Boston Scientific Corporation (BSX) Earnings Call Transcript & Summary

Welcome, everyone. Thank you for joining us here today. I'm Lauren Tengler, and I have the pleasure of leading our Investor Relations team here at Boston Scientific. Our program today is going to be about 4 hours, and it's fantastic, and it will bring some of those things you saw in the video to life. But before we get to it, I do have a few housekeeping items. We will be making forward-looking statements, so typical safe harbor and risk factors apply. We will be talking about some products that aren't available in all geographies, and this will tell you a little bit more information about that. A few financial disclaimers to highlight. All of our market estimates are internal, unless we otherwise note. All growth rates are organic unless we otherwise specify. And you'll be hearing a lot about our long-range plan, or LRP, which represents the years 2024 through 2026. And now for today's agenda. We have a wonderful program today, 4.5 hours. We'll complete around 1:00 p.m. We'll hear from many of our leaders across the company, all business units and a spotlight on China. We'll have time throughout the day for Q&A. You'll be able to ask both in the room and online through our webcast platform. We'll also have a short 10-minute break in the middle. We will start with or without you back in the room. And finally, we will post slides at the conclusion of today's event. And I just want to say a quick thank you to everyone who has gotten us here today. There are so many different people and employees at Boston Scientific that have collaborated, and it really highlights the winning spirit of our company, and I'm very, very grateful. With that, I'm going to turn it over to our CEO and Chairman, Mike Mahoney.

Seriously, please keep the applause down. It's deafening. Lauren, great job. Thanks for pulling this together. Good morning, everyone. Thank you for those who came to Boston in person, and we have a bunch of you online. So hopefully, the reception, all that goes well. We're very excited about showcasing Boston Scientific today. And we've had the pleasure of doing a number of Investor Days over the years. And we think this one and the next chapters and chapters ahead for Boston Scientific are truly unique and differentiated. And the theme for this, we didn't spend a ton of money on the marketing for this one, but it's next level. And so what we mean by next level as an organization? If you think of our Investor Days that we've done, which typically had been in 3-year increments. For us, this means next level of innovation that we're bringing across the globe within the company, next level of execution and teamwork and global teamwork, and you'll see that with our very talented team. And the other thing it means to us, from more of a financial perspective, is taking our performance to the next level. And so essentially, what we've done for many years, and you'll see a slide on it, is we typically and commonly delivered stronger organic sales growth versus our peers and double-digit EPS. But from a financial perspective, our aim over this LRP is to be the highest performing medtech large-cap company over this LRP. So we're kind of modifying our goal, which has been better -- be better than peers to be the top company in terms of financial performance, sales growth, EPS, execution, talent retention, and that's what we're striving for over these next 3 years. And you also see how we're investing for the long term for Boston Scientific, to make it a special company beyond these 3 years. So I'm extremely grateful to help lead this team with 40,000 or so employees around the world in 130 countries. It's an honor to do it, and you're going to see a very talented leadership team today. None of this happens without a great culture and a great team. And so there's lots of things you can think about in your day job and things come up around the world. But if you focus the most on culture, talent and innovation, and you put your energy there, typically good things happen. And that's what we do at the company. And so many of our employees are less interested in our P/E ratio and our stock price. They want to be proud of where they work. And we want our employees to be highly engaged. When they're highly engaged, you have an inclusive diverse culture, they perform better. And that's what we continue to see today in 2023 and expect tomorrow. And the common theme for our employees is advancing science for life. How do we help more patients? How do we be the best partner with our physicians? And we have these six core values that I won't have time to go through each one of them, but we talk about these core values all the time within the company. They motivated our employees. And I know as an investment professional, it's very difficult to measure in scorecard, culture, leadership in terms of your numbers and so forth. But I would say our employee retention rates are very, very high. Overall, our employees are very engaged, and we have -- I won't be arrogant and saying easy time, but a relatively easy time to attract talent to Boston Scientific now, and we want to never take that for granted and always have our culture and caring for our employees because they deliver the work every day as the #1 priority. This is a quick overview of where we are in 2023. This is really nothing new since many of you track us, so I'll go quickly here. But it just shows our results in the first two circles for the first half of the year and our full year guidance, which likely everyone in the room already knows. So essentially, for full year 2023, we expect to grow 10% to 11% for the full year. We expect to grow EPS in the mid-teens here of 15% to 17% over 2022. That's the full year guidance we gave at the end of second quarter. And as a reminder, it's important to note that the strength of Boston Scientific is across the globe. All three regions growing quickly, Asia Pac at 20%, Europe at 14% and U.S. at 11%. And every one of our business units, with the exception of Neuromod, which is having a good year, is growing nicely in double digits. So this is really excellent performance across the leaders that you're going to see today, and we look forward to closing out 2023 and moving on to the strat plan. So this is a -- hopefully, nobody will skip the 4 hours, but this is the one-page cheat sheet I think that tries to capture what we're doing as a company. And this speaks to what I mentioned earlier, is we want to move from consistently outperforming our peer group to becoming our goal, the highest-performing large-cap medtech over this 3-year period. And we define that a bit as our organic sales growth CAGR of 8% to 10% over this 3-year period. We do expect the growth rate to be faster we expect in 2025 versus 2024, simply because of the annualization of the significant number of product launches that we have. And you're going to see that today. Many of these great products will be approved and launched in the second half of 2024. So we expect a strong '24, but we do expect acceleration of growth because of that annualization of these major launches in '25, which I think shouldn't be a surprise, and you'll see all the details. We do continue to expect to improve our profitability of 150 basis points of margin expansion over those 3 years, strong double-digit EPS, which we've delivered for a number of years. And Dan Brennan is going to outline how we continue to focus more on our free cash flow conversion, and I'll talk about that specific goal after which at the very end to hear that as the teaser to stay for 4 hours. The key enablers, I mentioned the values of the company, so important in the talent and commitment of our global employees. Category leadership for those who followed the company for a long time is not new, but just, for example, a couple of days ago, we acquired or signed Relievant ,it's another example of us having the broadest, most comprehensive portfolio for key physician call points and having unique innovation within those -- within that portfolio to drive a better contracting and partnership with our customers. And we deploy that strategy across all of our BUs and it's a central part of our tuck-in M&A strategy. Relentless focus on innovation, you're going to hear that like crazy today. And never being satisfied, always being grateful for what we have, but never being satisfied is the key to our winning spirit and enhancing our capabilities, further globalizing the company. You're going to hear from June Chang today, our leader in China, our focus on digital and social responsibilities. This is a -- I think, a fun slide to show because it shows the consistent acceleration of performance of the company over many, many years, even in very difficult times like COVID. So as some of you are old enough to recall, we used to be in markets that grew negative, negative growth markets, and we grew negative. So we were right there growing negative with a negative market, not very well done. But over many, many years, you'll see the slide how we've increased our weighted average market growth rate. We've accelerated our organic growth rate over many LRP periods. And I'm pleased to see in '22, we grew 9%. This year, we guided to 10% to 11%. And despite the COVID impact, which we grew minus 11% in 2020, we grew a little bit over 7% in that 4-year period. So it's a company that actually delivers and exceeds typically the LRP targets that we give you. And you see in '24 through '26, our kind of standard core of 6% to 8%, which is pretty good performance based on the innovative strong durable core we have. But we think in this chapter, we do have the most differentiated launches that I've seen in my career that the team has proven we can sell in Europe and deliver clinically, that takes our launch -- our organic growth CAGR to 8 to 10 over the 3-year period. We do have to walk and chew gum at the same time. We do expect to outgrow our peers, but we also expect to improve margins every year. And this is our margin journey that we've had over many, many years. And I'm proud to say that this year, Dan will go through the goals, we will improve margins again in 2023, just like we did in 2022. And despite all the COVID nightmares that we had as a company, we improved margins over this period, which I'm really proud of our supply chain teams and global teams to do that. Consistently have delivered double-digit EPS growth, and the one area we want to improve on more is our free cash flow generation and that conversion, which we have a goal of 70% in 2026 that Dan will detail out in a bit more. For those who have followed us, we've showed a slide like this, but I don't take this for granted because this is a lot of work by the team. So this shows the markets that we compete in and the weighted average market growth rate of the markets that we compete in or that we enter, and this shows a very nice story where we had a negative 1% weighted average market growth rate dominated by drug eluting stents and CRM. And it's pretty amazing how the team has diversified the portfolio within cardiovascular over these years into what we have today. And you see each quarter, every year, we focus on innovation, and we make strategic portfolio decisions on what to invest in, what to maintain and what not to due to improve this weighted average market growth rate. And so we think in 2026, we'll be competing in the markets that grows 7% to 8%. So if we don't grow faster than 7% to 8%, then we're not doing our jobs and growing faster than the market. And what you'll see in the next 4 hours for each presentation is a detail of their market -- served market. And when you take that composite of all those individual business units, this is essentially the outcome of that. Again, the two most important things for me are innovation, talent and then -- I'm sorry, talent first and innovation second. And this is the ecosystem, which may look common to many other companies. I think what's a bit different is, again, at the center of this is patient care and being a great partner for our physicians, so then they can treat patients more effectively, because we know how difficult it is for hospitals. We want to be their supplier of choice. But this global ecosystem we have of innovation we think works pretty well, and we continue to try and improve it every year. It starts with our internal R&D, where we spend roughly 9-ish percent in R&D. We spend a significant amount of dollars on the R&D footprint. We've expanded that much more globally. Now we have R&D capabilities all over Asia and India and China, in Costa Rica, where we've moved a lot of our sustaining. So I would say even if the percent R&D comes down slightly over the LRP period, our effectiveness of R&D, the globalization of it and leveraging tools like AI make it more effective. As I said, the clinical evidence, you're going to see this across the portfolio. We are leading the way in creating what I call the watchman market and expanding that. You'll see differentiated clinical capabilities in PI. So our clinical evidence, which then drive reimbursement, are so important to us and we make an outsized investment in that area. We've been very active over many, many years. We'll continue to do so with strategic M&A. We have a very active VC portfolio that will continue to make the company stronger beyond this LRP period. You'll see lots of examples of digital and AI that are embedded today in our products, in our IVUS imaging product with AI and our Preventice platform and our neuromodulation business and our Urology suite with StoneSmart. You'll see active AI, not just talking about it, but being used every day in partnerships. As I mentioned, June Chang, our wonderful leader from China, is here. We just signed a partnership with Acotec in China. So we have R&D collaboration, incubator partnerships all over the world. So this is where we spend a lot of energy as a company. And we don't just talk about it once a quarter, we talk about it every day on our portfolio and how we can make it better. For the next 4 hours, me personally, I'm going to personally talk about every one of these circles. So hang in there. You're going to love it. So I'm changing the schedule. The team is not going to talk. So this is the portfolio in one messy page. And what it has is all the divisions on the vertical axis. And on the left-hand side of the page are the most impactful launches, clearly, not all of them because we'll probably launch 80 products or so or 90 in 2023, but these are the more meaningful launches that you'll hear about today on the left hand of the page. On the right-hand of the slide, I think it's important for long-term investors to know we're really excited about '23. We're excited about LRP, but our job is to make Boston Scientific compelling in a fantastic place to be 10 years from now, and we're investing for that long-term growth. But I'm not going to spend any time on this because that's what our team is going to do throughout the day. M&A continues to be a focus area for us. Just to reinforce it, category leadership and moving ourselves into faster growth markets, which you hear often is our goal, but it's actually what we do. And we've acquired, I think, over 40 companies or so over the past 10 years. Most recently, we signed Relievant. This year, we signed Apollo, and we're bringing to market some great acquisitions -- brought to market already Baylis, Farapulse, our cryo platform; Symetis, you'll hear about, which is our ACURATE neo2. So we've had a few that haven't worked out over the years, but the majority of these tuck-in M&As have really improved our innovation cadence and our weighted average market growth rate. And as I mentioned before, our VC portfolio continues to be a big focus area, and we tend to get into companies earlier than some of our peer groups. Some of them work, some of them don't work. But overall, our performance is quite good with that, and that's a very active portfolio. I want to say this because it just reinforces our focus on delivering in '23 being a uniquely special company over this LRP, but [ running ] Boston Scientific could be special for a long time. So these are spaces that aren't just ideas for us and where else we want to invest, these are spaces across the company that we are investing in today to help LRP in '27 through '29 time period. So these are active investments, whether they be organic R&D programs today, some in clinical, some not yet in clinical, or many active VC investments that will continue to grow our weighted average market growth rates, hopefully, beyond what the numbers I just showed you for this LRP period and to continue to accelerate our growth rate. So I'm really proud of our team to be responsible for the future leaders, long-term leaders of Boston Scientific to make this a great company, and we continue to -- there's investments across all these really exciting spaces. So again, this is a quick wrap-up of what you'll see on the financials. And Dan is going to give you a lot more details, taking our performance to the next level. We have high aspirates for the company, but while want to do so, always maintaining a great culture, a caring culture for our employees, doing the right things for society, but really hopefully delivering a unique set of financials along the way. And to do this, for those who play fantasy football, I'm 0-2 in my fantasy football league, but this would be the fantasy draft that you would want if you're creating a medtech team. It's really an honor to work with this leadership team. You're going to meet all of these folks today. Many of these are business unit leaders across our business units. We have extremely talented, recognized Chief Medical Officers in all of our divisions. You'll get to meet many of them today. And this group is the group -- the leader -- many of the leaders who help lead us across the world and really motivate our team of 40,000 employees. So it's an honor to work with this team, and I can't wait for today for you to hear them. So with that, I'm going to turn it over to Art Butcher, and Art's going to summarize -- Art's responsible for our MedSurg businesses as well as our Asia Pac region in China and a few other things in the company as well. So it's an honor for me to turn it over to Art.

Thank you, Mike. Good morning, everyone. I'm Art Butcher, Group President for our MedSurg businesses and Asia Pacific. In that role, I have the honor of supporting the great teams and operations of our MedSurg businesses, Asia Pacific as well as our corporate marketing function. I've been with Boston Scientific for 27 years. And in that time, I've worked extensively in the MedSurg businesses, with over a decade of experience in both the endoscopy business as well as the urology business. I've also had the incredible experience of living and working in Asia for Boston Scientific for over 4 years. So from that experience, it gives me a broad perspective to pull from as I work with these great teams to aim to accelerate these business units. So today, we're going to go into great detail about our MedSurg businesses and Asia Pacific. As a collective group, the MedSurg businesses bring unique value to Boston Scientific with great momentum. We have strong category leadership positions, highly differentiated portfolios, and we play in largely underpenetrated markets. And these markets across MedSurg are valued collectively at over $14 billion and growing as a group over 7%. So very attractive markets that are underpenetrated. And we feel with our portfolio, we have a long runway to keep -- continue winning in those spaces. And Asia Pacific, over the last few years, we have really scaled that business. We now have a 2 -- over $2 billion foundation in Asia Pacific, and it's one of the fastest-growing parts of the company. Those markets continue to be vastly underpenetrated. And with the portfolio you're going to hear about today, we think we're in a great position to continue to deliver above market double-digit growth in Asia Pacific for years to come. So across these businesses and across all of Boston Scientific, part of the culture that Mike mentioned that we really value is our largely decentralized structure. And that gives our business unit leaders that you'll meet today, tremendous autonomy. It leads to faster decision-making, agility, and it actually really drives the winning spirit of our organization. At the same time though, we constantly seek synergistic opportunities that we can drive best practices across the business units to accelerate growth and eliminate redundancy in our SG&A channel. So today, I'm really excited to share with you three examples of how we are using digital and artificial intelligence to do just that, to share best practices and drive them through the entire organization, to delight our customers, to serve more patients, to drive faster growth and reduce costs all at the same time. The first one I want to talk about is our omnichannel strategy, and this is an AI-based sales and marketing platform, where we bring together the touch points that we gather from all of the different platforms where our customers interface with Boston Scientific, including the live interactions with our sales force. We feed that data through an AI interface so that we can deliver the right messaging, the right education at the right time to the right channel to accelerate revenue to bring additional education opportunities to our customers and our customers really appreciate it. And to give you some idea how powerful that can be, we recently ran a pilot in our PCI guidance platform in IC, interventional cardiology. And in the targeted accounts in the omnichannel platform, we drove 9% incremental sales growth versus the base business. That's hugely powerful. So that's what the future is going to look like across Boston Scientific, and we're taking the learnings from that pilot and driving it through the rest of the organization. The second platform I want to talk about is our e-commerce platform. We started this in 2021 in endoscopy, and the idea was to make Boston Scientific as easy as possible for our customers to do business with. So we created an online web portal, think like an Amazon.com-type interface, that was extremely easy to use for our customers to order directly self-service from Boston Scientific. Our customers really appreciated it. It saves time and creates efficiency for them, especially in the fast-growing ASC and OBL space. And in the accounts that adopted our e-commerce portal through self-service, their -- the growth in those endoscopy accounts was 6% higher than in the core Endoscopy business. Again, hugely powerful. We've since rolled that to our Urology business, and we're extending it to other parts of the business in 2024. Not only is it a huge win and delight for our customers, it's also a great cost savings and efficiency for our sales reps who free up their time to be able to focus on higher-level clinical selling activities. So it's another great example. And the third one I just want to share with you today is our expert link suite of tools and technologies to enable remote service and support for our customers. And we're using this all across the company. You'll hear about it in several of the presentations today. But developed during COVID out of necessity, this suite of tools and technologies allows us to remotely support our customers. And today, we're using it for remote patient device calibration, remote capital equipment servicing and importantly, remote physician training and remote proctoring for new procedures and training as we do product launches all the way around the world. So to give you some idea how powerful that can be. We've been using this in product launches, particularly in Asia Pacific, Europe, Latin America, over the last 24 months. And what we have found is that physician proctors who are remote can service as many as 10x as many cases as physician proctors who are present. That's hugely powerful and a big accelerator in terms of product adoption. But remember, remote proctoring is not a full substitute for in-person proctoring. What we have found, though, is that the hybrid of remote and in-person is a great procedure adoption accelerator and simultaneously removes a huge amount of unnecessary travel costs and is higher satisfaction for our customers as well as the proctors who are teaching them. So those are just three great examples of how we're using artificial intelligence and digital to delight our customers, accelerate our business and reduce unnecessary duplication in SG&A. And now at this point in the presentation, I want to transition to our MedSurg business leaders, and we'll start with Jim Cassidy, our President of Neuromodulation. Jim, welcome to the stage.

Great. Well, I'm excited to kick us off with Neuromodulation. It's a dynamic category with significant unmet need. And we've been leaders in the neuromodulation space. We're #1 in pain, #2 in brain stimulation. If you look at pain, it's highly competitive, but it's also a highly underpenetrated market. And we've won in that space through a combination of a patient-centered approach, which is really important when you think about the connectivity between our team and patients in SCS, but also a broad differentiated portfolio. And I think that's what's so compelling about yesterday's announcement of Relievant Medsystems. If you look at that, and it's a whole new category of vertebrogenic pain, significant unmet need and unique to Boston Scientific. And you think about partnering with an interventional pain physician and you look at our portfolio, we've got spinal cord stimulation. We've got traditional RF. We've got Vertiflex. We've got Relievant, and that's a compelling portfolio. I mean that's a portfolio that's tough to match. And I think it sets us apart in this space and puts us as clear leaders in interventional pain. And then on the brain side, we've taken a lot of share in that space. We've built a market-leading technology platform really change the paradigm, frankly, in that space. We've changed the paradigm of how leads are placed, changed the paradigm of how programming is done, and we're going to continue to double down on that technology to further simplify brain simulation so that we can improve access because it's a really powerful therapy for patients. So let me get into our served markets. It's a $3.6 billion served market, growing 6% to 7%. And Obviously, the bulk of that is on the pain side, and particularly within spinal cord stimulation. The big question is, what is the steady state growth for the SCS market? We pegged it at 5% to 6% based off of what we've seen over the past several quarters, but also because of the significant unmet need that's out there and the increased number of indications that are coming to add tailwinds to that SCS market. Adjacent of these interventional pain therapies that have seen significant growth, and they're really more targeted therapies going after specific areas of pain, like Vertiflex for spinal stenosis, or RF ablation for facet joint pain or now relevant technology for vertebrogenic pain. And then lastly, just rounding out the slide is brain modulation, and that's for movement disorders and $800 million market growing at 8%. We've seen a nice tick up in that market coming out of the pandemic as capacity burdens have eased, and that underlying patient demand has come through for brain stimulation. And maybe just to underline that last point on the patient need, you think about the two biggest markets on this slide, our spinal cord stim and deep brain stimulation, we see significant opportunity in both of those markets. And the core spinal cord stimulation market, you think about the traditional indications for SCS, failed back surgery syndrome, complex regional pain, our penetration of incidents is still only at 10% on an incidents basis globally for those traditional indications, not to mention the new indications that have come on board over the past several years that nearly doubled the incidents from the standpoint for SCS. And then on DBS, it's largely a similar story, where you have roughly 11% penetration of incidents. And you think about the reason the other 90%, like what happens to the other 90%? Well, part of it is access to specialists. Another part of it is concerns about the procedure. And you think about our investments here, how do we simplify the procedure? How do we improve efficiencies on the programming? That's getting at the heart of some of the barriers of DBS. So I think the point of this slide is that these are underpenetrated markets, but they don't have to be. And I think that's what we're investing in from a technology standpoint. That's how we're investing from a market development standpoint. Now just to spend a little bit more time on the DBS story. It's a fantastic innovation story, and this is a snapshot of what makes us different. And it starts with a highly flexible stimulation platform. You've got 5 different product choices for patients with movement disorders. And it matters because all these patients, there are so many different movement disorders and the different energy requirements. And so having the ability to choose the right product for the right patient makes a big difference. And then on the other end of the slide here, the physician's ease of use. This is full visualization when you're programming. So you can finally see what you're doing when you're programming a DBS patient. And I'll get into why that matters. But that's totally changed the game in terms of how DBS patients are programmed. And in the middle here is, I think, a real opportunity that remains in this space is like connecting the impact of this therapy to patients. And it's such a powerful therapy for patients, how do we take some of our learnings, some of the other patient-driven therapies within Boston Scientific into the space because the outcomes are so compelling and powerful for patients. But maybe if I can add a little bit of color, I'll add some color on this full visualization concept. And if we could run the video here. While the video is playing, I'm not going to speak directly to the video. I just want to remind everybody like who does the programming in DBS. It's a movement disorder neurologist. And before this technology came to the market, it could take upwards of an hour to program a patient. So think about it. You've got five or six patients coming into the clinic. Literally all you're doing all day is programming patients. And what our technology has really done is two things. And you can kind of see it at the end of this video here. There's two things that are really important. One is you can see the patient's brain anatomy that's that those blue and red shapes -- so that helps you understand where your target is and also where you don't want to be where the side effects are. And then the other piece that's really critical is that green blob in the middle is the control of that green blob that you can see. And that enables you to ensure that your stimulation is not hitting the side effect parts and it's hitting the target. And it's made a huge difference. I mean you talk to any movement disorder neurologists, all of a sudden, you've reduced your programming time by over 50%, doubling your capacity. And that's -- it's one of the big bottlenecks in this therapy. And now you've doubled capacity through this visualization technology. And importantly, it's built on the same stimulation technology that was foundational for this therapy from the INTREPID study. Our INTREPID study, the only double-blind RCT for Parkinson's, that showed really best-in-class increase and on time of over 6 hours at the 1-year mark. So you add that all up, you've got a highly differentiated stimulation or flexible stimulation platform, full visualization when programming and a focus on the patient. And I think that's a really compelling recipe for continued leadership in the deep brain stimulation category. So with that, what I want to do is I want to call up our General Manager for our pain franchise with Boston Scientific, Jesse Feinkind. He has been the architect of our pain leadership strategy and looking forward to hearing from him.

So as Jim mentioned, my name is Jesse Feinkind, I lead the pain franchise. And really what we feel -- when you talk about category leadership and you talk about driving growth in this really competitive marketplace, we really feel it comes down to three strategies. First of all, you have to have an SCS technology that can be personalized to a patient's unique pain patterns. And for us, that personalized system is really Alpha. And Alpha platform is actually four different IPGs. It's two primary cell IPGs. It's two rechargeable IPGs, each with 16 and 32 contacts, all with full body MRI, all with the ability to provide multiple different modalities, multiple different wave forms including our fast algorithm that provides pain relief really within minutes. The Alpha platform, I'll talk about this on the next slide, but the Alpha platform has really achieved and we've published excellent data, industry-leading data in our core indications. And we feel it's a great platform as we look at new indications. After that, we've been talking a lot about, right, what does it mean to be category leadership and you really need to have a broad portfolio. And the addition of Relievant really puts nice feather in our cap around that true category leadership. And what we're trying to do is really be the best partner when it comes to our interventional pain management customers and allow them to treat a broadest -- the broadest set of their interventional pain patients. And speaking of partnership, it's really critical to understand that our customers, they're dealing more -- dealing with the business side of pain management and really dealing with the business side of managing their pain patients. And that's really why we've invested outside of the implant invested in our Cognita Practice Optimization, which is a set of solutions and digital tools that better help our physicians manage their patients' pain. At the end of the day, we want to be more than just a vendor, we want to be a partner with our customers. And that really creates that One Boston strategy, and we believe is our continued innovation in our technology, our continued innovation and indication expansion, our continued innovation in data and our portfolio is really what's going to help drive growth and our continued winning in the space. And I do want to talk about that data. And so what we're looking at here, when you're dealing with pain, right, paying the challenge of pain relief, it's a subjective measure. And what we really need to get to is more objective measures of pain, and that's where functional improvement is so critical. And what we're seeing here is our 3-month endpoint of our combo RCT, actually showed a 26-point functional improvement. And what that means, to put it in perspective, that means there are patients pre-therapy that were severely disabled. In post-therapy, they were brought down to mild to moderate. Again, that means there are patients that couldn't walk, right? Really couldn't have any quality of life, and post-therapy they could. And you could see this is over 50% better than the nearest competitor, and those results have been sustained out for 2 years. And then from an indication expansion standpoint, again, we do believe the Alpha platform is a great platform from indication. And what we're looking at here is the 3-month endpoint of our SOLIS study, which is a nonsurgical back pain study, and 89.5% of patients on our SCS therapy had greater than 50% pain relief. And you can see this is 11x greater than conventional medical management. Our expectation is by the end of '24 to actually have not only nonsurgical back pain indication, but also diabetic peripheral neuropathy indication. And then finally, I do want to talk about the incredible exciting announcement of our acquisition of Relievant Medsystems and the INTERCEPT technology. And so again, we talk about category leadership. And we do feel that this is an incredible high-growth therapy to add to our already diverse interventional pain portfolio. And again, as Mike mentioned, it allows us to be better partners. It allows us to have a lot of synergies. But what is sort of vertebrogenic pain? And so you can see in that image, what it is, is it's when the end plate of the vertebrae become irritated and that can either be do to normal wear and tear over time, that could be due to degenerative disc. And what the INTERCEPT procedure does is it goes into vertebrate and actually ablates the basivertebral nerve. And what's interesting and unique about that nerve is it doesn't regenerate over time. which is why we have a robust durability data out to the 5-year mark. So again, why are we excited and why does it strategically fit? We've talked about category leadership. There's a lot of synergies, especially with our SCS business, right, from a physician standpoint, physician education standpoint, patient education standpoint, all the DTP activities we do, the field marketing, the market development activities there's a large patient base out there, total addressable market of over about $2.5 billion. Over 5 million patients in the United States have vertebrogenic pain. It's supported by a foundation of evidence, including two Level 1 RCTs. We have 5-year data that shows it reduces opiates in patients and reduces the need for injections. And again, they are a high-growth therapy, and we expect them to exceed $70 million this year and we expect over 50% growth next year. So we feel that this is a fantastic platform, fantastic therapy to add to our interventional pain management portfolio and again, adds to our growth and category leadership strategy in pain. So with that, I'll turn it back over to Jim.

Thanks, Jesse. Yes, very excited on Relievant. So I think just to wrap up, these are compelling markets with significant growth opportunities. I mean pain is -- it's going to be an exciting few years in the interventional pain category. We've got two new indications and the combination of Relievant. On the brain stimulation side, we have a significant amount of momentum with our most recent launch of our Neural Navigator software, plus we're continuing to invest in the future for growth. So we've done a lot of work to become leaders in neuromodulation, and we're not stopping. I mean we want to continue to build on our leadership and ultimately help treat more patients with these very powerful neuromodulation therapies. So with that, I want to thank you, and I want to invite up Mike Jones and the Endoscopy team to talk about the Endoscopy vision for the future.

Good morning. Dr. Brian Dunkin and myself are here excited to talk about the Endoscopy division here. So to kick it off for us, the Endoscopy division has been a very consistent growth engine for Boston Scientific. We have a strong track record of consistent high performance that is outpacing our markets that we compete in today. We're also -- our margins are accretive to Boston Scientific. And not only do we have exciting market adjacencies, but even our core business today is clear category leadership with a deep and broad portfolio with multiple platforms. We estimate our served market to be $6 billion, growing at 7%. All three of these segments below are very large patient populations. And within each of these are different disease states and procedures that I'm going to touch on, not all of them because they are very broad. But the pancreatic biliary piece is the largest piece for Boston Scientific endoscopy at a $2 billion market estimate, growing at 8%. Some of the disease and procedures are underneath, but the disease states for us that -- I'm going to talk about is the gallstone disease, that you probably heard of many times. But with pancreatic cancer, just to put a little more context, it's the fourth leading cause of cancer in the U.S. and it falls in this category. In the endoluminal surgery piece for us, it's an emerging market growing segment in the United States and in Europe, about $1 billion estimate today growing at 10%. Some of the diseases underneath are GI bleeding, gastric and colon cancer and obesity. And then finally, our core endoscopy is some of the procedures you'll see before are colonoscopies and upper endoscopies. Both of these are segmented by the aging population that are coming into both these areas. Not only inside these markets do we have large needs from patients, but also we have portfolios that fit each one of these. We can't name them all. Dr. Dunkin will go in more in depth on these first two, but I do want to talk a little bit about the EXALT D. We launched this technology back in 2020. It was our single-use duodenoscope. And this right now is a part of our single use imaging platform that is continuing to grow and being a staple in hospitals, both here in the U.S. and outside as well. You've also heard about AXIOS. When we first acquired this, it was designed for fluid drainage. Brian is going to get more context around different indications. We're expanding that with the AXIOS platform. In the middle bucket, about a year ago, I was standing up here, those bottom two we would not have on the slide deck because they came from the Apollo, the Orbera Balloon in OverStitch, which is a part of our endoluminal surgery category that Dr. Dunkin talk to here in a second. And then finally, on the far side, the core endoscopy. We have a broad range of products. The CRE is a dilating balloon that we use throughout the digestive tract. Infection prevention products are used for pre-procedure, during the procedure and post. And then obviously, we have a very large segment of WallFlex stents that are throughout the anatomy as well. And then here is how do we win as a division? So if you take your eyes to the bottom, we're very well balanced, both from our revenue inside the U.S. and outside. We're about 60-40 split. Then you look up on the top part of the screen here. When you look at our portfolio, we have a very agile and very flexible being able to go between our internal R&D, going between opportunistic with BD and strategic relationships. Also with the driving commercial excellence here, we know it's really important globally to have reimbursement on our technology. So we have a great team that works out of that on a global basis. Professional education, we know it's a key to making sure the physicians are trained to use our products in their procedures and then evidence generation, not only the clinical evidence that we need, but also we need the economic as well. So now I'll turn it over to Brian.

Thanks, Mike, and good morning, everybody. Mike talked about three pillars that really drive our served markets, and I want to dive a bit deeper into two of those. One is pancreaticobiliary and then the other is endoluminal surgery. When we talk about pancreaticobiliary, what we mean is endoscopically treating diseases in the liver and the pancreas, and that includes what we call the ductal systems for those organs. That's the tubes that connects your liver and your pancreas to your intestinal track. And our strategy in the pancreaticobiliary space is to provide a broad portfolio of innovative products that an endoscopist can rely on for treating really any disease in this space. So if I'm an endoscopist, I'm doing a pancreaticobiliary procedure, I reach to the supply shelf for a device that I need, we want that to be a Boston Scientific device. And we've filled this portfolio with really everything you need, the scopes, which are foundational to doing the procedure, the access devices that you need to get into those ductal systems and those organs and then the things that you need to diagnose and treat. And two foundational technologies that are part of that portfolio are single-use scopes and the AXIOS platform that Mike talked about. Boston Scientific Endo has really developed the single-use scope market in the pancreaticobiliary space. That started way back in the late '90s with SpyGlass. SpyGlass is a mini-endoscope that you can literally drive up into the -- that -- those ductal systems of the liver and the pancreas and see disease there. And that revolutionized the pancreaticobiliary space. Prior to SpyGlass, that was an unusual procedure. Today, it is part of standard of practice. And we're on our current fourth generation of SpyGlass with line of sight to fifth and beyond. The other part of the single-use portfolio is EXALT model D that Mike mentioned, the world's first single-use duodenoscope that we brought to market essentially in 2020. That's the foundational endoscope that you need to do pancreaticobiliary procedures. It's the scope that every other device goes through. And one of the beauties of the single-use platform is the ability to rapidly iterate. You're now no longer tied to a capital equipment cycle to upgrade your equipment. And we're on the fourth generation of EXALT model D, even though it's been on the market for 3 years. The last addition to the single-use scope is Discover. Discover is essentially SpyGlass in a form that's optimized to be used by surgeons and interventional radiologists. So now a whole new set of users in the pancreaticobiliary space has the ability to do endoscopy in the liver in the pancreas. And then AXIOS, this group is probably most familiar with AXIOS in the Endoscopy portfolio, really a revolutionary technology. And when you look at AXIOS, it looks a lot like other stents that we manufacture, but you really have to understand what the concept is around this device. AXIOS is designed to connect one organ in the body to another structure. I'm a surgeon. If I do that surgically with suture and needle, that's called an anastomosis. AXIOS is an endoscopically deployed anastomotic device. And so when you think about it with that lens, then you can start to see the potential. It was brought to market to drain fluid collections into the stomach, particularly pancreas fluid collections which sit behind the stomach. But when you extend that anastomotic concept. Now we have indications for gall bladder drainage. Now we can drain bile ducts directly into the intestinal tract, and that's allowing us to transform the pancreaticobiliary space. So a broad portfolio that we serve that leads to our largest franchise and a key growth driver. Now the other pillar is endoluminal surgery. We are living in the next generation of abdominal surgery, and that's endoluminal surgery. We started with open surgery. We then move to laparoscopic surgery in the late '80s and early '90s. And today, we are living in the endoluminal surgery generation. We are solving surgical problems using an endoscopic approach. And at Boston Scientific in endoluminal surgery, we concentrate on those three areas on the left. We want to be able to resect lesions in your intestinal track. We want to manage complications, whether they were created with surgery or endoscopy, and we want to impact obesity through endoluminal bariatrics. Our strategy to do that has been to build the toolbox. As a surgeon, if I walk into the operating room, I've got an entire back table of instruments to choose from in order to allow me to do the best operation I can do. We've been pursuing the same strategy to build a back table of endoluminal surgery technology that an endoscopist can bring to bear to do the procedures that they want to do. And what's really exciting is the Apollo acquisition, which we closed in April of this year because that added endoscopic suturing to our portfolio. Suturing is foundational to surgery. So if you want to impact endoluminal surgery, you got to be able to suture. So now with OverStitch, we have a suturing device that's mounted to the end of the endoscope. And with X-Tack, we have a specialized device that allows us to do pursestring-type closures, very much surgical type activities. And when you take that differentiated technology and then you wrap it in our other Boston Scientific capabilities, like our health economics and market access team that can foster coding coverage and reimbursement, like professional education that Mike talked about, where we can help physicians responsibly adopt these procedures and take them to their patients. And like our evidence generation efforts, that not only demonstrate clinical evidence, but also the value proposition and economic evidence around these devices. And let me finish by talking a little bit about future opportunities. We -- as Mike Mahoney said in his opening, we are grateful and humble for where we are, but we are never satisfied. And so we continue to want to move forward. I talked about endoluminal surgery. We want to continue to push the boundaries of endoluminal surgery. And I'll give you an example, colorectal cancer, third largest -- third most common cancer in the world, second cause of death from cancer. About 2 million new cases of colon cancer will be diagnosed this year worldwide. If you have colon cancer and I want to take it out endoluminally, I can only do very early lesions that don't go deep into the wall of your colon because I'm only able today to remove the inner lining of your colon. I can't create a full hole and then close it. We want to change that paradigm. We want to get to full thickness resection so that we can potentially move colorectal surgery, transabdominal colorectal surgery into an endoluminal paradigm. That middle column endoscopic bariatric and metabolic disease, 42% of Americans today are obese. We need solutions to manage this pandemic and this chronic disease. And we believe that endoluminal interventions are going to be an important part of those solutions. And OverStitch allows us to create what's called an endoscopic sleeve gastroplasty, an ESG. That's an internal placation of your stomach that causes earlier satiety and keeps you full longer and leads to meaningful weight loss. And we're excited to expand on that technology and bring it to more clinicians. And we continue to push the boundaries in this space using the AXIOS platform for some exploratory work that we're doing, with the theory that we can do an internal intestinal bypass endoscopically that can impact metabolic diseases like diabetes. And finally, I will say that Boston Scientific has great expertise across the company in energy, cryo, radiofrequency, pulsed field ablation. In Endo, we want to bring that expertise to the diseases that we impact; lung cancer, pancreas cancer, and we have exploratory work to get us down that road to do it. So an exciting future, part of that future has been built on those two pillars of pancreaticobiliary endoscopy and endoluminal surgery. And with that, I'm going to hand it back to Mike to bring us home.

Thanks, Brian. So just my final thoughts here. So I've been with Boston Scientific for 28 years, all with the Endoscopy division. And I'll echo what Mike said earlier, I'm more excited now than I've ever been about where this division's is going not only from where our portfolio is, but the large capabilities on a big global team that actually help support the Endoscopy division and also very excited where Boston Scientific is going. And hopefully, you've heard that now, and you'll hear it rest of the day. With that, I'd like to bring up the President of Urology, Meghan Scanlon; and the Chief Medical Officer for Urology, Ron Morton.

All righty. Well, hi, everyone. It's good to be back in this forum. Before I jump in, I'd like to take a moment and quickly introduce my colleague, Dr. Ron Morton. Well he's been at Boston Scientific for -- since 2015. He joined us with the AMS acquisition. I don't believe many of you have had the chance to meet him. So Dr. Morton is a urologist, Hopkins trained, specialized in urologic oncology. It's a tough one to get out of your mouth, spent a decent amount of time at Baylor, before becoming the Chief of Urology at [ Ruckers ]. So again, we were very fortunate to have him join the BSC team with the AMS acquisition in 2015. So he'll be joining me in telling the urology story. So what do I want you to know about urology? First and foremost, this is an incredibly cool market. We are the clear category leaders in this market and what excites us and me about this marketplace is the magnitude of unmet needs give us a fertile playground to continue to innovate and drive long-term growth, innovation organically and inorganically abound. Second, we have consistently, as a team at Boston Scientific, outperforms this market. And across the LRP, we intend to do the same thing. Now uniquely with urology, and I think endoscopy is somewhat similar. The sources of growth opportunity are so widely diversified. So there's no one or two products, no one or two countries that we need to nail in order to deliver our financial commitments. We have a broad -- the broadest portfolio in urology by far. And we are still very underweight internationally. So growth opportunities abound across all of our franchises and notably across just about every country in the world. Now Additionally, much like endoscopy, the health of the P&L of urology is very accretive to Boston Scientific. And so as we have scaled meaningfully, right, nearly quadrupling in size since 2014, the pace of that scale has done a lot to help Boston Scientific deliver on its operating margin commitments, and we'll continue to do so. So for the LRP, you can expect urology to grow in the high single digits. Now here's a consistent view on our markets, the served markets. So this is a $4.5 billion market today. We estimate growing about 7% over the LRP. Fundamentally, we serve four clinical franchises. The largest franchise is kidney stone management. We are the clear category leader here, right, a $2.6 billion market, growing in the sort of mid- to low high single digits. Our portfolio here is nicely flanked by two of our most meaningful innovations. LithoVue Elite with intrarenal pressure monitoring, which just launched earlier this year, and the MOSES laser, which came with the Lumenis acquisition that we completed 2 years ago. Those two sort of anchor differentiated technologies really help to amplify and accelerate the broadest and very innovative core stone portfolio, which much like the toolbox that Dr. Dunkin talks of. If you need it in flexible ureteroscopy, Boston Scientific has it, and that's one of the reasons we've been the clear category leader here. Prostate Health is our highest growing market right now, estimated at slightly over $1 billion. And these are the two markets of prostate cancer spacing with radiotherapy and BPH, just to make sure you understand, so the definition of prostate health. That includes our SpaceOAR family of products. We've recent -- a couple of years ago, we launched SpaceOAR Vue, which has done really well in penetrating that market. And then we have one of the broadest portfolios of options to treat BPH, from Rezum, the minimally invasive approach, greenlight and our MOSES laser, which does a really nice job with prostate enucleation. We offer a full continuum for physicians as they aim to treat patients in various stages of the disease. Prosthetic urology is currently a market valued at around $700 million, growing 6% to 8%. And you'll hear from Ron, this is a market that we can absolutely unlock faster growth rate through innovation, and we're really excited about what we're doing there. This is the market that serves erectile dysfunction and incontinence, predominantly for men. And then last, our pelvic floor business, it's a smaller, low single-digit $400 million market, which is currently largely comprised of our stress urinary incontinence portfolio. Now you'll see along the bottom, we've called out three priority adjacencies for us that we have some very smart venture capital bets in; urologic cancers, voiding dysfunction and enabling technologies that ultimately help make a lot of these procedures and approaches go more smoothly and bring efficiency into the marketplace. So category leadership, you heard it from Mike, you'll hear it from each and every one of us today. It's sort of embedded in our DNA. What is going to be needed to sustain the performance that you've seen out of the Urology business? It really comes down to three things, right? It's that continued commitment to category leadership, broadest portfolio compared to any of our competitors, broadest global footprint compared to any of our competitors and a cadence of launches that will continue to allow us to grow faster than market. Second, meaningful innovation. We have a rich legacy of creating markets and launching first-of-their-kind innovations. LithoVue Elite is an exciting one, which Dr. Morton will unpack in a couple of slides. And then lastly, global expansion. This is really one of the more unique growth opportunities, I think, within the BSC divisions because we are still quite underweight in our global mix. 70% of urology revenue has come out of the United States, only 30% from global markets. And so we're investing very thoughtfully on resources, research, evidence and portfolio and capabilities to help accelerate our growth, and we expect to see growth rates out of global markets outpace our successful growth rates in the United States. And so with that, I'm going to turn it over to Dr. Morton to dive deeper into some of our franchises. Thanks, Ron.

Thank you, Meghan. Good morning. Glad to see everyone here today. I too am a suffering fantasy football player like Mike right now, but I believe that, that's because I spend most of my time worrying about clinical evidence for Boston Scientific. So Meghan talked about global expansion, and global expansion is really important to the success of our division. Right now, we are developing evidence plans and developing physical -- physician training programs that help fuel that global expansion across our entire portfolio. But perhaps the best example of that, that I can give to you is how we are working in Asia on Rezum. By developing very directed clinical evidence plans and the long-range training programs that Art talked about earlier, we have been able to unlock Rezum in China and Japan. In China, we took advantage of a very innovative market access program called Green Channel that I think June will talk about later, developed a local clinical evidence plan and executed on a clinical trial in China, long term, long range during COVID by the way, and we're able to unlock that market for Rezum, which is a very large market for us. In Japan, we took real-world evidence data and combine it with our pivotal study data to unlock Rezum in Japan by gaining not only approval, but also optimal reimbursement for that product. So this has been a big driver globally for the growth of that product and that technology. We've also been conducting two large global clinical trials on SpaceOAR and Rezum, our prostate health products. Our SpaceOAR trial called SABRE is an RCT for spacing in the SBRT. SBRT is a form of radiation therapy for prostate cancer that reduces the number of patient radiation visits from approximately 40, down to anywhere from 5 to 8, and is very quickly becoming the optimal -- the preferred way to deliver prostate cancer radiation therapy. And so we are going to have the first RCT data to show the benefit of spacing in that space. And then our vapor trial on Rezum is a global clinical trial that's comparing the efficacy and safety of Rezum to drugs. As you know, the biggest part of the BPH market is drugs. We are going to show -- we've collaborated with our health economics team to devise a trial that's going to show the economic benefits of early intervention in BPH. So these two trials are going to help unlock a lot larger patient population for these two therapies. We've talked about category leadership, and you can't be the category leader without being a leader in innovation. And nowhere is that more important and more evident in our portfolio than in our StoneSmart portfolio. With the acquisition of Lumenis, we are now quite closer to realizing our vision for StoneSmart. As a reminder, StoneSmart is an integrated suite of products linking our LithoVue Elite with pressure sensor to the MOSES laser, and then ultimately to a fluid management system, all driven by AI and AI interface that is going to reduce cognitive burden for physicians and increase procedural efficiency. Now as Meghan noted, we recently launched LithoVue Elite, and we are learning a lot about what we -- what intrarenal pressure really means doing flexible ureteroscopy. We know that physicians are not able to predict how their procedure goes and impacts intrarenal pressure. And we know that there are direct correlations between changes in intrarenal pressure, importantly, increases the resultant complications during flexible ureteroscopy. So with these learnings, we are taking that information and we've developed an innovative clinical trial. It's going to be a registry trial, which gives us the flexibility to add the products from StoneSmart as they evolve and is going to allow us to attack the end points that we know are important to show the benefits of StoneSmart, in particular, reduced complications like sepsis and pain and thermal injury, reduced cognitive burden. We automate laser settings and fluid settings, so the physician doesn't have to worry about that. Now, as Meghan mentioned, I am a urologist, and I've done a ton of stone procedures. And I can tell you that you spend a tremendous amount of time fidgeting with all of these things. By creating this AI interface, we are now going to be able to automate all of those things for the urologists, so that while doing these procedures, there will be tremendous increases in procedural efficiency, and that's going to create a revolution in the way that kidney stone disease is treated. Now I'm really excited to talk to you about prosthetic urology. Our prosthetic urology portfolio, which is mostly ED, is not something that we've talked about with this audience very much, although this is the first time I'm talking to this audience, so I don't know why I'm saying that. But it's really important because it's important to restoring self-esteem and restoring quality of life for men who have ED. Despite the efforts of the companies that make PDE5 inhibitors, you've all seen commercials for Viagra and Cialis, this is a very undertreated disease. The cartoon on the left shows, annually in the United States, there's approximately 20,000 inflatable penile prosthesis performed, and that's just a fraction of the 2 million men that would be candidates for this procedure. So what are we doing? We're innovating with product design and we're innovating with patient awareness campaigns. We recently launched a disposable Furlow tool. Now the Furlow tool is used during every single IPP procedure and has historically been a source of infection. This new disposable furlough tool gives physicians that confidence that they're not going to get an infection during an IPP procedure, which is the most feared complication of that procedure. We're really excited about the launch of a -- coming launch of potentially TENACIO. Our submission is into the FDA for this product. It's a new pump. The pump is going to dramatically improve the patient's ability to inflate and deflate their device and really change their ability to have a work -- a good experience with their device. Importantly, TENACIO, is that orange color isn't because we use bad silicone, it's because our products are coated with InhibiZone, which is our antibiotic coating, we have shown in a number of clinical trials, reduces the risk of infection during IPP procedures. But really, I'm really excited about the future of this portfolio because we are about to leverage capabilities across BSC that allow us to innovate with smart devices that are going to result in a radical transformation the way that patients interact with their devices for ED and incontinence. And it's more -- as important as that is, it's just as important to inform patients about these products and about the experience that they can have and reduce the stigmata associated with talking about IPP devices. And so I want to turn it back over to Meghan so that she can tell you about a campaign that we have that really achieved this.

Thanks, Ron. All right. Unlocking potential in this market, first and foremost, you need to make men aware that this is a solution. This year, we launched it's a 5-part docuseries, I see the smiles. Yes, it's called Hard. Intentionally, it's a double entendre because first and foremost, and I invite you, we put the QR code. Please watch these videos because it takes a topic that can be a little -- I giggled a lot when I first joined this market, but when you watch these videos of these five men who tell their stories of how ED was destroying their lives, was destroying their confidence, was destroying their willingness to even just -- if you were a single go out on a date, not even one date or go on a date and then sabotage it. It tells the story of how hard their journey was to suffer through ED and how hard and long that journey is to actually learn that this is even a thing. So demystifying the penal prosthesis, educating about the peanut prosthesis. We've already seen -- we've reached -- these videos have reached tens of millions of patients, and we've seen a multifold increase to EDCure.org, and already start having patients come asking their physicians about it. So this is what allows us to take that 6% to 8% market that's going to grow over the long-range planning horizon, and we think we can unlock it with the power of some of the transformative technologies into one of those markets that will move up into the top part of Mike's [indiscernible] category. So I'm going to end where I began, which is basically, urology is a wonderful gem of a business within the Boston Scientific franchise. It's a great market. We have a great P&L that contributes a lot to the financial objectives of Boston Scientific, and we expect to continue to earn humbly our category leadership for years to come. Now in addition to being the President of Urology, I am also the Executive Committee Chair for ESG at Boston Scientific. And 1 year ago, we hired our first Vice President of ESG, Kathryn Unger. Now she is currently hiking at the mountains of Peru, the trip of a lifetime. And so can't join you all here today, but she was nice enough to record the following video to help frame how and why Boston Scientific is committed to making a difference in the world and for patients. Please queue the video.

Hello. I'm Kathryn Unger. At Boston Scientific, caring for human life is the common bond that connects our mission, business priorities and ESG strategy. Let me share a few examples. As category leaders, we're serving customers and patients by addressing unmet clinical needs with meaningful innovation to help people live longer, better lives. Our rigorous quality processes and practices underpin our work. Every global manufacturing and distribution site has a shared set of quality metrics and prioritizes preventative measures to continually raise the bar on patient safety and improve product performance. While we're growing our capacity to reach more patients, we're also finding ways to reduce costs, become more efficient and contribute to a healthier planet. To support our goals, we are reducing the environmental impact of our products. Our end-to-end ideal product flow initiative is focused on reliably delivering more products to more patients, while decreasing our materials consumption and minimizing our global energy footprint. Finally, our mission to improve human health is only possible if people around the world have access to quality care. Through our work with Project Hope and our global volunteer programs, we are bringing critical health care to vulnerable communities. We will continue to hold ourselves accountable, including through our ESG scorecard that is part of our annual company-wide bonus plan. We're proud of the progress we've made, and there's much more work to do. Together, we are creating a greater, healthier future for patients, communities and our planet.

Thank you, Meghan and Ron, and I'd like to bring up the rest of the MedSurg team, and we'll start Q&A. We'll have about 15 minutes. Please raise your hand. If you do get a question in the room, please wait for the microphone, state your name, your firm and then your question. I will be taking questions online as well. To access the online questions, just go to the live stream on the left side of the webcast and you'll be able to input a question there. All right. Great.

I will start with Rick Wise. Rick, sorry.

Thank you. Rick Wise from Stifel. Maybe I'll just throw out two specific questions just because we ended on the urology side. The OUS opportunity, as you highlight, does seem really exciting, and you outlined some of the steps you're taking. What kind of growth is embedded in this outlook we've heard, the whole company outlook? What kind of acceleration? What's the growth there? Where are you in this process? And then I'll ask my second question. Every time I talk to Mike, he seems to talk about Farapulse. But I know, and this division clearly is clarifying that there's a lot more excitement here, Mike. On the endoscopy side, I'm fascinated by the AXIOS transluminal stent. It just sounds like more of a platform than I appreciated. Just again, if you could just expand on your comments, how big an opportunity is this? To what extent is it a platform? And we should imagine there's a lot more. I just don't know enough about this space. And to what extent are you converting procedures from robotics or laparoscopy today? Or are you treating new patients that just haven't ever had an opportunity before?

So let me tackle the urology question first. And Lauren, I can't remember, have we shared specific growth rates internationally for urology?

We have.

Okay. All right. No, you'll have to remind me actually what those were. Simple to say, I think we've been consistently in the teens. Yes, mid- to high teens. We continue to grow quite nicely in the United States as well. We expect to see that kind of consistent performance as we -- to me, a healthy business is like 50-50 international to U.S. We've got a long runway to get to that, but we can expect to see, I think, consistent performance like that in the planning horizon.

So I think -- so first of all, I love that you're thinking about AXIOS as a platform technology because that's certainly how we think about it. And as far as like what it's doing and where it's going and the impact, it started with pancreas and simple fluid collections, but then pretty quickly expanded to complex pancreatic disease, where we used to surgically manage this problem, have to clean out infected and dead tissue essentially. That's all done endoscopically now, using AXIOS, literally as a conduit to drive my endoscope into where that tissue is and clean it out. And we've got expanded indications for doing that recently. Moving then to other structures, gall bladder. This is an exciting area. We just got clearance in the U.S. to do AXIOS gallbladder drainage. So connecting your gall bladder to your intestinal tract to manage complex gallbladder disease. This is a problem that patients have been, not surgical candidates, very sick, maybe get a drain placed in by an interventional radiologist and then stuck with that drain, often for the rest of their lives. Now we're transforming that to an internal drainage process, a nonsurgical procedure that they can tolerate. It's been done outside of the U.S. on-label. It's been done inside the U.S. off-label. Now we get it back on-label. We see the future of this also get into the intestinal tract, connecting your stomach to your intestine. It's being done clinically now off-label. We're working to get that on label, and we think we can extend that, as I mentioned, in the metabolic disease. There's good evidence to show that if I can bypass the nutrients that you take in the stomach away from the first part of your intestine, called the duodenum, that I can have a positive impact on your diabetes -- on your type 2 diabetes. And so that's kind of how we're thinking about it. As far as how is it cannibalizing other procedures? I don't -- it may be having some impact on the gall bladder market, but it really is shifting patients that don't have a good solution now and are stuck with a drainage procedure into an internal drainage procedure. I will say -- and sorry to be a little wordy on this, but when you combine Discover and giving interventional radiologists and surgeons the ability to look into the bile duct, and that includes looking into the gallbladder, with technologies like AXIOS, we're changing the whole treatment paradigm among interventional radiologists, surgeons and gastroenterologists on how they're managing complex biliary disease. That's been pretty exciting to get those groups together to talk about.

And just for market sizing, we've said it's historically around $500 million. And what's being described would certainly expanded beyond that. All right. We'll take one over here in the back, Jana. Josh?

Josh Jennings from TD Cowen. I was just hoping to ask about -- I'm not hoping, I'm going to ask about the Apollo Endosurgery acquisition. Maybe just thoughts about that ESG procedure and that market opportunity. I think it's early days of the launch. Any details you can share? And just any efforts to look at combo therapy, weight loss drugs, plus ESG and how that could be impactful?

Yes, I'll jump on the first, but you jump on the second. So on the first, yes, we're -- obviously, we're 6 months into the acquisition. We're really excited about the enthusiasm we see with ESG. As Brian said earlier, unfortunately, 40% of the United States are obese, right? So there's a huge need for this. Some of it is around awareness of what this procedure can do. In the past, it was people mainly on surgical, but those surgical is only 1% of the patient population was getting the surgeries done. And now we're having the ESG trying to get more awareness on the procedure. So we're excited where this is going to go. Brian is probably going to go on the next piece of how this combination could work from a clinical based on what else is out there.

Yes, obviously, it's an area of huge disease burden worldwide. And we're excited to be able to have some impact using a minimally invasive approach. There's a lot to be worked out. First of all, drugs alone, like where do they fit in? You just heard from Mike that only 1% of the eligible population that could get a surgery to manage their obesity. And there's good data on surgery as far as getting rid of your comorbidities, weight loss, all of that kind of thing. But 99% of people who could have that operation are saying, "I don't want an operation." So they need another solution. Drugs maybe is a great solution. A great thing about what drugs are doing is a rising tide is raising all boats. We have more engagement with the medical community now from patients with obesity who used to say, "I don't want surgery and I've tried diet and exercise, and that works." Now they've got a reason to reengage again. And what we need to work out is exactly what you're talking about. Is it meds first, and then ESG, and then maybe surgery? Is it a combo therapy? There are theories on a lot of different ways to do that. We've seen already in clinical practice, people use a stepwise approach, meds first, then I'll go to an endoscopic approach, and then maybe I'll consider a surgical approach. We've seen others that say, "No, no, no, you've got to reset the metabolic set point. You hit them with everything upfront, Meds plus ESG, and then you withdraw meds later." We got to work that out, and that's where I think we can really bring to bear our evidence generation strategy to help sort that all out.

Chris, Nephron.

Chris Pasquale, Nephron. I want to just follow up that point and then one question on the Relievant acquisition. Are you seeing any pause in the pipeline of patients that are coming through for bariatric surgery now that drugs are maybe an option that's more relevant?

Yes. Anecdotally, when we talk to clinicians, particularly surgeons around bypass and sleeve, I've talked to some people from other companies as well, they're calling it a bubble. They think that they're going to see a little shift in time line before we take advantage of that rising tide raises all boats kind of thing, which makes sense. People are going to pursue medicines -- many people are going to pursue medicines as a first step. That's what got them off the couch in the first place. Having said that, there's a lot to work out in medicines. When you do a deep dive in the data, it's a little over 50% of people that are getting the meaningful weight loss that's described. There's a whole list of contraindications to using it. About 10% can't tolerate it. We all know about the costs and what happens when you withdraw the medicine. So it's early days. It's exciting days, but it's early days even for medicines.

And then the Relievant acquisition, a great addition to the portfolio. That's a company that we've been excited about for a while. One of the challenges today or gating factor to that business has been the reimbursement status and getting patients through the approval process. How are you thinking about that and the time line to get broad commercial coverage for INTERCEPT?

Yes. Thanks, Chris. No, I think what's been impressive about that therapy, I think one of the things that really attracted us to the therapy are the long-term outcomes. So you've got really durable, both on the pain and functional. And the big piece, I think, to get to your question, is the health care utilization for these patients as well, where you see significant reductions in opioids, significant reductions in injections. And if you on a paired cohort basis, lower fusions in this population as well. So that's the foundation of what gives us a lot of confidence from a commercial payer and a broader payer standpoint. They currently have roughly 30% of covered lives. They've had some momentum over the past several quarters in terms of the local coverage decision, the broad national coverage decision from Cigna. I think the other piece that's really important is that we're not talking about all of chronic low back pain. We're talking about a very well-defined group of patients. And so I think that gives additional comfort, in addition to the data -- the positive data out to 5 years. And I think then the last piece is societal support. So you've got the backing of the NASS, the spine surgery community behind this procedure, which is really important as commercial payers look at this like a durable therapy, lower health care utilization and then support from the societies is a really powerful combination. And so they're on their way. They're making progress, and we're going to continue to push down that path.

Thanks, Jim. Mike?

Mike Polark, Wolfe Research. I have a question on SCS around the corner is ECAP-based sensing, the so-called closed loop from a private company and one of your larger competitors. I'm curious, what is Boston's take on this technology? And kind of what is your plan? Do you have interest in pursuing still to stimulation? And/or kind of what's your message in counterdetailing the closed loop as it comes out in the coming years?

Yes. Thanks for the question. When it comes to SDS technology, I think you -- the way we look at it is like what fundamentally do we need, and we really need longevity of therapy. And we believe the way you get longevity of therapy is the way to personalize therapy for a patient. And so what we find is, over time, a patient is going to need different waveforms. And what we have with our Alpha technology is we have the ability to provide different waveforms over time as a patient sort of if one waveform loses efficacy, you can move on to the other waveform. So I think like fundamentally, it's about really improving longevity of therapy from an outcome standpoint. And if you don't have that, I don't believe you're going to have the type of 2-year data that we saw in our COMBO RCT, especially from a functional improvement standpoint. We also have fantastic patient satisfaction standpoint. One of the things that I didn't talk about that I am excited about is our partnership with IBM. And one of the things that IBM is really helping us understand is to provide physicians and ourselves better insights into pain patients and better insights into when they're at home, how are they doing long term. And in that partnership, we've actually created an AI-generated algorithm that using patient inputs can actually help us better understand and better manage a patient's therapy long term. So I'm excited about that. I think what is important, again, is you have to look at a patient holistically, not with any individual technology, but look at a patient holistically understand how they're doing long term. And again, if you can't personalize therapy in the long term, I don't think you're going to see that longevity of outcomes that's really needed in the space.

Thanks. Time for one more, Patrick, here in the middle.

Amazing. Thank you very much. Patrick Wood, Morgan Stanley. Two, hopefully, fairly, quick ones. I guess, on SpaceOAR the growth of SBRT over time, do you have a sense today how much is being used with IMRT versus SBRT? Like who the main customer base is? And as the growth of SBRT goes through, is that meaningful for that product? Just one quick one. And then ED, I guess, you've got a strong peer in that market with a good product, and they've been trying to push it to consumers, but the penetration is still quite low. No pun intended. To what degree do you think this is...

Welcome to our world. it's look like every meeting. I'll give it to Ron.

So I'll take the SBRT question. So it's obviously early with that technology, but there have been two large studies that you're probably aware of out of Europe, and it's becoming -- in Europe, it's growing very rapidly. So that's why our trial is being run in Europe. And we think that this is really going to help us have a leg up by having the only RCT data in the space in -- as you know, we have a new competitor. In the United States, it's growing a little, it's mostly at academic centers, not as much in community practice, or for example, the [ alpha ] groups, but that has more to do with reimbursement than any kind of issues associated with efficacy or safety. And that reimbursement is going to change. And when that happens, it's going to be almost like flipping a switch. And so we want to be prepared when that switch flips.

And then on the ED front, I'll say this. So -- and Ron pointed this out, ours is the only implant that has an antibiotic coating on it. Additionally, we have the broadest portfolio of both for prosthetic urologists who do both incontinence and ED. We can partner with them across all those needs. And I think when you see the investments we're making and how we're going to transform this market. And I think the way in which we're educating and activating patients is a -- it's a more values-driven approach to normalizing the conversation, humanizing the conversation, and it's not relegated into sort of ads and CD magazines. So I think that's what's going to really unlock the market opportunity here. We've been the category leader in this space by a pretty significant margin, and we expect that to remain the case.

Thank you, Meghan, and thanks to the MedSurg team.

Thank you.

Thank you.

Yes. There you go. Yes, I got to work harder. All right. Thank you. Thank you. All right. I'd now like to welcome to the stage Jeff Mirviss and Dr. Michael R. Jaff, representing our PI division.

Thank you, Lauren. As we switch to the Peripheral business, just a quick reminder, our business serves the vascular medicine specialist, vascular surgeons, interventional cardiologists and interventional radiologists. Looking at a vast highway of arteries and veins outside the heart and the brain and then many, many organs that we treat with the interventional radiologist. So let me share a little bit over the next 10 or 15 minutes with Dr. Michael Jaff, how we're going to continue to lead in this business and outgrow the market. We are going to eclipse about $2 billion this year and we've had a good history of growth above the market. And we see that continuing over the LRP. We moved a lot of our investments to high-growth adjacencies just like at Boston Scientific. While we're also acutely focused on accelerating our margins, we have four key growth vectors in Peripheral. The first is in drug elution for PAD; the second in interventional oncology, treating a variety of cancers; embolization, which I'll talk a little bit about, which is a high-growth space and area where we have some really interesting new innovations; and then in venous, which is one of the fastest-growing spaces within Peripheral right now. And we have made a significant investment in clinical science, with a really innovative approach that I think is differentiated in the Peripheral field, not only looking to deliver contemporary evidence with head-to-head trials and comparative evidence, but also unique platforms that can give us new insights into not only the safety and efficacy of our devices, but also the health economics data to support reimbursement and expansion. And then finally, we've globalized significantly, and we see huge opportunities to continue to grow in the emerging markets and in China and really everywhere around the world where our disease states are pretty low penetration. And so we look at the total addressable market in Peripheral at about $9 billion. This is $1 billion more than the last time we were together at Investors Day 2 years ago, growing sort of mid- to upper single digits. We break the Peripheral business down into these three different segments here. With Interventional Oncology growing high single digits, a served market of about $2.5 billion. We are the category leader here in Interventional Oncology. We actually have about double the market share of our closest competitor. And we're very focused on treating solid tumors specifically in the liver and in the kidney, and we're moving to other cancers as I'll talk about in a little bit. And we have several state-of-the-art embolization technologies, that are used to close down vessels for a variety of conditions. In the middle of the slide is arterial, which is the largest portion of the Peripheral space with a served market of about $5 billion, growing mid-single digits. And we recently attained market share leadership in the SFA in drug-eluting, with the combination of our state-of-the-art, Eluvia drug-eluting stent, and our leading Ranger DCB. And we couple this DE offering together with our leading core products in categories like bare metal stents, bare balloons, guidewires, atherectomy, et cetera. So that we can be the one-stop shop for our customers. And finally, we look at the venous market, which is roughly a $2 billion market, growing double digits. And we have a very broad portfolio in venous that's looking at treating disorders like pulmonary embolism, deep vein thrombosis and varicose veins. And so when you look across all of these therapies, we see a very underpenetrated market with tons of room to innovate and more opportunities to extend these therapies to more patients around the world. So let me shift to TheraSphere, which is the largest product within Peripheral. We look at TheraSphere as a platform technology and we see significant opportunities to expand and grow utilization of TheraSphere. We have line of sight on the right hand of the side to significantly expanding the TAM for TheraSphere from about $500 million today to over $3.5 billion over the next decade. And we look at TheraSphere as a way to deliver a very, very high dose of radiation to solid tumors wherever they may be in the body, while reducing the side effects and reducing any complications to the healthy tissue surrounding the tumor. So I mentioned that the TAM today is about $500 million. TheraSphere has been growing up double digits, and we see that continuing over the LRP. It is, in fact, the only FDA-approved medical device for primary liver cancer where we are approved in the U.S. And we're actually approved for all liver tumors outside the United States. So we have a lot of runway to continue that growth around the world. We're very focused on digital opportunities and leveraging AI to streamline the customer experience and to make the overall delivery and use of TheraSphere easier and more efficient for hospitals and for interventional radiologists. And we think that over the next couple of years, 3 to 5 years, we can double the current TAM from roughly $500 million to $1 billion. So how are we going to do that? Well, firstly, geographic expansion. In China, there are more than half of the world's primary liver cancer patients in part because they don't have -- has had much access to vaccines for hepatitis. So we see that as an opportunity for growth. We're working on bringing TheraSphere to China. We're enrolling in the clinical trial right now called MANDARIN, and we see that as a big opportunity to expand the TAM and grow our position. And we also see the opportunity to combine TheraSphere, a local regional therapy, with systemic therapy with immuno-oncology drugs. This is a newer class of systemic therapies, which have shown excellent results for patients, and we believe that a combination of immunotherapy plus a local therapy of TheraSphere can provide improved efficacy for primary liver cancer. And then beyond that, beyond the LRP, we're aggressively working on bringing TheraSphere to new cancers. And we think this will unlock multiple billion dollar market opportunity and really help patients that have poor outcomes today in a couple of different cancer beds. The first is in brain cancer and in glioblastoma. We're currently enrolling in a trial called the FRONTIER study. It's a safety trial. And assuming that goes well, we'll then move on to a pivotal trial to get approval for TheraSphere in brain cancer. And then next year, we'll be starting a safety and efficacy trial called the VOYAGER study, which will look at TheraSphere in advanced prostate cancer. So both of those over, say, the next 5 to 10 years, I think, will give us an opportunity to take this platform technology and extend it into other cancers in the body. But wait, there's more. In interventional oncology, we're very excited about our journey to be the embolization category leader. This is a $1 billion market that's growing double digits. So we see it as very attractive. We play in it today. This is interventional radiology space, where interventional radiologists go into block off blood supply to either arteries or veins. And there are many different clinical uses for products like this, but they're typically used to shunt the blood supply to a tumor benign or metastatic tumor or in blood vessels like in the case of an aneurysm or a bleeding vessel like a GI bleed. We launched earlier this year, the EMBOLD fully detachable coil system, and it will be available in three versions. And this is giving us excellent growth. And we will launch line extensions to the first EMBOLD here in the next few months and throughout 2024 globally. So we see this as an opportunity to extend leadership, take share and grow our embolization business around the world really over the next several years. And on the right-hand side is a new category of embolic that's called OBSIDIO. This was an acquisition we did about a year ago. It's a unique and differentiated technology that allows doctors to experience near immediate occlusion of the vessel, which is a critical feature in emergency situations, like I mentioned, GI bleed, or in a trauma type of situation. And the OBSIDIO Conformable Embolic eliminates some of the downsides with today's technologies like in liquid embolics or in glue, which is used in many of these procedures. So we see this as a really differentiated technology, something that solves some really important unmet needs for customers and patients. And to give you a sense of how easy this is to use and how quick it is we created this video for you. So let's roll the video and give you a sense of how OBSIDIO works. [Presentation]

My favorite piece of feedback from our customers on this because we've done some cases earlier this year was this is a game changer. So we're excited to introduce this -- later this year and then over the LRP in other geographies around the world. So let me switch quickly here to the vascular business. We're executing our category leadership strategy. We are the clear leader in the SFA in DE. And we recently launched the Eluvia length 150-millimeter stent. So this has been helpful for physicians and for hospitals. And we were very pleased to see the FDA lift any warnings on paclitaxel 5 years later, with tons of data and a lot of collaboration across industry and FDA and physicians. It was great to see that. We think this will be an excellent tailwind for years to come because the adoption rate actually in Peripheral drug-eluting is quite low. And so we think this will help to lift adoption over multiple years and globally. And on the venous side, we're investing to capitalize on a variety of high-growth opportunities, while expanding our leadership in chronic venous insufficiency. So the product they're called Varithena. That's a minimally invasive chemical ablation for varicose veins. It's an established category leader with growth that's been double the market rate. It's a highly differentiated technology, and it's really been appreciated and, frankly, preferred by patients as it provides a very quick procedure without the need for any tumescent anesthesia, and no pain that's associated with heat-based thermal procedures that are used today. So this has been a really good growth driver in our venous portfolio. And we're investing significantly in clinical evidence for EKOS in PE to really challenge the status, the standard of care, which is, as you know, anti-coagulation. And so we believe this will be a huge opportunity to improve outcomes and demonstrate that EKOS is an optimal choice for patients. And finally, we are completing the early access for WOLF products in venous thrombectomy. And we may choose to launch the WOLF products next year, pending feedback on this EA, and we'll certainly keep you posted as that transpires. So let me introduce Dr. Michael Jaff, who will take us home. Michael?

Thank you, Jeff, and good morning, everyone. We've demonstrated previously our commitment to giving physicians the day-to-day need to make the decisions to manage their patients as they're facing them. We started out with the IMPERIAL trial, the first-ever prospective multicenter randomized trial of the Eluvia drug-eluting stent versus the only other drug-eluting stent on the market. That trial showed superiority. We followed that with the EMINENT trial, the largest industry-sponsored randomized trial of Eluvia versus any bare metal stent that physicians want to choose, and we showed superiority in that. We have similar data sources on the Ranger Drug-Coated Balloon with COMPARE and independently run randomized trial against the market leading at the time, drug-coated balloon, and we showed excellent results and the RANGER II study. Well, our commitment to data to demonstrate our commitment to our products and our doctors continues. Just a few months ago in Japan at a major international meeting, notable Japanese investigators independently ran head-to-head trials of our RANGER Drug-Coated Balloon against other drug-coated balloons, and we continue to show excellent results in complex real-world lesions. Later on this fall at TCT in San Francisco, we're eager to see the results of an independently run prospective multicenter 3-arm head-to-head study. This was a study of Eluvia versus another industry competitors drug-coated balloon versus bare metal stents. That head-to-head trial in long complex lesions will be presented at TCT, and we're eager to see the results of that. We certainly, as Jeff mentioned, are committed to giving physicians finally the data they need to tell their colleagues that anti-coagulation is not always the first and only treatment for patients with pulmonary embolism. The HI-PEITHO trial, the first-ever done prospective multicenter global randomized trial of EKOS versus standard of care anticoagulation run by world-leading investigators has enrolled rapidly, far better than many skeptics thought and we look forward to the results of that trial as it continues to enroll. And then finally, the ELEGANCE registry. This platform registry using Eluvia or Ranger, physician's choice, up to 5,000 patients globally where we committed before we enrolled the first patient, that 40% of the population would be women and 40% underrepresented minorities, two populations who are afflicted by PAD commonly, but are rarely studied in clinical trials of large scales. We're going to be able to provide information that the field has not seen from the results of the ELEGANCE registry. As of today, we are well ahead of our targets in both of those subgroups and the total population, and we'll look forward to opportunities to even consider a label expansion for our products. So we're excited about evidence generation. You heard our commitment to expanding to bring our impactful therapies globally because of the increasing growth rates in emerging markets in China, and you'll hear just a moment from the China leader about that. We are really excited about these technologies and we're very interested in being able to take these technologies to patients who need them. We are excited about the partnership with Acotec. This investment announced earlier this year will allow us to get insights into China, will allow us to be a global distributor, the only global distributor of Acotec products outside of China and help with our commercial skills to bring those products outside of China to around the world. The portfolio of the two companies are quite complementary and certainly, will allow us to fill some holes in portfolios around the world. So this is a great opportunity for us. So as I stand here with you this morning and wrap up, I can tell you as a clinician who's practiced in vascular medicine for a long time, we actually, in our division, speak to the core of this company of advancing science for life. We commit to data. We take our products directly where they need to be studied and we provide answers for clinicians. And we take innovation that will change lives. What's happening with TheraSphere is truly transformational and we are excited about the future. And with that, I will introduce June Chang, the President of Greater China. Thank you.

Thank you, Dr. Jaff. Good morning, everyone. I'm June Chang, President for Greater China. So happy to be here. So in the next 10 minutes or so, I wanted to cover -- talk about the China -- our business in China, give everybody an update on what's going on and given the dynamics, and most importantly, I want to share with you why we believe that we will continue our momentum in China. And we continue to see China as a very attractive and faster growth market globally and most -- one of the most attractive markets with this unmatched growth opportunity. Of course, the market is growing, getting increasingly complex. When we look at some of the underlying fundamentals, it hasn't really changed much, aging demographics, significantly unmet patient needs, demand for high-quality medical solutions, and most of all, we see more and more doctors practicing learning and adopting minimum invasive therapies. And for BSC China, we've been playing a critical role in teaching and educating and helping those doctors to run new therapies, and we continuously view China as a very, very important market for us to grow to innovate and to serve more patients. Now certainly, the growth pathway in China is getting, as I said, increasingly complex. And when you talk about the dynamics, the payment reform, the reimbursement scheme, you talk about DRG, VBP, it's tough. And you talk about the increasing local competition, and those competitions are getting sophisticated. And we're seeing local players are launching new products at an incredibly fast pace. And when you talk about some of those local policies, yes, there are policies that favor a little bit about local sourcing, local manufacturing. So when you put those two pictures together, what does that mean for Boston Scientific China? I think it just means that we need to act as a business a lot faster and a lot smarter. So today, operating in China is not only about capturing the upside growth potential, it is also about keeping our eyes right open and looking at tackling those challenges and mitigating those risks. So that's why I'm here to talk about what is the China thesis going forward? I think the China thesis for Boston Scientific China is summarized in three key principles: speed, we got to be faster. We are bringing new products to China a lot faster than our competition; localization, it is so important to help us keep us stay in the game; and last but not least, the scale up, scale-up allows us to drive leverage and continue to drive profitable growth. By doing all those things, we firmly believe that will be in a strong, strong position to take this business to the next level of high performance. So let me just give you a quick snapshot of where we are in China. We've been on a remarkable growth journey for the last couple of years. Even with the pandemic, we've been growing very high double digit, and we're on track to exceed $1 billion next year. And in our LRP time horizon, we will continue to deliver double digits -- mid-teens, double-digit growth as well as with an attractive margin to our bottom line. We continuously benefit from our global collaboration and our portfolio strength as well as our strong, strong commercial capability that we've been able to build over the years. When you look on the right-hand side, our portfolio right now is actually very well diversified, and there are two things I want to highlight. Number one, I think our portfolio is now pivoting more towards the high growth, high profitable portfolio. And then number two is that we actually have been able to manage some of those VBP exposure by really leveraging the breadth and the depth of our portfolio, taking advantage of some of the market access opening and allow the drive-through of our entire portfolio suite. Now as I mentioned, why we believe that we will continue to win in China. I think there's three strategic imperatives that we have done well, served us well and we were going to continue to do that. I talk about accelerated product launch. We have a stellar impressive lineup of new product launch in the next couple of years. We know speed to market extremely important in China. That's why BSC China has always been at the center and the forefront of championing new registration pathways of accelerating our product launches in China. We've actually been granted the largest number of approvals to first trial our products without getting the NMPA approval in Bo'ao. We've also got a lot of products in green channel, including Farapulse. We've had initiated some new progress in Grand Bay Area zone, and all those efforts are trying to get the products to China a lot faster. Now I said localization is so important for us to stay in the game. For BSC China is not only about the manufacturing, it's about tapping into the local ecosystem and really sourcing new ideas, new innovation, collaborating on product development, doing deals, looking at the business model innovation. I'll give you a couple of examples of how we do develop in China for China product like thyroid nodule product, which has a significant amount of patient needs in China. We've also recently received the first NMPA approval for our locally registered capital equipment for our imaging business. We've acquired a major stake in one of the public traded company, Acotec, as mentioned by colleagues in PI. And we're constantly looking for local partnership, distributing products from local players that are highly complementary to our portfolio so that we can offer a more comprehensive and total solutions to our customers and patients. As I said, success in China right now is all about the operational resilience and excellence, and this is where I want to touch -- highlight about some of our talent and capabilities. You hear from Art talking about this digital capability and how we drive synergy around the world, I want to highlight a couple of things in China that we do because it is so important as we scale up our business. This is one way of how we help drive operational efficiency, improve productivity and drive cost out of our system and continue to leverage. A couple of things. E-Workflow is actually our entire business management process engine. We bring everything process online right now. It's highly efficient, transacts huge tons of volume. IConnect is a turnkey solution that we developed in-house. It's a very compact mobile device, which connected different cath labs. What it does is allow us to do more product to ship remote training. And it's very, very important because as you hear me saying that as we expand our commercial footprint in China, we're covering more and more hospitals, and especially those hospitals in lower tiers and rural areas. So those remote training device allow us to do that in a much bigger scale, but at very economic way and efficiently. Omnichannel is another interesting mobile app that we developed in China, which allow us to connect with our HCPs in a more personalized and customized way. Right now, we have about 7,000 cardiologists sign up for that mobile apps allow us to constantly connect with them, both online and off-line. You hear our CEO talked about the people is our most important asset. In China, we're always very proud of having our team young, passionate, committed and we have a group of seasoned executives in China well grounded in the local insights, well grounded in the local networks, and we are very, very proud of this team. We have a proven track record of navigating through some of those complex systems, and we continue to believe that we're in a strong position to win. So a quick recap. We know the China playbook has changed and will continuously evolve very rapidly. We know that it's not an easy market to play, but it is a compelling market. So we stand firm our commitment, but we're constantly recalibrating refreshing our approach to maximize our potential and to focus on our core, focus on our highly differentiated product, technology, and we continue to find new ways to grow. And again, we believe we are in a very, very strong position to win and we have the best team on the ground to deliver that. So with that, thank you, everybody. I'm going to invite Jeff and Jaff.

Thanks, June.

Thank you.

Terrific. Thank you.

All right. We will be opening it up to Q&A for the next 10 minutes with our PI and China team here. We'll do Travis right here in the front.

Maybe just give us a little color on what's going on, on China, kind of things have changed a lot in the last month, and it seems to be changing rather weak. From like a procedure standpoint and capital standpoint, I know you guys don't have a lot of capital. But maybe just given you're pretty close to China, I would love to have that view. And when you think about being more local, just kind of how you think about developing those products more locally and protecting the IP around it and stuff like that?

Thank you. I think the first question is really talking about the anticorruption campaign, right? It certainly has been the center topic in the last month also since the industrial announcement on July 28, it gets a lot of attention. We certainly have observed some kind of a slowdown in the procedure volume and the physicians are doing less over time. That happens. We also have heard that the big capital equipment are getting a little bit difficult to get the hospital listing, getting into the hospital. But I would say that for our business, we feel in the short term, there will be a little bit of disruption. As I mentioned, with regard to the procedure volume, but it's very manageable. And in the long run, we believe that BSC has a very strong compliance culture, and we have very comprehensive policies and product codes in place. And we think that with that campaign and it happened in the history a couple of times in the past, the business will come back very strong, and we continue to believe that it will benefit the business over the long run.

Can procedures still grow through this campaign? I know you said procedures are being impacted a little bit near term. But how should we think about the impact? Is it like a small impact or is tending to decline? Still grow? I think I noticed the comments on China were more mid-teens. And I think in January, growth in China was 20%. So I don't know if that delta is the difference or maybe I'm misremembering?

We grew 20% in 2022 and said the outlook was mid-teens for 2023 and beyond. So no change there, but...

Right. I would add a little bit of comment to that. I think for our long-range plan. And when we do our business planning, I think it's a function of a lot of different factors, including some of the VBP impact some of the macroeconomic conditions. So you see us dial down a little bit from a very, very high double-digit growth to mid-teens. You're absolutely right. And I think that's taking into consideration some of the dynamics that are happening in China. But overall, as I mentioned, the procedure volume growth is still significant and compared with the rest part of the world. And when you look at the PCI growth, PCI overall procedure volume in China already surpassed the U.S. this year and it continuously grow double digit. I think that had a lot to do with the improved affordability. So that's something that you have to -- when you read into some of those VBP, hopefully, you could get beyond a little bit of those hyperbolic headlines and they're really looking at some of the underlying trends. I think it's still demand is still very strong.

Thank you. Do, Anthony. Thanks.

Anthony Petrone, Mizuho. Maybe just to stay on China for a moment, June. One of your competitors talked about how if products were already in the VBP program, it would potentially sort of hedge them out from anticorruption risk. So maybe a recap on what percent of Boston's products already went through VBP. How many still have to go through it? And do you agree with that statement that it hedges you out from anti-corruption correction? And then I have a follow-up on TheraSphere?

Yes. So it's two different topics, right. One is VBP, one is anticorruption, as I mentioned, I think I answered that question about the anticorruption. We see it as a very short-term impact. And in the long run, it will help. I think it is fair to say that in the next -- in the -- in recent days or weeks, as I mentioned, what we observed is there's some slowdown in hospital listing for new products. And that probably echo back to your early comment why some of the competition is mentioning that for new products to getting it, it's difficult. But for VBP products who are already in the hospital, the exposure seems to be manageable, right? Now your question about, in terms of VBP and which part of our portfolio is getting exposed? I think it's -- VBP is a very complex topic actually in China. And the reason it's being complex is it is -- it doesn't have one formula, right? Going from a national VBP to a provincial VBP, it's a tremendous variety to the different schemes. So when you think about the VBP, it's a patchwork of different schemes and different policies. So if you talk about the provincial side. Therefore, every VBP, the number of geographic coverage could be different. Sometimes it's 10 provinces -- provincial VBP. Sometimes it's a 5 provincial VBP and the price impact that the rules sometimes is also very different. Some are less extreme. But I would say, over the course of the last couple of years, what we've seen the major trend is first of all, the pricing part impact on VBP is getting more moderate, more rational. And the second piece is, it is very, very important when you have an entire portfolio, i.e., you're not being sort of having only one card in your two box, and that becomes very challenging when you are facing the VBP scenario. But for BSC, we continuously believe that we're in a very good position that we're actively managing VBP because we have the breadth of portfolio where we could create a lot of bundled solution to win those tenders. And the second one is our commercial footprint. Frankly, that is also very important. Even if we win the VBP, you're going to start to see your coverage started to open up, but you need a strong commercial capability on the ground to service because it's essentially a contractual obligation among the government, the hospital and manufacturers. So it is very important that you have that commercial capability on the ground. And so that hopefully gives you a little bit of favorable what's going on.

And just a follow-up on tariffs here. Just the combination therapy approach. We're aware of the ROWAN study with AstraZeneca. And just is that the key study to unlock the combination therapy approach or are there other ones we should be looking at?

Yes. Short answer is yes. That's the key 1 for us. There are a number of trials going on ISRs and a lot of interest in this area. So I think over time, there will be a lot more data to come. But the one we're focused on in partnership with AstraZeneca is the ROWAN trial.

Matt, right here. There you go, teamwork. Thanks.

Matt Miksic from Barclays. So I had one question for -- on Interventional Oncology for Jeff on the growth rate that you put out there that sort of double-digit growth rate has been growing, expected to continue to grow. But doubling the market in the next 5 years. Maybe just focusing in on the MANDARIN study that you mentioned. Can you give us a sense of how important that is to sustained growth of that business? Or is that upside to that double-digit trend? And then any color as to what we can expect in terms of the time line for data approval, et cetera?

Yes. So in short, the MANDARIN trial will help us get into China, that will unlock a big market that sort of really doubles the opportunity for us. We're well on our way with the trial. So it's enrolling and doing well. My double-digit comments, that certainly unlocking China is a part of it. But around the world, TheraSphere just continues to grow well and is supported in many countries. And there's other geographies that will continue to expand geographically as well.

The time line for China access approximately?

I don't think we've mentioned specifically, but I would say over the LRP period. We're enrolling the trial now so you can sort of do the math on how long it takes to get in.

And then one follow-up for Dr. Jaff, if I could, on agents coming up at TCT. Maybe give us a sense of what are the expectations? How important is some of the clinical data? What the appetite in the community is to have a balloon in the coronary as opposed to currently only in the periphery?

Yes, thanks. This is a good hand off. You're going to hear all about this from Joe and the team in cardiology, so I'll let them do it. I will tell you that there's data that I mentioned and others on the PI side that we're very excited about at TCT.

Yes, thank you. Marie, last question for this session.

Marie Thibault, BTIG. Maybe a question for the peripheral vascular side. Encouraging to hear that enrollment in HI-PEITHO is going rapidly. Any time lines around that? And is the intention that, that study will be enough to sort of change guidelines, change practice more widely? And then as a follow-up on WOLF, I think it was an acquisition that was announced just before the '21 Investor Day. Is the plan to still go ahead with the PE effort there, pulmonary embolism label there? And any feedback you're hearing so far on potential changes or tweaks to the product?

Thank you. So Lauren, have we given time lines on HI-PEITHO completion?

Only what's on clinical trials, which I think is 2024.

Yes. So we're excited. I think the pace has really ramped up. Listen, I absolutely believe that there are multiple ways to take care of sick patients with pulmonary embolism. It's not all mechanical thrombectomy. It is not a free pass. EKOS provides the most data across the entire portfolio of pulmonary embolism patients, and we're excited about what HI-PEITHO will show. You want to comment on WOLF?

Yes. On WOLF, with the Devoro acquisition a couple of years ago, it really was a portfolio of products. And so as we've integrated the technology and got into early access, we want to be careful that we ensure we bring to market a product that's high performing that can be unique in the marketplace. And so right now, we're very focused on the DVT versions. Actually, there's multiple products within DVT. And I think job 1 is to figure that out, and we'll assess if we launch it next year. Once we get through that, then we will assess what could potentially be after that, which would possibly be PE.

Thank you so much. We're now going to go into a 10-minute break, so we're going to promptly start back here at 10:55 a.m. Eastern. Thank you. [Break]

All right. I am very excited about the first part of our session today and I'm really excited about the second part, which is largely our cardiology business, and we'll end the day with finance. So without further ado, I will welcome Joe Fitzgerald to the stage to kick off cardiology.

Thanks, Lauren.

Thank you, Joe.

Thank you, Larry. I'm really thrilled because we've obviously maxed out on VBP and China questions. So that will leave more questions for Nick Spadea-Anello and the Farapulse team. So we got that out of the way. But good morning. Thrilled to be here to help intro the cardiology plan. I've been with Boston Scientific 30-plus years, and I've spent time in each of these cardiology divisions. Tried multiple times to get into MedSurg, but I can't get past the final interview techniques of Meghan Scanlon. But that's my career goal, Meghan, is to convince you I can join. Okay. So let's start off. I wanted -- before I get into the slides, Mike mentioned the importance of people first and then innovation. So I just want to intro, you're going to hear from 8 of our cardiology leaders today, 7 of those eight people are in new jobs or larger, more complex jobs than they were 2 years ago when we had an Investor Day in 2021. The average tenure of that team with Boston Scientific is 13 years. The average tenure in the med tech industry is well north of that. So the leadership team, I'm really proud of, they're tenured people, most of them are new and bigger jobs to help us drive our strategy. So with that, let's talk about sort of the overview. So I won't go deep into this, but clearly, cardiology markets globally, we'll round out this year at about $35 billion. The sum of all the different things you're going to hear from the different leaders is a view on market growth of about 7%. And I think the major headline, and I'll tell you how we're going to get there in a second, but the major headline for the cardiology group is we aspire in this long-range plan and then beyond that, to significantly grow faster than the end markets that we are in. And hopefully, you're convinced of that by the end of our presentation. So we do that, obviously, as I said before, with our people, but we also do it, and it's really the playbook that Mike talked about. So we drive our innovation through internal R&D. I'll make a comment on that in a moment through tuck-in highly strategic acquisitions that drive category leadership. And then thirdly, through our VC portfolio and our partnership portfolio. So as you look at how we put all 3 of those things together over the past multiple years and multiple investor days, we will now look at a business, a $6 billion business, today that will be much larger over this long-range plan that will have probably around maybe north of 50% of that multibillion-dollar collection of businesses in those high-growth markets that you saw in Mike's slide. We have the low growth, the moderate kind of core growth and high growth. So 50% of our portfolio will be in the high-growth segment when you look at how we exit 2026. A couple of examples on that. If you look at internal R&D, where we spend in cardiology greater than $600 million, is our relentless pursuit of continual innovation. Two examples of that, that I'll point out, and you'll hear this from Lance and from Angelo. First one is DES. So you go back about 6 years, about 3 investor days ago, we were talking all about our belief in the SYNERGY stent platform. And over the past, call it, 6 years, you've seen us launch SYNERGY XD, Megatron, and you just heard that the agent drug-coated balloon will be presented at TCT as a late breaker. Great examples of how we don't rest on our laurels. We drive category leadership, and we never pull up and say, let's just harvest that big category of drug-eluting therapies. The other example of that is WATCHMAN. So the WATCHMAN team, where we got approval in 2015 set a goal that we're going to develop the next-generation WATCHMAN and deliver it before we get our first competitor in the United States. You see that then with WATCHMAN FLX being approved in August of '20. And now you see it again with the WATCHMAN FLX Pro that you'll hear more about today. So that's -- those are 2 examples of how we just don't rest. We never arrive. We continually take that internal R&D and demand innovation from our teams. Second one is our VC portfolio. There are 2 great examples of that criterion, which became our POLARx launch that just got approved. That was an internal program that we externalize to get it to move faster and then we brought it back in after the early clinical data. The other one, probably -- another good example is FARAPULSE, where we invested at the very early stage [ seen ] continue to invest and support the company and bought them early so that we could scale the business. Now next point, and I -- I need to explain this a little bit because any time you put -- disrupt an $8 billion market. So I'm talking about our transformational EP opportunity. And you see the word disrupt, I need to explain that a little bit. Because clearly, today, we have a fourth place EP business, and we're putting on a slide at Investor Day that we have the opportunity to disrupt that $8 billion market. So you're going to hear a lot from Brad Sutton, our Chief Medical Officer in AF Solutions and Nick Spadea-Anello about this, but a couple of things I want you to keep in mind because I've had questions from this group about the team. So -- which is very, very appropriate question. So in the past, think of it, we've had dozens of people running our EP strategy and executing our EP strategy in a market like the U.S. Today, we have hundreds of people preparing to disrupt the EP market because we've merged our WATCHMAN, our Baylis and our EP commercial teams in the United States into an [indiscernible] solutions. You're also going to hear or I'm sure we're going to hear from you, questions on supply chain. I will tell you exactly what Mike said is why we bought FARAPULSE early in August of '21. It was because we knew we had to develop a supply chain. So sure, we'll get some questions on that. I don't stay awake at night based upon our supply chain because it's something Boston Scientific does really well, especially when you have a 2-year head start. And then thirdly, you'll hear from Dr. Sutton on our clinical experience, so I won't go into the ADVENT trial, but I just want to put into context for you why we are so confident in our FARAPULSE platform. Number one, we've been on the market greater than 2 years in Europe. We are approaching nearly 200 accounts in both Europe and Asia. We've treated more than 25,000 patients, and we've demonstrated a very fast learning curve, a very consistent safety and efficacy and efficiency profile. And we've done it multiple times over and over again. That's to date. And then what you see, and I think Mike mentioned this, you'll see us rapidly ramp the biggest -- the current biggest PFA market in the world, which is Europe. You'll see us make tremendous strides from this meeting until probably Q4 earnings call and Q1 earnings call, you'll see a dramatic increase in Europe. That's why we're positive that we can disrupt the EP market and be leadership -- in a leadership position in PFA. You're also going to hear a lot from our CT, structural heart and WATCHMAN teams about 2 things, about their clinical portfolio, driving innovation there, our product portfolio. You'll hear some about our partnerships and the actual way will drive above-market growth and sustain the market growth in WATCHMAN through market development. You also -- and I -- pay attention that Lance has got a great look see into this whole VC portfolio, early-stage internal bets and partnerships into this area that we broadly call interventional heart failure. So you'll get a really good overview of how we think, and it's in that call it, interventional cardiology, interventional heart failure team. So we're super excited. The rest of it comes from our leaders, but I'll close with this. Many, many Investor Days, when we put up a slide like this, you're talking about things that don't quite make it into the long-range plan. Are there something that just completed their FIM or their EFS and we're super excited about it, but you got like a 6-year journey. The big difference in our cardiology strategy now is many of the things that you see on this slide that really define how we're going to grow well above the 7% cardiology market growth. Are already in Europe. They've been there for years. They've already completed their clinical study i.e., ADVENT that was just presented. You'll see the AGENT data at TCT. So it's first time, at least in my career in cardiology that we sit here and what dominates our long-range plan are things that are well deep into what you call the new product development and clinical development portfolio. So I'm not going to steal anybody else's thunder. But with that, I want to introduce Ken Stein and Scott Olson to come up and take us through our CRM and diagnostic strategy.

Thank you, sir. All right. Good morning. My name is Scott Olson, I'm responsible for the CRM Diagnostics division of Boston Scientific, and I'm joined by Dr. Ken Stein, Chief Medical Officer for Boston Scientific as well. We are really excited about where we're going with CRM Dx and as we look at this, I am honored and proud to lead a diverse, passionate and committed team in this space, a highly competitive space that it takes a lot of effort to win and a lot of focus, and we're absolutely up for it. We will deliver at or above market growth in CRM in this highly competitive market with a very differentiated offering. And that is really the key to our opportunities going forward. In our Diagnostics division, we will exceed market growth rates. By taking share in Diagnostics with a couple of new product introductions you'll see within our ICM space as well as our wearable technologies. And we will continue to focus on the $4.8 billion high-voltage market, where we're a strong #2 today and some nice pipeline catalysts to accelerate our growth within that space. And we know it's important to get into additional markets and high-growth adjacencies. And Ken and I will spend a little bit of time on those opportunities as well. As we look at the markets we serve, it's a little -- it's right around $11 billion potential here. So it's a very large market. And we break this up into 2 sections within the division that I have the opportunity to lead. Cardiac Diagnostics, and this was a -- actually part of our division that didn't exist a few years ago. This is -- this is the Preventice acquisition, it's in insertable cardiac monitors. And in this space, we will capitalize on a complete portfolio from AECGs, a wearable technologies to our insertable cardiac monitors and diagnostics are a very important part of our strategy, and we are committed to leadership in this space. As we think about this, we talk a lot about in the division here, the opportunity to diagnose, diagnosing arrhythmia, treating arrhythmia and monitor. And this is something that Diagnostics brings to not only cardiac rhythm management because doctors can lead to a pacemaker, a defibrillator, a CRT-D, or even an S-ICD, but they also lead to electrophysiology cases and WATCHMAN cases and maybe monitors post-structural heart cases. So as we think about Diagnostics, it's not just a division within Boston Scientific that I get to lead. It actually crosses all of cardiology that Joe leads. And that's why we think it's such an important part of our business here. On the CRM side, I am proud to say we have a highly competitive and differentiated portfolio within this very large $8.5 billion space. And it will drive us at or above market growth. We provide physicians both transvenous options within the brady business or the pasting business as well as the tachy business as well as subcutaneous options or extrathoracic options with our EMBLEM S-ICD. That opportunity continues to be a differentiator for us in this market. And we also know we have a very unique algorithm called HeartLogic. The only proactive remote alert proven to provide early signs of heart failure decompensation and that opportunity to reduce hospitalization moving forward. That's something that if we can get across our product lines. We now have them on our high-voltage lines, and we'll talk a little bit about how we can get that on to our Diagnostics monitors as well. So let's start with the cardiac diagnostics pipeline. This is a broad and differentiated pipeline or -- pipeline -- or even offering today with highly competitive products in the large and growing arrhythmia monitoring market. Our portfolio will only get better with the addition of BodyGuardian UL and LUX-Dx II. Now the good news is LUX-Dx II was recently approved, LUX-DX II and LUX-DX II+, a couple of different tiers for us. And we expect BodyGuardian UL to be approved later actually into '24. So sometime in '24, we expect that approval. Now what's super important about the LUX-Dx II approval is it does allow us to have a bifurcated strategy. Today, in the ICM market, we have 1 offering. And that's challenging when you get into the high tech or the premium tiers and you also have to compete in the value tiers with 1 product, you're a little bit exposed there. Moving forward, we'll be able to compete in both with a highly differentiated, highly competitive insertable cardiac monitor. And that's a super important part of our strategy as we grow this Diagnostics business. But we won't stop there because we do believe we have an opportunity, as I said, to add HeartLogic onto a diagnostic and really impact this large population of patients and physicians looking for a better solution. Ken, maybe give us an update on that.

Yes. Thanks, Scott. So let me expand a bit on the opportunity. We see in heart failure diagnostics and taking the same diagnostic features we have in our ICD, CRT-D devices, HeartLogic and enabling them in a LUX-type form factor. We are well into enrollment in a trial called TRENDS. TRENDS is a 2-phase trial. So the first phase of TRENDS is designed to just prove that we can take those same 5 different physiologic sensors that make up HeartLogic and enable them in a LUX-type form factor. Then we'll follow that up with a Phase II. And in Phase II, we intend to show that, again, just as we did with our ICDs and CRT devices, use AI to combine those 5 sensors and provide an alert ahead of an impending heart failure decompensation. We're really excited about TRENDS and excited about the potential to address what is a significant unmet market need and a significant unmet clinical patient need. We also appreciate that both the U.S. FDA and CMS see this potential. This product is part of the FDA's breakthrough device program and has been included as part of their total product life cycle advisory program. Product is also part of CMS' TSAT pathway. Let me turn it back to Scott now to talk through our CRM pipeline.

Very good. Thanks, Ken. So as I look at our CRM product line today, I have to tell you, I'm extremely proud of it. We have a subcu ICD -- subcutaneous ICD, extrathoracic. You'll -- hear to call a lot of things, the only 1 on the market to give physicians the option to keeping [ leads ] outside the heart. But if you want to go transvenous, our differentiated technology within our RESONATE family of ICDs, CRT-Ds, provide not only industry-leading longevity, industry-leading lead reliability and also HeartLogic. And this is really an opportunity for us to continue to diversify and show physicians the options they have with our company. And I will say that EMBLEM S-ICD continues to be very differentiated. It's the only commercially available defibrillator that is placed entirely outside the thoracic cavity, avoiding serious complications that may arise during more invasive approaches underneath the ribcage. So we feel like we really have an opportunity here to expand and grow our business. Another area that I'm sure you've all heard a lot about is conduction system pacing, and we are going to continue to be very focused in this area. We have a good product line right there today, not only with our ACCOLADE pacemaker, but with our INGEVITY lead and our site selective pacing catheters to get physicians exactly where they need to be or want to be. But we're not going to stop there. We've made big investments to make sure that we are heavily invested in this market, and we are very competitive in this market, knowing where it's going. We also will talk a little bit about our leadless pacing as well as our next generation high-voltage and low-voltage devices. I'll hand that to Ken to let him do that. Ken?

Yes, yes, Scott, after FARAPULSE. The next thing my colleagues want to talk to me about is conduction system pacing. And so getting expanded labeling for INGEVITY + pacing lead to include left bundle branch area pacing is at the top of our priority list. We've already conducted extensive engineering analysis, presented some of that data at the Asia Pacific HRS meeting just a month or so ago. And additionally, we're conducting a real-world evidence study to collect safety and efficacy data for regulatory submissions expect to approve regulatory approval for that expanded labeling in 2024. And finally, we intend to include our devices as part of the large [indiscernible] sponsored Left versus Left after randomized clinical trial. And to remind you, left versus left is a very large clinical trial designed to test the comparative effectiveness of conduction system pacing versus traditional biventricular pacing in patients who have traditional CRT indications. Beyond getting that expanded labeling, we're also focused on improving the conduction system pacing implant experience for patients and for physicians. We want to meaningfully improve the conduction system pacing workflow and we'll be offering expanded options to enable more precise lead placement when you're doing conduction system pacing and expand the programming options available to physicians for optimizing outcomes with patients. Beyond conduction system pacing, [ we ] do need to talk about our next generation of devices. And we continue to make really extraordinary progress on our next-generation implantable device hardware platform. And that platform is going to result in new product introductions across our entire suite of implantable devices, pacemakers, defibrillators, including the S-ICD and our CRT devices. The entire platform will have more memory, more processing power as well as Bluetooth wireless communication and will support a wide range of differentiated remote programming capabilities. We expect to submit the first family of these devices from the platform to regulators in '25. Turn it back now to Scott to talk a little bit more about EMPOWER.

You bet. So as we think about this platform, and we talk about S-ICD, we call it modular systems from mCRM. And why is this important? As we know with EMBLEM S-ICD, there are multiple independent randomized controlled clinical trials, confirming the benefits of S-ICD. And this therapy has helped to treat over 120,000 patients worldwide. But we're thinking about it a little bit differently as well. We know some physicians when they think about starting with an S-ICD, may in the back of their mind, say, what if the patient develops a need for pacing or ATP. That sits out there. We recognize that we will go after that opportunity with EMPOWER. So EMPOWER will be our first leadless pacemaker into the market that can not only provide bradycardia support for those patients that need it, but also provide ATP and communicate directly with our S-ICD. We're working our way through that trial, and I'll have Ken give us a quick update on that as well.

Yes. Scott, I'm really thrilled with the progress of the ongoing trial, modular ATP. So that's our IDE trial, it's designed to get us approval of the EMPOWER leadless pacemaker both as a stand-alone brady pacing device but also as a device that can be used in concert with the S-ICD to provide anti-tachycardia pacing or bradycardia pacing if the patient develops a need. And I want to remind all of you that our current models of EMBLEM and EMBLEM MRI devices are all backwards-compatible with the EMPOWER leadless maker, meaning that our entire current installed base of patients with the EMBLEM S-ICD will be capable of having modular therapy once we get the leadless pacemaker on the market. And we expect the results of the modular ATP trial to be available in 2024. Scott?

Great. And I'll close with this where I started. We are a competitive team and we're excited to win in this market. We will deliver above -- at or above market growth in CRM. We will outpace the market in Diagnostics, and we'll focus on winning in high voltage. That is our strategy moving forward. We're excited about where we are. We're really excited about where we're going, and I thank you for your time today. Now I'd like to introduce to the stage, Mr. Angelo De Rosa, the newly appointed leader of our WATCHMAN franchise as well as Dr. Brad Sutton. Thank you.

Thank you, Scott.

Yes, sir.

Good morning, everybody. It's truly a privilege to be here today. My name is Angelo De Rosa. As Scott just said, I'm really just recently appointed as WATCHMAN leader. So maybe I'll say this is my first Investor Day. So I'll spend just a couple of words of introduction. Originally Italian, spent 20 years in Switzerland and just 3 weeks ago, I relocated in beautiful Minnesota. So that's number one. Number two, I have been 25 years in the medtech space and joining Boston Scientific 9 years ago, and I had the privilege to lead our rhythm management team in Europe, Middle East and Africa. At the time, they introduced a lot of great technologies starting from CRM DX and more lately, some of the disruptive EP technologies that Joe mentioned, so like POLARx in 2020 and POLARx FIT now. And more recently, FARAPULSE, I was really leading the launch of FARAPULSE in Europe straight after the acquisition. And I guess we'll hear probably a few more times the name of FARAPULSE during the day. But for now, let's focus about -- and of course, with me Dr. Brad Sutton, Dr. Brad Sutton is an electrophysiologist by background. Practicing electrophysiology as well and now Chief Medical Officer for the AF solution franchise, so WATCHMAN and EP. Okay. Let's talk about WATCHMAN. I truly believe WATCHMAN is an amazing category leadership story for Boston Scientific. For the last several years, we have been leading the way in this high potential LAAC grow market. We continue to see strong double-digit growth accretive to BSC, and I'm happy to report today, we are actually opening today that we surpassed 350,000 patients that have been treated with the WATCHMAN therapy. So clearly, the team has built a foundation to be in a great position in the marketplace today. Still, we keep raising the bar. And we remain absolutely committed to focus and grow the LAAC market to leading innovation and expand globally. Now in this slide, you can see really how do we see the WATCHMAN LAAC market today and moving forward. And this is why we believe this market may quadruple from 2023 to 2030. On your left, you see the evolution of the WATCHMAN patients in the United States. And as you can see, we have been growing the therapy more and more every single month. The good news is in the middle. The good news is that we are today only 10% of the penetration of the U.S. patients according current indication and current reimbursement. And this is really what makes us confident that we can continue to grow significantly in this market in the more short term. Thinking about more the long-term, well, today, there are 38 million people globally that are suffering for atrial fibrillation. We believe this number will get up to 60 million people by 2050. So clearly, the number will be increasing. And we have a wonderful clinical trial pipeline that Brad will talk about, that if positive, make us confident that we can really expand the indications, U.S. and as well as internationally, big time, and bring this market over the $6 billion in 2030. So now going back to more the short term, Also, I'd like to show you why we feel extremely confident that we can continue to drive penetration in the U.S. market, as I said, with existing indication existing reimbursement. And this is really thanks to the totality of our coordinated market development effort that really helps lead to a better patient experience. First, starting with our patient awareness, our direct-to-patient campaign which really is meant to create awareness and education in the general public in the target population. And we actually just launched a new commercial ad that I will show you later in the presentation. Then, of course, going to the referral base, and I think we are uniquely positioned for the referral base with our therapy awareness representative field force, our [ tariff in ] force. This is really what the field force that creates the link between the patients and the implants and also make sure that referrals remain engaged in the patient journey after the WATCHMAN implant. And lastly, of course, the bottom part, which is really our portfolio development. We continue to invest. I'll show in the next slide, our pipeline. But what is more important also -- is equally important, let's say, it's our capacity and workflow digital solutions. That really meant to really help the centers to be more efficient and to be -- also to expand the number of patients treated. And last but not least, our EDUCARE programs they really look at case efficiency and more -- and also implant success. Implant success, which is absolutely critical. And today, we have demonstrated is over 98%. And then we'll talk in a second about new patients with our indication expansion trials, of course, CHAMPION AF and OPTION and last but not least, what we are launching today with the launch of FLX Pro that LAAOS-4 and monotherapy. Brad will cover that in a second. And talking about leading in innovation, then a few seconds about our portfolio. We remain committed to develop our portfolio and move the bar -- continue to move the bar higher. We continue to invest heavily on a differentiated portfolio. Here is a snapshot of our innovation. Today, of course, beautiful story with WATCHMAN FLX and our VersaCross radio frequency transseptal solution, which really facilitate the access and is used in over 55% of the WATCHMAN implants and this number continues to grow. Of course, FLX Pro, we cannot be more excited by being here today and just have received the FLX Pro approval from FDA a few days ago. And Brad will comment in a second, our next steps for the FLX Pro. I just want to close on this slide saying there is more to come next year, which is the Watchman TruSteer. It's a steerable shift that has been specifically designed for WATCHMAN implants. Again, continuing to develop our portfolio and make the patient experience seamless. With that in mind, I'll leave to Brad to comment about FLX Pro.

Thanks, Angelo. Good morning, everybody. The WATCHMAN FLX Pro recently FDA approved and what I can tell you about this is, it brings some meaningful sort of iterative changes to the therapy. And I think it potentially unlocks the opportunity to simplify the post-implant drug regimen. So WATCHMAN FLX is still the fundamental framework for this device. It's the same night -- and all structure. It's the same performance that you know, and we've seen phenomenal results with WATCHMAN FLX. What's new about this device? We've got 3 radiopaque markers on the shoulder of the device that aid in fluoroscopic guidance and placement at the [indiscernible] of the appendage, a new 40-millimeter device size. So the sizing matrix here has expanded and this is particularly important in our Asian markets, where interestingly, left atrial appendages tend to be larger on average. What's most differentiated though is the hemocoating. So this is a proprietary coating, a durable fluoropolymer coating which in preclinical studies shows a couple of really meaningful things. Number 1, it seems to heal faster and more completely and more consistently. Number 2, there's hints that it's antithrombotic and anti-inflammatory. And so we plan to study this in a post-market study, actually, I just got an e-mail 2 minutes ago that our first clinical trial site in the U.S. is authorized to enroll in a trial we call [ HEALLA ], a very large post-market study to look at this in detail. Next, you heard Joe earlier say we're not resting on our laurels. That's certainly true in the product pipeline that Angelo sort of outlined. It's also true in the smart bets we plan to make in the clinical science. And so looking on the left here, the story is really showing you the integral role that clinical trials play in the market growth overall. The OPTION trial, which is a randomized trial of WATCHMAN FLX implantation versus OAC standard of care in post-atrial fibrillation patients set to read out in 2025. We're very excited about that. And then the CHAMPION AF trial, which I think at the time, was a visionary trial to launch enroll very, very quickly in follow-up phase now, 3-year data set to be reported out in 2026. This positions WATCHMAN FLX and FLX Pro down the road as a first-line alternative to anticoagulation for stroke prevention. And I think if these trials read out the way we expect them to absolutely practice changing. As we look to the future, we've got LAAOS-4, which I'll go into some detail on in just a moment. This is looking at stroke reduction in very high-risk patients and the idea of concomitant therapy with both anticoagulation and appendage closure and then a monotherapy trial, which leverages the FLX Pro value proposition. So maybe I'll start just to dive deeper on the monotherapy trial. So this is looking at FLX Pro again, the opportunity to unlock a less intensive post-implant drug regimen. Why is that important? Because there's still this unmet clinical need of bleeding that occurs when you're on those medications immediately after implantation, whether it's anticoagulation and aspirin or DAPT, both of which are on label, you see the DAPT is the control arm in this 3-arm study that we have scoped and then the study arms would be single antiplatelet therapy or low-dose OAC. In LAAOS-4, which is a collaborative project that we're running with Population Health Research Institute in Canada, recall that's the group that in LAAOS-3 showed a 33% relative risk reduction in stroke in patients undergoing open surgery, looking at concomitant appendage closure and anticoagulation ongoing. This is recapitulating that high-risk patients and folks that are not surgical candidates or not undergoing open surgery, but in a randomized fashion, looking at concomitant OAC and WATCHMAN versus OAC alone, powered for superiority for stroke reduction. And with that, I'll turn it over to Angelo to talk about our global markets.

Thank you, Brad. So of course, WATCHMAN, as I said, is an amazing category leadership example in the United States. I mean, coming from the EMEA region, I really think there is plenty of opportunities also for geographical expansion in the future. And our global expansion is looking at some key target markets, Europe, Middle East, Africa, Japan and China. And as Brad explained, if the results of OPTION and CHAMPION AF are positive, we estimate a significant and exponential increase of candidates in the international market. We estimate this number to be around 11 million patients in the future. And so as you can see, there will be a bit of more time to get the results of these trials, but of course, we clearly see global expansion as 1 of the pillar of the WATCHMAN strategy. Okay. So I mentioned the TV campaign commercial. We are truly excited by our direct-to-patient campaign. We launched in August and really builds on the success and the learnings of our previous campaigns and further celebrates the growing number of patients who can live their life on their own terms, thanks to the WATCHMAN therapy. Now the message is clear is onetime for a lifetime. And the campaign really highlights the joy of living a life free of blood thinners and the worry that comes with them, while also reducing stroke risk. It includes this time, a diverse representation to really allow more [indiscernible] to see themselves as WATCHMAN candidates. Let's play the video, please. [Presentation]

So hope you have seen it. Well, I came here just in Boston, the other day, opened the television, and I saw the ad. Now Mike told me as well that if you are seeing the ad, probably you are around the 65 years old because that's the timing that we are targeting. So if you have not seen it, no worry, it means you are still younger. Okay. So with that in mind, let me close here. I want just to reiterate the WATCHMAN team's incredible winning performance. We are really in a leadership position, and we have an incredible product. But of course, our main focus is always on the next big thing. It is our goal to continue to innovate and penetrate the market more and more, and we are on the path to really taking our innovation portfolio to the next level. With that, I want to thank you very much for your time, and I'm truly excited to introduce our President, ICTx, Lance Bates has an amazing story about triple A. Thank you.

Thanks. Hi, everyone. I'm Lance Bates and I lead our Interventional Cardiology businesses. And I start with the company -- going on my ninth year this year. I started as the VP of Marketing for Interventional Cardiology. And that's one of the key reasons why today is so exciting because I'm sort of reaping what I sowed or living with the cooking that we put in place years ago as a team in terms of -- if you think about 9 years ago, that was the heyday of drug-eluting stents. The heyday of drug-eluting stents and the growth and the pricing. And fortunately, our team put together an amazing plan that has been executed to diversify the portfolio and make the right investments and bets that we're going to share today. But before we get into that, I'm really proud and excited to introduce to you Dr. Janarthanan Sathananthan as our new Chief Medical Officer for Interventional Cardiology. He's got an amazing background practice at some of the world's leading institutions, including Monash with our own Ian Meredith years ago, most recently practiced for several years at Vancouver General and St. Pauls in Vancouver with some of the leading thought leaders such as Dr. John Wood, who's been one of the fathers of TAVR as an example. Dr. Sathananthan is also published and been a part of over 160 clinical papers and trials and well published and well known in the world and most recently as well as an adviser for us, he's been working with our engineering teams with many of our developments. And today, some of the features that you're going to see on ACURATE, he's personally been involved with. So we couldn't be more excited to have Dr. Sathananthan join the team.

Yes. Thanks so much, Lance. It's a tremendous honor to be joining Boston and really this fantastic team that's with the company. It's great to meet you all for the first time. Please call me Janar unless you like tongue twisters, you're welcome to try and pronounce my name. But I look forward to starting this role and getting going.

Excellent. All right. We're going to dive right in and give you an overview. And first, kind of review what interventional cardiology is. It's a set of businesses to surround the interventional cardiologists. So it's our core coronary therapies business, which we're very proud of. It's #1 market share leadership for us today, and we're going to share with you how we're going to continue to accelerate our leadership position. The second business is structural heart, so that would be TAVR, mitral, tricuspid and associated technologies. And as Joe alluded to, our third business is our interventional heart failure business, which we are incubating rapidly as we move forward. So we're really proud about where we are today as well as being the most global business within Boston Scientific. 70% of our revenue in the coronary therapies business comes from outside the U.S. And a key part of our learnings interaction with June and her team and how we build that infrastructure around the world, whether it's China, Latin America, other parts of Europe and India is really a platform that we can also launch the other Boston Scientific businesses. So I'm going to go a little deeper into the markets that we serve. We are in big markets totaling about $15 billion, growing about 7% through 2026. And there's 4 key areas that we can separate out the $25 billion. The first is drug-eluting therapies, which is drug-eluting stents and drug-coated balloon. Overall market is growing about 6%, but the key thing there is if you dissect that, the drug-coated balloon part of that market is estimated to grow at 20%. And that's where we're focusing our investments that I'll share with you later. Complex PCI. This is the toolkit that we are known to have the broadest toolkit in the industry, and that is wires, micro catheters, balloons, cutting devices that can help treat the complex pathology that exists in these PCI patients. 9% growth, which is interesting, but the calcium treatment segment of that market is growing 15%. And you're going to hear more about that's where we're placing our investments in the calcium segment of that market. PCI Guidance includes 2 main components, physiology. Physiology is where you go into the vessel and you see if that lesion or that blockage is actually creating a flow dynamic and they got the IVUS or the imaging side of guidance. Overall, 9% growth, but the IVUS, the imaging segment of that market is growing over 15%. And again, that's where we're placing our bets and putting our chips on the table. If you talk about TAVR, we all know as a market TAVR is about a low double-digit growth segment. And part of that market for us is that we are one of the leaders in the accessories part of that business. So an example would be the Guidewire, SAFARI Guidewire, almost 1 out of every 2 guidewires, whether it's our valve or not is SAFARI, our iSLEEVE sheath is known as one of the best sheaths to minimize vascular complications. And we also have the world's, at least in the U.S., the first approved cerebral embolic protection device. So we are surrounding the procedure, and those devices are growing actually higher than low double digit. And that's where we're focusing our bets. So I'm going to go a little bit deeper into the coronary therapies portfolio and talk about what we believe our philosophy is for the treatment paradigm. Now part of this is no other company -- no other company has bets and products commercialized in all 3 of these categories. No other company. And that's why we continue to be the leader in the coronary therapy space. And this paradigm is see, prepare then treat. And the analogy is you have to see what's inside the vessel before you actually treat the vessel. Be kind of like driving your car at night without your lights on. And if a physician just relies on the angiographic 2D, black and white image alone, the outcomes are not as good as if they use IVUS imaging pre and post their procedure. So it's really important that's all we've placed big bets with our AVVIGO system as well as our physiology systems. Preparing. So once the physician has seen what's inside the vessel, it's important to prepare the vessel. So treat the calcium, whether it's a lipid or it's interstitial calcium or whether it's a calcium nodule, treat it with the right device, which we brought us portfolio with our WOLVERINE cutting balloon, which cracks the calcium as well as our Rotablator atherectomy system and our new rotadrive wire system to get more distillates in thesen vessels. The treatment, we all are well aware of drug-eluting stents. We continue to be the #1 market share leader in drug-eluting stents, primarily led by our XD portfolio with SYNERGY. We have a 48-millimeter. We have the MEGATRON, which is designed for large vessels, [indiscernible] and purpose-built for those complex anatomies. And I'm going to go into a lot more detail about our drug-coated balloon portfolio with AGENT here in a minute. So the broadest toolkit to treat the most complex pathologies in the coronary disease space. So I'm going to go a little deeper into what we call 2 of the As of our triple A strategy, and that is AVVIGO and AGENT. So AVVIGO is our IVUS imaging system built completely new from the ground up all new hardware, all new software, completely built on AI and machine learning. And an example of that is today, when a physician does imaging, such as IVUS, they typically have to manually trace, measurements and lumen gain and how they want to put the stent. Based on AI and machine learning, we can now do this in real time. So when the physician pulls the catheter back, real time on their screen, they're going to get all their measurements. They're going to know exactly where to place the stent, they're going to see what their lumen gains are, and they can also do their post-procedure follow-up. Hugely powerful because sometimes a physician, no offense Janar, might say, I don't want to use either because it's going to take a few more minutes. And we're taking away that excuse. You should do the right clinical thing for your patient and IVUS and AVVIGO are going to allow that to happen. Super excited as well to talk about the second A, which is AGENT. And so AGENT is not just any old drug-coated balloon. There's other drug-coated balloons on the market. And typically, what they do is they take the balloon, dip it in a drug and say it's drug coated. That's not us. That's first generation. We are the latest generation technology, and the reason I say this is putting a drug on a balloon is complicated, very complicated. Otherwise, it dissolves as it's being delivered, you don't deliver the right amount of drug to the lesion. We developed a patented proprietary excipient that allows us to adhere the right amount of paclitaxel to the drug, to the balloon, then delivers the right amount to the lesion after it's been delivered through the body. Super important because we have the right dose amount and the right efficacy, and it is very unique to Boston Scientific. And the second key point about AGENT is that it's built on the EMERGE balloon platform, which is the world's leading balloon. This is a same balloon platform that we deliver SYNERGY on and some of our other drug-eluting stents. Believe it or not, 1 out of every 2 balloons in the world is an EMERGE balloon. So when you combine our excipient with paclitaxel and our balloon technology, we're going to have the world's best drug-coated balloon for the coronaries. So what's coming to the U.S. is the fact that we completed the IDE and saved the date October 25 at TCT will be the late-breaking trial that we will review the results of the trial. That trial was designed for instant restenosis. So if you get a stent, sometimes years later, it comes back, clogged and you have to treat it. Today, typically, you treat it with another stent. It's like putting a donut in a donut, not a good thing. So what we're trying to prove is that if you put a drug-coated balloon in there, treat it, it's a better outcome for the patient. That's the results that will be shared. And 10% -- 10% of the PCI market is in-stent restenosis. And that's what we're going after first with our first indication. That could be a $500 million market. The next indications are small vessel rather than putting a stent in a small vessel treated with drug-coated balloon, the acute coronary syndrome patient, if this is a person in the mid-50s, that's had a onetime event, possibly using a drug-coated balloon might be a better therapy. Then we also have bifurcations and other areas that we're exploring because that could add another 20% treatable patient population to the market. So a huge opportunity for us, and we will be the first in the U.S. with a clinically proven product as long as the trial results are positive. And the other quote on the other side of the page about IVUS going back to that for a second, because of the success and the clinical outcomes, the ACC actually recently made this statement only 1 technology can be employed IVUS, especially HD IVUS, which is us, is the more flexible option and can be utilized in almost all clinical scenarios. Powerful statement that is going to again drive adoption and market growth. I'm going to switch now to the third A, which is ACURATE. And this is our TAVR platform. And due to a quick review, the first generation valve that we had for ACURATE was ACURATE. Then we launched Neo in Europe. And that's what some of the legacy data that you've heard about with Scope and Scope 2. That was on Neo. Neo2 is what's now launched in Europe and other markets in the world. And Neo2 is what was used primarily in the U.S. IDE trial that will know the results of later in the near future. We are now introducing Prime. So the fourth-generation platform for the ACURATE system. And part of the reason this is so exciting and Janar is going to walk through what some of those enhancements are is that when we launch in the 3 biggest markets in the world, the U.S., the EU and Japan. We're going to have all risk indications, and we're going to have all sizes. So for example, today in Europe, we do not have the XL size. So we're limited into the patient population we can treat. So it's really important to know that we're going to have all sizes, all risk indications, and it's going to be on the Prime platform. Today, our success in Europe, which we're getting about 20% market share in the accounts that were active and we've launched is on Neo2 and it's without the large size. So there are the reasons to believe that we can be extremely successful when we enter the TAVR market. And you can see the dates by the back half of next year for the U.S. and then EU early '25 with the prime system in Japan as well 2025. So without further ado, I'm going to turn it over to Janar to walk through even more details of our clinical data and the new Prime platform.

Yes. Thanks so much, Lance. So what I'm going to take you through now is just our experience to date with the ACURATE platform. But what I'm more excited to share with you all today is what we have planned for the future. So if I draw your attention to the middle of the slide, the first point to make is that the ACURATE platform is an established platform. There have been more than 60,000 clinical implants with this platform and more than 9,000 patients enrolled in various clinical trials. Physicians around the world have been impressed with the device's ease of use, its reliability and its performance. And that positive physician experience has also been backed up with great clinical data, as you can see on the screen, with excellent hemodynamics, low gradients, low permanent pacemaker implantation and a very low rate of significant paravalvular leak. The design of the valve is also incredibly unique and makes it one of the best valves for coronary access after TAVR and also provides options for repeatability as well. On the right-hand side of the screen, as Lance alluded to, I'm excited to tell you that we've completed enrollment of our large ACURATE IDE trial with more than 1,500 patients that includes a Prime Excel nested Registry, and we continue to enroll in our continued access study and to reinforce that point that this includes all patients of all risk categories. It will add to our building evidence with the ACURATE platform and will also help aid with future indication expansion. So like all good interventional cardiologists, I like toys, and I'm really excited to show you our next-generation ACURATE Prime platform, which builds on the excellent performance characteristics of the Neo2 platform with some further enhancements, some of which are detailed on this slide here. There's been an improvement in the frame, which will help aid in more complex cases and improve performance. There's a new size that expands the treatment range and provides the spell for more patients than it previously was able to. The delivery system, which was already very simple to use has been made even more ergonomic for more stable and reliable deployments of the valve and all our sizes are compatible through our existing iSLEEVE sheath, which has always had great feedback. So we really feel that this is a valve platform that is super annular and really provides no compromise. And earlier this year, at the large TVT meeting, there were 2 live cases performed with this platform, and the feedback was very impressive with regards to its ease of use and its unique design features. I had the pleasure of performing 1 of these live cases, and I'll show you a brief highlight of that case on the next slide, if we can just play that video. So the first thing to show you here is that the valve has a unique deployment with a top-down deployment, and you can see -- I can tell you from experience, and experience of other clinicians that it is a very stable and stress-free deployment. And very shortly, you'll see just with the turn of my right hand, you will see that the valve will be deployed in a matter of minutes, and that's just going to come up very shortly now. And so just like that, this patient has had aortic stenosis and now has a totally functioning valve in a matter of minutes. Now you'll see just some of the unique features of this valve platform that sets it up for future considerations like coronary access. In a matter of minutes, after we put this valve in, we were easily able to cannulate the coronary arteries. And so it just shows you the strength of this platform. And so we're really excited to bring this therapy to patients and to help improve outcomes for them.

Thank you. All right. Next, I'm going to quickly walk through what we're doing in the interventional heart failure space as well, there are some areas. We're making some major bets, both internally and with our VC portfolio and other partnerships. These are going to unlock another $25 billion of market opportunity to go with the $15 billion that we're already playing in. I'm going to quickly go through this because I could spend 4 hours on each category. I don't think any of you want that today. But on the left, internally developed our left ventricular circulatory support device. It's 1 platform in terms of a console and access as well as the motor that is used for high-risk PCI and cardiogenic shock. We also have VC bet in renal denervation. In mitral and tricuspid spaces, we have 3 bets, 1 in mitral repair. The others are in tricuspid repair and replace heart failure. This is the idea of improving the effectiveness when diuretics are not working anymore. This is a device that goes down near the renal arteries to help improve flow and function. With a bet in the shunt space that many of you know about, we've started the clinical trial there. flow modulation internally developed for right side heart failure, IVL, the lithotripsy space, we developed some [indiscernible] internally that we spun out and are now working closely with in our VC portfolio. Then some tech accelerator ideas, just to give you a flavor of this, this would be like in the valve technology, leaflet technology space, so dry tissue and polymer. So the point is we are extremely active. These are all real, the real bets either internally or VC bets or partnerships that we're incubating to drive the future growth in the next 5 to 10 years after the LRP. So as I bring this home we're obviously super proud about our track record and the fact that in coronary therapies, we are the #1 leader, and we're going to continue to grow our leadership position. In structural heart, we are really, really looking forward to launching ACURATE. We're humble. We're very humble, but we also got a bit of swagger, don't we, Janar?. We got some swagger with ACURATE. And then in terms of interventional heart failure in our future, what we're doing there is so much to be excited and proud about. So in closing, I've said, I'm really proud about where we are today. but I'm even more excited about our future and where we're taking this business to the next level. Thank you. And with that, it's my pleasure to introduce Nick Spadea-Anello, the President of our Electrophysiology business and bring back Dr. Brad Sutton.

Okay. I think I am the last presentation with Dr. Sutton. For those of you that I don't know, Nick Spadea-Anello, very excited to be here. A little bit about my background, 30 years of the medtech space, 24 years with Boston Scientific. In those 24 years, started out launching cardiac resynchronization therapy, then transitioned into helping stand up the WATCHMAN business with Jim Cassidy. And most recently, both Mike and Joe asked me to transform the field of electrophysiology and it is truly an exciting opportunity. Today, Dr. Brad Sutton and I will highlight our vision and all of the hard work that many people -- talented people here at Boston Scientific are doing to transform the field of electrophysiology. And this very, very important work will allow patients to have access to innovative therapies, simplify procedures for operators throughout the world and what we believe will make things incredibly more efficient for hospital systems. We're at such an exciting opportunity in EP as we sit on the precipice of huge growth. And this is a big, big opportunity here at Boston Scientific to introduce what we believe is transformative technology, as Joe had mentioned, that can disrupt the entire field of cardiac ablation. There are going to be several things we're going to ask you to note as key points in this presentation. First, we feel very confident that we have a very comprehensive EP portfolio that will provide patients operators and hospital systems with a range of improved solutions, we feel are going to best fit their needs, drive more desired outcomes and again, drive the efficiency that hospitals are in dire need of. Second, our EP portfolio has the strength to be able to grow well beyond the market. With a specific focus in the AF segment of the market. And then lastly, we are solidifying ourselves as long-term global PFA leaders with FARAPULSE. We treated over 25,000 patients worldwide, and our development clinical and commercial strategy will allow us to treat many more patients in the future. We do see PFA specifically with FARAPULSE being the new standard of care for the future of AF ablation, given the reliability and reproducibility of the procedure while demonstrating safety and efficacy with entirely new levels of productivity and efficiency. So let's turn to how we intend on transforming this market and take a closer look at this very, very attractive $8 billion market that will continue to grow. There are over 1.4 million overall cardiac ablations conducted annually. And about 60-plus percent of these are AF related, which happens to be the largest, the most common and the fastest-growing arrhythmia. The middle part of this slide highlights those 850,000 AF ablations that are conducted both between the paroxysmal and the persistent patient population, which brings attention to the 38 million AF patients that exist worldwide that Angelo mentioned earlier, we believe that this represents a significant patient opportunity where we can treat them specifically in this persistent AF patient population. And Dr. Sutton will address that are in terms of how we plan on doing that with our clinical evidence. To the very right-hand side of this slide, we have segmented the current energy sources when operators choose to conduct AF ablation, which today is largely focused on the RF ablation energy source. But we see a major shift over the course of the next several years over the pulsed field ablation. I'd like to now focus our time on the commitment we've made the last several years to build what is the most comprehensive EP portfolio in the industry. This slide highlights various options for physicians and hospital systems to select what we feel is the best solution for their patients. We have made several key investments in our ablation therapy offering and feel that there are diverse growth opportunities with varying interest in RF, cryo and PFA over the next several years. We are very favorably positioned as physicians elect to make different choices by having all of these energy modalities and prepared for that change. In Access Solutions, we made key acquisitions -- a key acquisition, I should say, in Baylis that enables us to have global leadership in the transseptal crossing space. We are planning on advancing our position and continuing to grow with Access by introducing our VersaCross Connect product series. As a matter of fact, today, we treated the first patient with the POLAR VersaCross Connect series in Chicago at Northwestern with Dr. Brad Knight. And we're excited because we believe this series will continue to grow. You heard from Angelo about the usage of VersaCross with WATCHMAN, 80% of the WATCHMAN procedures use Baylis or VersaCross with their technology or I shouldn't say all of Baylis, 55% specifically with VersaCross so we see a big opportunity to continue to grow with our Access Solutions business. Let me focus a little bit on POLAR, the cryoablation efforts that we have. We see both growth opportunity and customer engagement opportunity over the next several years even with the strong excitement of pulsed field ablation. We have realized market share and revenue gains in both EMEA and Japan and expect to drive even further share growth with the introduction now of the POLAR FIT balloon system, which was recently launched in both of those markets. The POLAR FIT balloon system is our 2 balloons in 1 catheter, a 28-millimeter and a 31-millimeter balloon that we believe is able to treat many more anatomies. The 31-millimeter balloon is the only balloon in the market, and we think that this makes a big difference. And for those who are using cryo today, when they use our POLARx system, specifically with the POLAR FIT balloon system, the 31 millimeter, they see the big advantages that it offers, and it should because the other technology is nearly a decade old. We also see continued revenue growth in the U.S. market now that we have U.S. FDA approval. And then 1 final point on POLAR and our cryo business is around the FROZEN AF IDE trial, we saw 79.9% freedom of atrial arrhythmias in the IDE trial 12 months and an amazing 88% reduction in atrial arrhythmias in the 31-millimeter at 6 months extension arm of the research trial. I now want to shift our focus on how we see the ablation market evolving over the long-range plan. We see a dramatic shift to pulsed field ablation with FARAPULSE over the next several years given the safety, the simplicity, the efficiency and efficacy associated with this newly tested source. This slide highlights the different operator treatment approaches to AF ablations. We also want to share how and why we believe pulsed field ablation will be the primary energy source for AF ablation in the next 2 to 4 years and beyond. First, operators differ in their approach when ablating AF patients. And Dr. Sutton can comment more on this in a little bit. Some conduct PVI alone while others believe in performing other anatomical lesion sets with their pulmonary vein isolation ablation, which we classify as PVI plus. The PVI and PVI plus procedures are evenly distributed and both approaches are projected to grow double digits through this time frame. We estimate the energy source of choice shifting considerably 60% to 80% pulsed field ablation by 2028, given the safety profile, the need for greater efficiency, the sedation benefits specifically with Farapulse and the operator peace of mind and what we see very early on high patient interest. We also plan to initiate a frontline treatment trial with persistent AF patients called in the first half of 2024 and see this driving adoption in this underpenetrated persistent patient population. Now let us move to what is one of the most important parts of this presentation, and that's on our cadence of product development and clinical evidence, which we feel will drive continued opportunities around our PFA leadership with Farapulse. Our FARAWAVE catheter has been designed as a very simple PFA tool for PVI ablations. The unique and proprietary pentaspline design with dual flower and basket configuration allows operators to perform a very safe, reliable, predictable and efficient PVI ablation. Clinical evidence has shown that the design of FARAWAVE avoids three major complications: phrenic nerve palsy, pulmonary vein stenosis and atrioesophageal fistulas. And these complications come with severe consequences. We believe we can set the new standard with Farapulse as it relates to safety. In late 2024, we plan on introducing the next-generation FARAWAVE catheter with navigation capabilities in the U.S. market. The new FARAWAVE catheter will take the same clinically validated workflow and provide integrated mapping capabilities on our HD mapping system with our new FARAWAVE mapping software. We're also planning to expand our PSA portfolio with Farapoint Plus. A point-to-point focal PFA catheter for operators that wish to address PVI plus lesions such as CTI lines. Farapoint Plus will also have NAV-enabled capabilities upon approval, which is expected in 2025. Farapoint Plus is part of the second phase of the ADVANTAGE trial, which will begin enrollment in the next 2 weeks, and we expect to complete enrollment in Q1 of 2024. Our PFA product development strategy with Farapulse will be accompanied by our commitment and continued leadership in our clinical evidence. We just presented ADVENT at ESC for paroxysmal patients. The first and only PFA randomized clinical trial that was presented of its kind. We finished enrollment in ADVANTAGE several weeks ago, which is our indication expansion for persistent patients and studies the posterior heart wall workflow using FARAWAVE. The feedback we've received from physicians and those who are using it outside the U.S. is that the flower -- the unique flower form factor allows for a very simple and efficient posterior wall application within minutes. Again, we want to emphasize the importance of peace of mind of the operator by having a very safe, very simple, efficient, multipurpose catheter that has clinically proven waveforms. I'll mention once again in 2024, we plan on introducing the next landmark PFA trial Avant garde, which we expect this trial to unlock that market potential we talked about earlier, much further and expand indications to be able to treat many more patients. I want to now turn your attention to workflow, specifically in the area of imaging. Today, a physician can choose to use fluoroscopy, ICE or 3D mapping with Farapulse. Our advantage is providing our customers with choices that do not lock them into any one ecosystem. If customers want a simplified workflow without mapping, our system will provide that option, which is common practice in Europe and clinically proven. If customers prefer to map with competitive mapping systems, we will allow for that option as well. The operator experience will not be as optimal, but we do not want to limit the use of our proven Farawave catheter and generator for those that can't afford to commit to new mapping capital. If customers desire the absolute ultimate mapping and navigation experience with Farapulse to obtain precision and efficiency with what is a purpose-built catheter, we will offer that choice as well. We're excited because FARAWAVE NAV and FARAWAVE, the software, Farawave, I should say, with our HD mapping system will take this to a whole new level. It's the confidence that we hold in our catheter and our waveform along with our belief that it's highly important to provide hospitals as many options they desire to support their operator facility or most importantly, patients. At this time, what I'd like to do is take a moment to show a very short video featuring Dr. Jose Osorio, an electrophysiologist at HCA Florida, who is one of the pioneers of RF ablation workflow and efficiency and an experienced user of Farapulse trial work and an author in the New England Journal of Medicine Advent publication. You'll also hear in this video Dr. Boris Schmidt, an electrophysiologist at CCB in Frankfurt. Dr. Schmidt is a real-world user has been part of the research efforts as well and has seen the benefits of PFA and what it has brought his patients and his practice. Let us now roll the video, please. [Presentation] There's an explosion in the number of patients with atrial fibrillation. We're all seeing this, we're all sensing this. The data behind the outcomes of AF ablation therapy is ever better, and we continue to improve with better safety. And with the number of patients needing an ablation, now we have a need for better workflows and the ability to do these procedures safer, better and more efficiently. We should all be very aware that pulsed field ablation does not equal pulsed field deflation. Every single device has to be evaluated on its own for safety and efficacy. When we started using the FARAWAVE catheter for PFA ablation, we have the idea of adapting to the versatility of the catheter, to the simplicity of the catheter, creating a very streamlined, very straightforward procedure. Safety is the most important factor. The whole procedure is simplified, meaning that we don't use 3D mapping. We also used sedationally protocols using propofol to perform a pulmonary vein isolation procedure. And that, of course, adds to the simplicity of the whole approach. Even if I had exactly the same procedure times to what I currently have. I would still have interest in the technology. Looking at only procedure time is not my interest here. Our interest is the safety profile, not having to worry about atrioesophageal fistula, pulmonary venous stenosis and other complications. I think the patient experience not just because the procedure is shorter but because the inflammatory process, post-ablation is so minimized compared to [RAF], I think PFA will be a welcome to all. Based on my experience, during the clinical trial and then watching experienced physicians that have done hundreds of ablations with Farapulse in Europe. I think Farapulse will check all the boxes. It gives me everything I want to standardize the procedure and to make it ever more simplistic with good outcomes.

Good outcomes. And as it relates to outcomes, I'll hand things off to Dr. Brad Sutton, who's going to discuss our clinical evidence strategy.

Thanks, Nick. That video I've seen it a few times is inspirational every time I see it. When Dr. Stein and I trained, we were doing pulmonary vein isolations, it took us about 4 hours a case. We were excited when we could fit two cases in a single lab in 1 day. And it's amazing how far we've come in this field. I'm told that you all would have done your homework on this field and on this technology in particular. So I won't drain this slide. I'm sure have seen the ADVENT data. But I will say that we, with our head start commercially have, by far and away, the most evidence both in the real world and in this prospective randomized study, in particular, of any PFA system. And what ADVENT did is really set the bar. You probably saw last month, the New England Journal publication and simultaneous presentation of the data at ESC. We took 607 patients across 30 centers, 60-plus operators. Only one of whom had touched the system before. So this is as early as you can get in the learning curve or the operating curve in that clinical experience. This was a non-inferiority study design, randomized to thermal ablation that is cryo and RF as the standard of care. And what we showed is that we met all primary endpoints. The efficacy data for the PFA arm -- for Farapulse arm was 73.3%. This is at 12-month freedom from atrial fibrillation arrhythmia. Single procedure success that is no ablation allowed in the blanking period and off antiarrhythmic drugs, which is relatively unique study design and a relatively high bar in this field and something to keep in mind as you look at competitive data. I'll say that we met superiority for one of the secondary safety outcomes, which is pulmonary vein narrowing -- pulmonary vein stenosis, which was analyzed on pre and post chest imaging and quantify was driven largely by the RF group. And then, of course, noninferiority in the primary safety outcome with an overall serious adverse event rate of 2.1%. As we've seen in the commercial experience in Europe and Asia, the efficiency story remains really compelling with this technology. So here, ADVENT demonstrated a 42% reduction in average ablation time. And on average, more than 17 minutes reduction in procedure time overall compared to the world's best thermal operators with a technology in cryo and RF that they've been using over thousands of cases for over a decade. We did see [a mark] in January 2021, which has really allowed us to collect, I think, some meaningful real-world data. If you look at both the MANIFEST-PF registry and the EU-PORIA registry, both of which have been presented on podium and are now in print, we see overall really low rates of adverse events, less than 2% overall. There was one death in this entire cohort, and the efficiency story stands up in the real world, even again, with early operator experience. What we've seen pretty clearly is that the learning curve is less steep than it is with thermal ablation. These fluoroscopy times get lower as you get more experience. And really, it's an amazing story with over 25,000 patients treated, the consistency with which the procedure is done and the outcomes that are achieved. In my mind, it's a relative democratization of AFib ablation and that's particularly compelling when you talk about the more complex patients, the persistent AF patients in the PVI plus strategy. We seek to sort of be category leaders in atrial fibrillation, which is maybe a bold statement given our market position historically. But if you think about the story and the way we're wrapping around atrial fibrillation as a whole, that patient, that disease state, which is not static, but it moves on over time. Across cardiology, we have a diagnostics portfolio in LUX and Preventice. We have now treatment for reduction in all three ablation modalities. We get stroke prevention with WATCHMAN device. It's a really compelling way to partner with healthcare systems and healthcare providers to say Boston Scientific is a complete solution across AF care, focusing in on kind of expanding the eligible patient population. We talked about the process with patients in ADVENT. And Nick touched on the ADVANTAGE trial. This is a single-arm study that has a prescribed PVI posterior wall workflow. So what does that mean? We've long wondered if additional ablation in the poster wall of the left atrium adds to the efficacy in the persistent more disease left atrial states. Now in the radio frequency era, that's never borne out. Those of you who follow this field closely know that data has been underwhelming because we can't get durable isolation in the posterior wall with radio frequency. We're too concerned about the esophagus and the thermal damage risk with thermal ablation. We don't even monitor the temperature in the esophagus with this technology. And we believe with Farawave, not only do we get an efficient workflow, but a durable posterior wall isolation with a relatively tissue selective nature of PFA, no concern for esophageal damage. Also studying persistent patients but moving the strategy upstream is the [avant garde] trial. We look forward to that kicking off in the first half of 2024. This is frontline persistent patients. This is a randomized trial, randomizing to antiarrhythmic medications. And this study sort of takes advantage of the growing body of evidence that early ablation delays disease progression. We've seen this done in the paroxysmal space with first and often done with cryoballoon. This is, to my knowledge, the first real prospective randomized effort in frontline persistent AF, and we're excited to get that underway. Again, the proprietary flower design of this catheter, coupled with the waveform optimization that the team has developed over many years and the dosing strategy that's prescriptive in both pulmonary veins and the posterior wall, make this a particularly compelling workflow. I just reviewed a manuscript that's out of Europe, a very large cohort, not in print yet, but it will be soon of persistent AF ablation with this technology. On average, the posterior wall takes about an extra 10 minutes to ablate. With that, I'll turn it back over to Nick.

All right. Well, thanks, Brad. And we want to appreciate really all the work that I said earlier, our team is making to transform the field of cardiology. We can't do it without them. We're excited because our focus is really making things much better for patients, simpler for operators and driving that efficiency with hospital systems. And our goal is really make people live better, live longer and be a big part of this growth journey here at Boston Scientific. Thank you for your time.

Thanks, Nick. Thanks, Brad. Can I invite the rest of the cardiology team up to the stage and we'll start some Q&A. All right. We're going to go with Larry first over corner.

Larry Biegelsen, Wells Fargo. Just two for me, one on WATCHMAN, one on Farapulse. So WATCHMAN, I was really struck by the market size, $2.5 billion going to $6 billion from 2026, I think, to 2030. That's like a 25% CAGR even faster than we're seeing now I think. So what gives you the confidence in the option in champion AF trials being positive? What gives you the confidence in that? And then I had a follow-up on Farapulse.

Confidence in the outcomes of the trials?

Yes.

I think you're harking back to the price and [indiscernible] data, which was the European experience randomizing patients to OAC versus appendage closure, which was noninferior as you recall. I will say I've been with the WATCHMAN franchise since 2019. We debated that trial for years, frankly. And the confidence overall in the community has just gone up and up and up. I don't know if there's anybody who thinks that's a high-risk trial anymore.

All right. That's good to hear. And on Farapulse, I think we're all probably trying to figure out kind of what this could mean actually for your EP business. And just -- I apologize for the numbers, but the AFib ablation catheter market, $2 billion to $2.5 billion today, I want to confirm that your share is relatively low with that. You have a 16% CAGR for the AFib ablation market in the slide. So that gets you to, call it, $3.5 billion ablation catheter market in 2026. So if can you share is, call it, 25% of that, you had PFA at about 50%, are we -- is that the right way to think about what Farapulse could mean to your EP business, call it, over the next few years?

Yes. I think just maybe some comments on the modeling and then maybe we can follow up with Brad or Ken on the clinical science and what we just saw a few weeks ago. I mean we strongly believe, given, call it, the safety element of this and how it compares, as Brad had said, to traditional energy modalities. And the ease of use for operators, we see people making a transition rather quickly. The efficiency of it, being able to do, you're doing two or three ablations a day to be able to do 4 to 6, I mean, that's real. That's happening in Europe right now. And so I think the modeling is really going to be about us introducing it once we have FDA approval and our belief is that there's going to be strong and fast adoption. And our belief is that we are leading this. We intend on continuing to lead it. And we feel really good about just the advantage we have in this space and what it can do to patients, simplify operators to stress-free procedure and for hospital systems who are struggling with efficiency.

I'll add to that, Larry, too, I think that $5.5 billion AF ablation, you have to remember that there are a lot of ancillary things in every ablation case, mapping catheters, CS catheters, et cetera. So it's been pretty proven over the years that the person who controls or the company that controls the ablative source pulls through the majority of that. So I think your description of the $2.5 billion catheter market is probably the conservative because of -- it's pretty well proven. It's $5.5 billion when you talk about everything that's used during an AF ablation case.

And I just -- we're all piling on here. But I think -- I want to think about it in a couple of different ways because one thing to think about, right, is just taking share from the procedures that are currently being done, right, the move from thermal ablation to Farapulse PFA, again, driven by safety, by efficiency. I think the second thing to think about is just growing the market, right? And growing the market in paroxysmal AF because of the promise of greater safety. But also, I really want to highlight what Dr. Sutton said in terms of the promise of not just better safety but potentially better efficacy with persistent AF ablation, right? And then being able to do safely but also incredibly efficiently posterior wall ablation. And you heard -- I mean, literally just adding 10 minutes on to the procedure to do a full posterior wall ablation, right? And so I think that will drive a huge number of new referrals in for persistent AF and then the overall efficiency of the procedure will enable labs not just in the U.S. but worldwide be able to scale to meet the overwhelming demand there is just based on the huge prevalence of atrial fibrillation.

Great. Danielle?

Danielle Antalffy from UBS. Just two questions. First question was the -- on the interventional cardiology business and specifically the comment on calcium, the C prep and treat. So on the prep side of things, do you guys think you have everything you need in the portfolio when it comes to addressing calcification? And then I have one follow-up.

So the answer would be we have a toolkit today, and we talk about our WOLVERINE cutting balloon, atherectomy, crossing wires. And we also shared it with you, we do have an interest in IVL, which is why we've got a bet in the space. So our philosophy is have the right toolkit for the right anatomy and pathology, but it's all based on IVUS imaging first. Do IVUS to know what type of pathology you're dealing with and then use the right tool to address the problem. Not every hammer is for every nail.

Got it. Okay. And then just on ACURATE, the timing of this launch is going to be coming at an interesting point in the TAVR market sort of given where we are in the adoption curve here in the U.S. We'll see long-term TAVR data at TCT. Anything you guys can talk about as far as how you think of incremental growth in the TAVR market from here and where you see ACURATE having the most impact to who or where might you gain the most share?

I'm going to actually pass that to Janar and let you share maybe some perspectives on lifetime patient management, younger patients.

It's a great question. I think your first question was about the market. There's already quite a lot of imaging data that even though this a tremendous amount of TAVR procedures being done, the market is underpenetrated. And there's an underdiagnosis of this condition. So you talk about the rising tide rises all boats. It's the same thing that there's more and more patients being diagnosed with this condition. As it relates to ACURATE coming on to the market, I think the real strength is, hopefully, the video showed is that the platform is incredibly easy to use, and ease of use is going to be tremendously important for operators across the United States. You have more than 800 TAVR centers, the vast majority doing less than 100 cases a year. So having a platform that's safe and reliable is going to be number one priority. And then similar to what Lance described with our coronary portfolio of having all the tools, we also have all the tools with regards to the structural heart portfolio. So best wire, accessory devices. And so I think all of that will all play into the strengths of the ACURATE platform.

Joanne Wuensch here in the front?

Joanne Wuensch from Citi Bank. A couple of questions. If you're launching Farapulse year-end '24, how do you think about the ramp? I mean because we're all going to go back to our models and sort of want to think about level setting that expectation. And is there anything maybe I'm stretching here to learn from the WATCHMAN adoption in the United States that can be translated to the Farapulse launch?

Yes, a couple of things. So Joanne, great question. We're not going to give the specifics of how many accounts we launch and when we launch them, but we're going to go incredibly faster than what you saw with LAC with WATCHMAN. We just believe that the simplicity here, the need and the safety associated with this technology can really offer us the opportunity to move dramatically faster. And when you look at maybe some experiences or learning with WATCHMAN and Angelo can speak to the DTC, the direct-to-consumer, campaign, we have got hundreds of thousands of patients via the WATCHMAN commercial that connect with us in our system that we can educate on just what pulsed field ablation is, specifically Farapulse, and the unique advantages to have some level of consideration with their provider.

I think the other perspective, Joanne, is if you look at the spectrum, like between a WATCHMAN launch where we had like 11.5 clinical specialists, the day the product was approved, versus a CRM lead launch or a DES launch, those are the ends of the spectrum across our cardiology continuum. So if you look at the fact that -- and I said it in my opening, where we're going to have hundreds of people that are currently doing our POLARx launch, and we'll have even more than that when we get to mid-'24 and the comments on supply chain, which we feel very confident in. This looks -- if you say the spectrum is a DES launch or a lead launch or WATCHMAN, this is going to be way closer to that type of launch speed and cadence and quality than it is to something like WATCHMAN, which obviously, we had very little infrastructure coming out the door. And I think you have to pair that with all of the comments from Dr. Sutton and Dr. Stein on what we've learned in the 25,000 cases in terms of how quick can this be taught, how reproducible is it in close to 200 accounts across the globe now.

And then my second question has to do with you just got approval for POLARx, I think, I saw an RF catheter up there. Sort of if this becomes a standard of care -- excuse me for putting it this way, why are you bothering with an RF catheter and launching a cryo product?

Yes. Maybe I'll have either Ken or Brad comment just on where RF could potentially be used in the future because there is a place for it, and then I'll comment a little bit further about what the broader portfolio means.

Well, certainly, in the near term, RF isn't going anywhere. I mean there are -- what we're talking about here are atrial ablation use cases. There are certain SVTs and certainly, the work in the ventricle has yet to be validated in terms of PFA. That work is ongoing, but it's very early in that journey. What we've seen in Europe is that POLARx has grown in accounts where we've also launched PFA. And in fact, we've seen both grow simultaneously in a given hospital system. So we've been pleasantly surprised by that experience and [indiscernible] has caused us to be pretty optimistic about POLARx in the near term as well.

And the unique advantage we have is that people are going to live in different ends of the spectrum of accepting different energy modalities. And we're going to be there when they're ready for that change as I had mentioned in my presentation. As I look at, call it, the $1-plus billion cryo market that exists today, we've got a great second-generation product. And if people want to continue to use that, we will provide that to them if that's the thing that they need most, but we will easily transition them to any other energy modality, whether it's RF or, call it, PFA in the future. We think it's going to be PFA, but we're uniquely positioned to capitalize on some incredible growth, given the unique portfolio offering that we have versus others.

You can pass it right to [indiscernible] .

Peter Chickering, Deutsche Bank. But looking at the 60% market share for PFA as an energy source by 2028, can you talk about the pricing strategy for Farapulse in the U.S. and especially outside the U.S. in order to get to that market share?

Yes. We don't really elaborate on specific details about pricing. We're ranging that adoption. It could be more, it could be a little less, but we think it's going to be probably more by that time frame just because of the safety benefits. And what we're seeing early on in Europe and certain markets in Asia, I mean when people start using the catheter, they don't go back. And so as we launch fast and introduce this to accounts, and we intend on doing that rather quickly, we think people are going to be very comfortable with the safety profile and the efficiency. And it's going to go hard -- it's going to be hard to change.

So looking outside -- look at Europe, for example, at cryos where that is today in your relative market share sort of in there -- sort of does the pricing premium make a ton of sense relative to just picking up market share relative to prior pricing?

Yes. I mean, I'll comment. It's a product that brings meaningful value. It's just considerably more efficient. So we believe that this carries a premium that we're not going to disclose what that looks like at this point in time. I think it's important to note, given the investments and the opportunity it provides patients and operators and hospitals.

But -- and just to add and for the folks who don't want that, we also have what is clearly a superior product if you elect to use cryo instead. Nick mentioned some of the results, for instance, from our POLARx FIT study. And what I want to highlight on that study is every single patient in that study got at least one treatment with the 31-millimeter size something the competition can't match. And about half of the patients in that study use the ability to toggle between the 31 and the 28-millimeter size. And so again, I think what Nick said, right, our strategy here is, if you want the premium product, product that's, again, safer, more efficient, at least as effective, we've got the leading PSA platform with Farapulse. If you don't want that and you want to stick with cryo, we have the leading cryo platform out there. And we've got the only RF platform that gives you both force sensing and electrical coupling with direct sense.

Matt, over on the front.

Matt Taylor with Jefferies. So kind of a two-part question. One is on the WATCHMAN growth. Could you talk about the share that you think you could garner in 2030 or in the future what your advantages there? And then on PFA, who has the second-best PFA?

So let me just jump in. We're not going to answer the second question. And I think, again, based upon all the things we've been repeating, the nearly 200 accounts and 25,000 patients, we understand the unique benefits of our system, the waveform and the technique. But nobody answer that second question. Angelo, do you want to comment on...

What I could comment on the first on the WATCHMAN share, of course, I think we are pretty satisfied of where we are today, and we're really FLX has brought us. So I will not give specific numbers. But of course, like I said, we are winning with Flex and we believe that FLX Pro will bring incremental benefits to patients. And so of course, we are looking at that to continue to strengthen our catheter leadership.

I think the other thing, too, is if you look at my comments, we have this relentless pursuit of innovation. So you saw on Mike's slide that the team, as we put WATCHMAN FLX Pro across the goal line, rest assured because it was on Mike's slide, they're already working on the generation beyond FLX Pro. So that's just kind of our DNA of never arrive, continue to innovate. And if you have to outdate yourself, that's fine as well.

All right. That concludes our cardiology Q&A section. So we're going to bring up -- so thank you for your time. Thank you. All right. It's the moment you've all been waiting for the finance section. And I'd love to introduce Dan Brennan, CFO. Welcome.

Thanks, Lauren. Tough act to follow there with that crew.

Yes.

It's tough to follow. So I know I'm biased because I work for the company, but that was a pretty cool 4 hours. I think, hopefully, you got a sense of why we're so excited for the next 3 years of Boston Scientific. So I'll close us out here with an overview and summary of our overall financial goals as a company, and then we'll move to a final Q&A session. The slide should look familiar. We've used it in prior Investor Days, pretty simple, just shows what we think we can do over the next 3 years. Before I jump to that, I think it's important to go through '23. I think this has a chance to be a really exceptional year for the company and a great jumping-off point heading into '24 to '26. These are all our guidance -- our most recent guidance range. Guidance range is 10% to 11%, revenue growth off a 9% comp from last year. 80 basis points of adjusted operating margin expansion to 26.4%. $1.96 to $2 adjusted EPS, 15% to 17% growth and importantly, kind of grabbing that $2 milestone at the high end. And what I would say, better cash flow at $1.6 billion reported and $2.3 billion of adjusted. More to come on that in a minute. So now you move to '24 to '26, and I think these truly really are next-level goals. 8% to 10% organic revenue growth, a little bit higher than you normally used to seeing at this meeting, that 6% to 8% that's kind of become the moniker of BSC. 150 basis points of additional operating margin expansion over that 3-year period. So importantly, that would put us essentially at 28% and put that 30% long-term goal squarely in line. We've talked about that 30% goal for a long time. I believe it's achievable, have the plans in place, and that would put us at 28% at the end of 2026. So have that in line. Double-digit adjusted earnings per share growth. That's been part of our financial goals for many years. We've done a great job of achieving that over many years. And then this is new. So approaching 70% free cash flow conversion by 2026. 70% is kind of the industry benchmark at that 70% free cash flow conversion. I have a separate slide on that to go into more details. So with the summary out of the way, let me do three quick deep dives: One, margin expansion; two, cash flow; three, capital allocation. First, margin expansion. Look at the chart on the right, I'm proud of that as part of the team that's been able to accomplish that over time, taking it from what was 18% to what would be that 26.4% this year. I'm not going to stop there. It's part of the DNA of the company. Look to do another 150 basis points over the LRP. How are we going to do that? Importantly, I think all three key areas of the P&L can contribute, gross margin, SG&A and R&D. So let's do a little bit on each one. Gross margin. Headwinds and tailwinds, as you'd expect. First headwind. And it's -- if there is such a thing, it's a good headwind, this is a good headwind. We need to invest in our capacity due to the launches we have and the top line growing at that 8% to 10% organically, we need to invest in capacity. So as you look at the earlier part, particularly of the LRP, that's a headwind. It will get better as we get to that full scale launches of the U.S. for those technologies that you've heard about today. Similarly, FX. So with where rates are today and with the dollar having strengthened over the last 18 months, 24 months, in the earlier part of the LRP period, FX likely to be a headwind relative to gross margin. The tailwinds, those product launches. They will be accretive. And again, they'll be more accretive as we get into '25 and '26 as we hit the full scale of those U.S. launches and we work down that capacity. The culture at Boston Scientific of reducing cost, the VIP culture take cost out of the system every year alive and well. So that we're going to continue to do that every year. So the net of all that says, the gross margin this year should be approaching 71% is what we've said. I think over that LRP, we can drive gross margin improvements and it can contribute to 150 basis points. SG&A. SG&A is really all about driving leverage. When you have a P&L that's growing -- a top line that's growing about 8% to 10%, it provides tremendous leverage opportunities through SG&A. We're going to continue to work on centers of excellence, shared service centers, things of that sort of drive out inefficiencies in SG&A, and we'll also continue to invest in our commercial infrastructure to make sure that we drive the best outcomes in those new transformational technologies that we have. So we'll balance that as we always have, but believe SG&A can contribute to that 150 over time. R&D, pretty simple. We think we can leverage that to about 9% through the LRP. We're kind of in the mid-9s now through efficiencies, through better use of our global footprint. We actually want to do more R&D, and we'll have more dollars, obviously, even at [Audio Gap] the opportunity to contribute to that goal. Second, cash flow. And frankly, this is an area where we've lagged the peers, and you can see that here. So that pink box shows that kind of that 70% industry benchmark for Medtech, and we've been below that. So as Mike outlined, we plan to enhance our conversion, and we're going to get that to 70% by 2026. If you think CapEx and working capital, right, two key measures that go into cash flow, we're generally at and sometimes actually better than benchmark in our peer group for those that are outlined. It's really litigation and acquisition are the two places that impact us, and you can see that on the right side. Litigation has been a headwind. It's primarily mesh, and we're nearing the end of that. So that should improve as mesh diminishes, really in the short term and throughout the LRP. Acquisition were a bit different than many of our peers here. We fully integrate all of our acquisitions, again, which is a bit unique to us and that drives integration expenses. So that's a reconciling item that we have. And that's probably likely to continue. It's our number one capital allocation goal. So that's probably likely to continue. And then really unique to us, we have these tax buy-in payments where we take many of our acquisitions and we buy them into our highly advantaged tax structure, great decision. Great long-term decision to make. It's the right decision for the long term, but it does come with us with a near-term cash cost that impacts kind of today's cash flow. So those, to the extent that we stay acquisitive and that's our plan, those are likely to still be a part of it. Litigation gets better. But your takeaway is we should -- we will absolutely confident in our ability to improve our free cash flow generation and approach that 70% by 2026. Capital allocation. Our capital allocation has been clear and consistent for the last 10 years. It's actually been a big part of our success. The number one priority, high-quality, innovative, tuck-in M&A. We've done close to 40 deals over that time frame, $17 billion invested in our acquisitions. The next one down, that's new. So historically, we've repurchased shares opportunistically with excess cash -- twice in the last 8 years since 2014. This is a change that we like to our capital structure now where we'll actually have a goal of keeping our share count flat, effectively offsetting the cost of our employee share issuances each year. And so that would serve to keep our share count flat over the LRP. I think that's a good add to our capital structure, still leaves ample room, plenty of room for our -- to execute our M&A strategy. Balance sheet never been healthier in over a decade. Investment-grade ratings with all agencies, BBB+ or equivalent with all three. And as you take in the totality of our capital deployment, I think we're really proud of where it is. And M&A will remain the number one priority, but like the new addition relative to keeping the share count flat. So to close, you heard a talented, diverse group of Boston Scientific leaders today, detailed what they think they can do for the next 3 years. It starts with a commitment to growing the core and launching new and exciting technologies into high-growth adjacencies. We believe this, along with our relentless focus on achieving our financial goals, will put us on the doorstep of one of the most exciting chapters in the history of Boston Scientific, one where we seek to be the best performing large cap Medtech company, truly next level. Lauren?

Thank you so much, Dan. I'd like to invite Mike, Joe and Ken to the stage for final Q&A. Jayson?

Just maybe for Dan. I think it was mentioned earlier that revenue growth would be faster in '25 versus '24 due to the new product launches. Will operating margin follow a similar cadence there? Or is the 1 50 pretty linear through the LRP?

I think that's a TBD. So I think Mike outlined that and it's a math exercise, right, we'll have more of the launches and the momentum of the annualization in '25. But I'm very confident in the 1 50 over the 3-year time frame. Haven't really done our AOP yet for '24. We'll work through that. And we'll -- as we always do, we'll give you more details each year as we go through that. But I think it's -- I like the 1 50 puts us at that 28 over that 3-year time frame. That puts the 30 squarely in the sites as you look beyond that, and we'll let you know where it falls. But love the 1 50 over 3 years.

Okay. And just quickly following up on that. There was some commentary from different segments on operating margin expansion. Is there any one segment of the business that have -- that has obvious self-help dynamics? Or will segment margins pretty much kind of track with revenue growth?

I'd say nobody gets a day off. So there are some of our businesses that are at higher margins. So we ask less leverage of them, but everybody is expected to grow margins each year. And we look at it, and we -- and I think you'd be proud of this. We look at it and we make sure that we're investing in the areas for growth. We're investing in the places where we can drive that top line growth, but everybody is expected to grow their operating margin each year.

I do have one online from Robbie Marcus at JPMorgan. Thank you for a great presentation. Mike or Dan, moving the organic sales guidance to 8% to 10%, such a bar -- a very high bar. Clearly, PFA is a huge growth opportunity, but that's just one piece of the puzzle. How should we think about the contribution of PFA versus other key drivers?

We can't -- someone else asked earlier. We're not going to try to frame that at this point. So what we saw in the earlier slide is 6% to 8% has been our traditional, and we're having a strong year this year. And you saw the kind of 7% CAGR for many years on average, even in spite COVID. And then we have really the accumulation of these launches that you saw. And you saw great stories with MedSurg and Endo, Uro and Neuromod. You saw a great -- we just have a terrific launch cadence with agent with neo2, obviously with Farapulse, with IVUS. So I would say the biggest launches, the most impactful launches are in Joe's area. But all of our businesses have launches, and they have such a wide portfolio. But those four are the largest, most significant in terms of their influence on kind of where we are in that range or if we can get above that range. But everyone knows the size of the EP market. You heard 30 minutes today about the safety and the productivity. We're leading in clinical data. We're leading in real-world use. As Joe said a number of times, we'll have the supply chain to support the launch and the commercial scale to meet the moment at the same time. So that's obviously a big upside. That's quite frankly, difficult to quantify.

Thanks, Mike. Rich?

Rich Newitter, Truist Securities. Thanks for a great day of presentations. Two for me. So the first, just -- I appreciate you not, Dan, willing to comment on the cadence of margin. But you did kind of give some discrete detail on gross margin within kind of '24 with FX, and that won't be there for '25, '26. I'm just wondering, should we think ESE gross margin will increase over the long-range plan? Will it increase in 2024 with that kind of known headwind?

I think it's fair to say that there's probably more gross margin opportunity as you go through the LRP in terms of its ability to increase and help out on that 1 50. There's plenty of other areas in the P&L for SG&A and R&D to help out during that time frame. So what we've done for many years is manage all areas of the P&L and make sure that we deliver on the margin expansion commitments. And '24, '25 and '26 will be no different. If gross margin is a little bit less, we'll look for a little bit more out of SG&A and R&D, and we'll look to deliver margin expansion in each of the years.

Okay. Great. And if I could just follow up on the PFA line of questioning from before. So you guys are thinking about the category garnering 60% to 80% of the entire segment. What do you think is a reasonable share for you guys at that point in time when there's definitely going to be additional competitors in the market, not just the #2, but there's going to be multiple players out there? So as you think of where this market settles, do you think you're going to be a dominant shareholder all throughout even into kind of the end goal? Or how are you thinking about that? And what's in the plan?

Yes. So here's the way I would think about it. So it's really easy to know exactly who's going to be on the market with what in this long-range plan of 2026. So we love our position because we've seen other technologies and clinical studies. There's one company that just recently got a CE Mark. So our familiarity with all of the features and benefits and the physician feedback, that puts our confidence very high that we can be in a leadership position as we exit 2026 because they're all known knowns. We know, as you probably know, who's going to get approval when with what technology. And we've seen those used in clinical trials to support CE Mark or to try to get FDA approval. So we won't put a pinpoint estimate. But if you do your homework with users in Europe or people who've had exposure to all the clinical -- several clinical trials that have been done. Our confidence in the FARAWAVE workflow algorithm, the -- like Nick talked about, the ability to use this pretty much in any way you want. If you're an ICE heavy person, go do it. If you want to use someone else's mapping system, they do -- they did that in nearly every trial or every case in the ADVENT trial. So we -- because we know our system and we know that competitors' systems and offerings, we're real confident that we can be -- continue to be leaderships from today through the '26 LRP.

Great. Oh, Steve, we haven't gotten to you yet.

Steve Lichtman, Oppenheimer. Dan, a couple, I guess, for you. One, what role does pricing play in your gross margin outlook? Are you feeling better about pricing today now through a post-COVID than you did maybe in years past? And then I'll just ask a second on the tax rate. How are you thinking about that over the next few years, given moving parts there?

Sure. On pricing, yes, I do feel better about it than I did 3 or 4 years ago. It used to be kind of set your watch. We were down low single digits every year in terms of price. And through being able to thoughtfully look at new technologies and new enhancements and innovative launches, we have kind of an enlightened state of maybe getting that to where that's flat -- over time. And that's a big help to gross margin and operating margin and revenue. So that's where we are on pricing. With respect to the tax rate, with the laws that are in place now, I think our tax rate in '24 and '25 probably likely stays where it is. As you know, with TCJA that was put in place in 2016, there are some accelerators that come in, in '26. So I would say if everything stays the same as the way it is here, 200 to 300 basis points of upward pressure in '26, but still look to offset that and deliver the double-digit EPS each year over that 3-year period.

Great. Shagun?

Shagun Singh from RBC Capital. Mike, just a strategy question for you. You have a winning category leadership strategy here. Can you talk a little bit about the areas where you think you still need to win, how M&A plays in there? And then today, you guys talked about VC investments, internal initiatives really across the board. I'm just curious, what are you most excited about? And how do you think about robotics? I believe there was a slide which seemed to show a robotic prototype next to a lung indication. Just wondering if there's anything we can expect there?

Yes. So we have a lot to be excited about. You saw that most of that today. I think sometimes the Endo, Uro, Neuromod get underplayed because of all these exciting launches in cardio, but those are amazing businesses. And we continue to do tuck-in M&A, as we just saw with Neuromod just recently in Apollo, which we did 6 months ago or so with Endo. So what we are most excited about in LRP in terms of the needle movers are what you're hearing about today with and ACURATE, neo2 and Farapulse and IVUS in terms of the dollar impact. But across the portfolio, you see really category of leadership that's been developed over many years, and we'll continue to pour fuel on that. And most of our VC investments are in adjacencies within that category leadership profile. Like in PI, for example, we didn't -- weren't a player in interventional oncology before. We are a small player. Now we're really the market leader there. So we continue to find adjacencies that fit our call point, and we have leverage on the cost side. And our portfolio of 38 or 40 VC investments really span across the portfolio, but I would say they're more heavily weighted in Joe's businesses, Jeff Mirviss' and some in Endo and Uro. So it's really continuing to layer on faster growth markets in exciting areas on the VC portfolio. I don't know if you want to discuss robotics at all with...

Well, just a little bit. We get a lot of questions about robotics. And when we think about how robotics impact, particularly Endo or Uro, I'll give the Uro example, we are taking the approach of more of a deconstructed robotic solution, which is to say, how do we deliver the functionality that's really needed. And if you think about the StoneSmart solution that Megan articulated, it's utilizing artificial intelligence and connecting the laser to the scope to the irrigation system to provide a super high level of functionality that is monitoring every aspect of the procedure all at once. That is our approach to delivering something that gives the physician the kind of user interface that he or she is used to, but really elevates the performance of the equipment by tying them all together in a shared software kind of a platform. So I think there are different ways you can think about robotics, particularly in the med-surg space versus the traditional large robot kind of a concept that we have in our minds a lot of the time.

Yes. We don't see robotics disrupting at all the momentum we have in Endo and Uro. Maybe they can help augment some of the things that we do. That's also -- for us, it's always about choice making in these portfolios. So you won't see us do some big internal robotic program because it's choice making as to where we want to put our internal R&D and what trade-offs that we make. And I think we've gotten pretty good at doing that. And so we don't see robotics as a threat. Maybe it could augment some of the things that we do over time, but our portfolio of things we like to do organically won't include a big robot program.

All right. And our last question is going to come from Rick Wise.

This will be a four-part question. You'll keep talking, we'll see what you had to say. So I only had, I think, 27 questions on Farapulse [indiscernible]. For Dan, I guess, and Mike together, maybe talk, if you would, a little more broadly about the implications of reaching 70% free cash flow. So extraordinary, am I misremembering a decade ago, $200 million in free cash flow. It's sort of extraordinary to contemplate what that would mean. Is it just when looking at your capital allocation comments, Dan, is just more of the same in terms of tuck-in? Jayson, do we redefine the size of what tuck-in means or these -- some of the questions about do you add another piece to the whole portfolio and start building out another hub? How do we think about that?

I think we keep adding this more the same is working pretty good, and we keep adding pieces. And I'm really proud that we've taken this from $6 billion to approximately $14 billion in sales this year and that weighted average market growth rate without some big massive divestiture or some transformational M&A deal. So we continue to find ways. And yes, as the company gets bigger, you need bigger sales and so forth to continue that growth rate. But we just see with that slide -- my last slide that I showed in my section, all these spaces that were invested in today organically or through the VC portfolio to continue to improve that weighted average market growth rate. So clearly, a bigger balance sheet helps us. And we can do larger M&A and still maintain the same investment-grade ratings that we want and buy back shares to not have a dilution there on the stock. So clearly, they could get larger given the balance sheet, but they also could get largely got the size of the company. But we just feel like we have a good recipe and very good line of sight to how to grow really nicely beyond this LRP.

Great. And just one other specific question I was hoping you could expand on more product specific is ACURATE, neo and [indiscernible]. Mike, I know you like to win, you like to be a market leader. What are -- how are you framing your goals and aspirations for this area now? I mean -- and what do you hope to achieve? I think you're saying late '24 approval for -- in the U.S. What are your aspirational goals there?

Joe can comment after me. We are like most companies competitive. We care for our employees and our patients, but we work as a great global team, but we push each other to win. And in the ACURATE neo2, I like the fact that analysts aren't projecting much for us there currently. And I think what's most important is what in our side and Lance said is this is a very established product in Europe with a very good reputation without having the large eyes. And this is a product that we know how to make, we know how to improve. We've done, I think, our fourth generation. So it's something that's in our R&D wheelhouse, our manufacturing wheelhouse, the physician somebody we know today already very, very well. And the device is easy to use. It has got excellent clinical data, and we have a strong sales force to do it. So we're not going to give share estimates here. But we've been at this journey. A lot of this gray hair is in TAVI and we've learned a lot. And I absolutely believe we can be a highly competitive TAVI company.

Yes. I would add. I mean, if you look in cardiology, we know what category leadership looks like, looking at our CT business, looking at our high-voltage business, look at our WATCHMAN business. So we're not trying to figure that out. Now we clearly don't have -- I mean we're, let's call it, a rounding error in EP and in TAVR, but we know what category leadership looks like in terms of how you execute, what kind of teams you need, what kind of clinical teams in profit [embedded] -- so we know all of that. And as you heard on the EP side, when we do something like put AF solutions together, it's because we understand what we have to do to become a category leader in EP. So we're not going to give share estimates, but we're going to take what we know are our strategies and these phenomenal products that we want to deliver in '24 and then we'll go execute our plan, just like we have historically done across Endo, Uro, CT, high voltage, WATCHMAN, et cetera. So we know the playbook, you got to have the products. We love our current offerings both on the TAVR side with ACURATE Prime and our Farapulse technology, now we're going to go run the play.

Just an example, shout out to our PI team, I'm not saying we'll be closed -- we'll be -- we have very good competitors that are #1 and 2 in TAVI. But when we're Jeff Mirviss and Joe at the time we're talking about drug-eluting with the Ranger and Eluvia years ago, we're like, why are we doing this? We're like 5 years behind with Ranger and Eluvia. And now we're #1 in drug-eluting with our Ranger platform and Eluvia over multiple years. So I'm not suggesting we're going to be #1 or #2 in TAVI, but we're going to be very competitive.

Thank you. Mike, I'll hand it over to you to just close this down.

I can do the Q&A all day long. You keep shutting me down in the Q&A. Well, I don't have a big close here. I think Dan wrapped it up really well. For those who made the trip to Boston, we appreciate it. For those online -- who are still online, Thank you for participating. I want to thank, first of all, Lauren and our BSC team for pulling all this together. I'm feel like a proud papa, I guess, with the company. It's -- I'm very grateful to work here. And I know you have many different investor days you can go to and many different investment choices, but we are extremely committed to our high performance and doing the right things long term for the company. And hopefully, you see -- you leave with the same excitement about Boston Scientific that we all share every day around the globe. So thank you very much for attending.

Thank you. All right. I'm going to ask the BSC team to come up to the stage for a picture. For everyone else, slides are already posted on the website. Webcast will be available within 48 hours. And for those in the room, lunch is being served in the Olympia Room.