point. The goal of that is 26%. We would look to add 50 basis points on top of that. So if we achieve our goal of 26% in the back half of 2021, then a logical place for 2022 would be to add 50 basis points to that.

All right. We'll take another one in the room.

Jayson Bedford. Maybe for Dan or Mike. Relative to your peers, you still spend kind of 150, 200 basis points more on SG&A and even R&D. And I guess the question is, is that necessary or needed to sustain the top line growth? And I guess the question is, just why can't we see more than 50 bps a year in op margin expansion?

Fair question. I think take each one on their own. R&D is obviously the life's blood of growing the top line of the future. I think settling in that 9% to 10% range for us feels like a good place to be. We don't want to -- that still would be higher than peers, and we're okay with that. We don't want to go to the 6% to 7% that some others are at. We have a lot of PMA products, a lot of things that require more investment, as Mike mentioned earlier, high clinical spend. So we feel like that's a good spot. We don't think we need to be in that 10% or 11%, but that's not snap your fingers and make it happen, it's over time. And on the SG&A front, it's really all about the balance in there, right? So when you -- you heard Nick talk about the investments we're making in WATCHMAN, we're happy to make those investments in WATCHMAN. And we try to make the trade-offs in other areas, but again, it's not 150 basis points comes all at once. It's more over time with things like shared service centers and the centers of excellence and things that I mentioned. And then you didn't mention gross margin, but gross margin, again, has gone a bit backwards from we were in '19. So we're confident in that 50 basis points that it's differentiated versus peers. It's the right balance for us coming off the jumping off point of the back half of this year, and it sets us up well to make the trade-offs to continue to grow the top line of the company. Because it's not all about just margin expansion, it's all the financial brand 4 things that I showed, and it's a balance of those 4.

So by the end of the LRP, is the expectation that R&D will be kind of 9%, 10%?

Yes. I think if you look at the size of the company, roughly $12 billion this year in that range and the growth that we gave, you see big numbers happening over the next 3 years. So I think getting to a 9% in R&D, given that scale, is a reasonable number, yes.

Great. Last question is going to come from online. It's Joanne Wuensch at Citi. You have a very robust pipeline. When we meet again in 2 years for this update, which ones do you think will be the greatest driver of revenue? No pressure.

Well, we had 4 hours to go through a lot of. I think the greatest dollar ones -- I mean, there's a bunch of them. I think WATCHMAN clearly is a significant growth driver. You saw the differentiation of WATCHMAN that Dr. Meredith and Nick showed, I think. So that's a big one for us. You've seen that whole -- the PI business has so many doubles in there, many of them. So dollars, I would say, WATCHMAN, the franchises, you see the PI business, urology and Endo have tremendous portfolio, but they're not one home-run product. So I guess with endo, it's that whole disposable category. And the opportunity, I think, that is a game changer, I think, is Farapulse. As that product, you're going to see a little bit less impact in Europe until we get the manufacturing scaled up and more focused on getting the clinical trial. But the enthusiasm from the physician community that we've seen for this is pretty unprecedented that I've seen, and so that would be towards the end of the LRP period, but I think that could be a really -- uniquely good for us.

That's great. That wraps both Q&A and the day. Thank you all for joining.