Thanks, everybody, for coming. I'm Lee Hambright, U.S. MedTech analyst at Bernstein. We are very pleased to host Boston Scientific today. We've got Chairman and CEO Mike Mahoney and Chief Medical Officer Dr. Ken Stein. Thanks so much, guys, for being here.
Pleasure.
For those of you in the audience, if you would like to ask a question, you can submit it via the Pigeonhole tool, and I will try to work in as many as I can here. So Mike, 2024 was another incredible year for Boston Scientific with 16.5% organic growth, 22% EPS growth. You had a great start to 2025 with 18% organic and 34% EPS growth in Q1, which sets you up for a strong year. Maybe you can just kick us off with a few thoughts on the state of the business at Boston Scientific.
Great. Thanks for having us, and Dr. Stein, thanks for coming as well. Just very proud of the high, very high execution of the company for many years in a row. As you know, our aim is to be the highest-performing MedTech company. We, I think we likely were last year, hopefully this year, and maybe the year before that. Our goal is to do that for the next five years. We invest, we spend time every day on hitting our near-term commitments and investing to have a differentiated future. You know, we can talk about that with our portfolio, but that's our 100% focus of the company. We're off to a really good start this year.
You know, just you saw the first quarter results, and despite the tariff headwinds, puts and takes in that one, we raised our full-year guide to at least 12-14. Also raised our EPS and enhanced our margin profile, margin improvement for the year despite the tariff impact. Really proud of the execution of our global team and the portfolio that we have and the momentum of the company.
Great. Maybe, maybe just broadly on macro, let's talk about the health of MedTech markets. MedTech market growth has remained pretty resilient, and stocks have held up well despite a host of macro issues, you know, policy changes, HHS appointments, cuts at FDA, potential Medicaid cuts, tariffs. Can you maybe just spend a moment talking about the health of underlying MedTech markets and then just put all of those macro issues in perspective for us?
Yeah. It depends really on where you are in MedTech, and it's overall healthy. The markets that we serve are extremely healthy, and that's been an intentional strategy for many years. Those who have followed us for a while, our weighted average market growth rate was 1% years ago, and now it's kind of around the 8% range. That's because of quarter-over-quarter, year-over-year focus on innovation and putting ourselves intentionally in faster-growing markets for the future. That's what we aim to do for the next five years as well. Our underlying market growth, at Boston Scientific, is very strong, and we happen to have a very unique position in what I think I will call the three largest, highest-growth markets in all of MedTech in the EP category, in the LAAC category.
I would add a new one, Ken, concomitant with the combination of PFA and LAAC, is extremely strong. Our weighted average market growth is about 8%. We've intentionally put ourselves in faster-growth markets, and that's what we will continue to do. The overall, you know, patient volume continues to be strong, due to aging demographics and so forth. There are a lot of macro headwinds. We've been able to navigate them with the tariffs, some of the cuts on the FDA and so forth. We've been able to manage those effectively. We have a very resilient team who finds a way to deliver differentiated results. We don't like these macro changes, but it's a good test for our team, and we navigate it well.
Yeah. Great. Maybe just hitting tariffs, now that you mention it, you're on your Q1 call last month, you sized tariff impact for 2025 at $200 million pre-tax, which is about 4% impact to this year's EPS. Obviously, this is still a moving target. It seems like the U.S. has walked back from the ledge a little bit on tariff negotiations with China and discussions being elsewhere. Any update to how you're thinking about tariffs or maybe an update on mitigation activities?
On the tariffs, we gave in our two-queue guide, it assumed, I guess, the European tariffs come back and the China tariffs were higher. We've had better news since then. That's actually a benefit for the company, our company, and most others. That's good news, and we'll update our second quarter guide in July, and full-year guide there. I think the tariff is certainly a better situation than we were, you know, when we gave our first quarter report. In terms of our global supply chain, you know, we're all over the world, and we are also a large investor in manufacturing in the U.S. We've tripled our Watchman capacity in the U.S. We just opened up a new facility in Georgia. We're also doing a lot of expansion outside the U.S. as well to meet the demand.
We have an excellent global supply chain team, and, ideally, the tariffs will become less noisy over time, so we can best allocate capital the right way.
Got it. Okay. Great. Before we get into other stuff, you issued an 8,000 this week.
Yes.
which we should hit quickly. You mentioned that, ACURATE neo2, you're discontinuing worldwide sales of ACURATE neo2. Maybe could you talk a little bit about what's behind the decision and how does that impact?
Yeah. I'll, I'll read a statement here. Obviously, tough decision for our team. We had the ADVENT trial that read out quite a while ago. We've had a lot of discussions in the U.S. and with regulatory agencies in the EU, and basically came out with this comment this morning. It says, based on ongoing discussions with regulators regarding the ACURATE valve platform, we've recently made the decision to discontinue worldwide, worldwide sales of ACURATE. We've also made the decision to not pursue U.S. FDA approval for ACURATE or approval in other unapproved geographies. While a difficult decision, we felt it was necessary based on the discussion with regulators, which resulted in increased clinical and regulatory requirements to maintain regulatory approvals in global markets and to obtain approvals in new regions. The investments and additional resources needed to satisfy these requirements are prohibitive for the company.
Importantly, given the strength of the company, despite the financial impact from the discontinuation of ACURATE neo2, we expect to achieve our previously issued second quarter and our full-year guide, both sales and adjusted EPS. It is disappointing. We really tried, but it is the right decision based on the increased requirements that the regulatory agencies have asked us to do in EU to keep it on the market. There was not a clear path that made sense in the U.S. We also have many different investment opportunities across the company, and we were best positioned from a capital allocation to move on into other focus areas.
Got it. Okay. Comment on rough sales, in Europe?
We've quoted full-year sales about $200 million.
Got it. Okay. Okay. The point is, in addition to the discussions with U.S. FDA, there were also discussions with European regulators, which led to the point that there'd be additional investment required to keep it on the market in Europe. Really, what led to the decision?
Yeah. It wasn't, it was the various regulatory agencies in Europe, varying degrees of opinions on it and the requirements to do extended registries that weren't feasible in some countries, the follow-up required, the cost of the investment, and also the burden that that would place on hospitals, and consent with patients didn't make sense. Given the trial in the U.S., it's time to make that decision and put our focus elsewhere.
Okay.
I think it's important to show us the strength of the company. We're not touching our second quarter full-year guide.
Great. Okay. Come back, maybe come back around to interventional cardiology in a few. Great. Okay. Let's zoom back out and talk about the LRP. You know, your last long-range plan from September of 2023 called for 8%-10% organic growth from 2024- 2026. You're obviously way ahead of that. 16.5% organic last year. You're cutting to 12%-14% this year. What's the best way to think about the next couple, two, three years, at this point?
The best way is to not think about that guide anymore, based on those results, really, because we're going to obviously do better than that. Things would have to just fall apart for us to not beat that guide. We'll give our 2026 guide, like we always do in February of 2026. We do have an investor day in September, which will give even more insight into our portfolio. The theme hasn't changed. Our focus is to continue to enhance our weighted average market growth rate and continue to out-execute our peer group, which we've done for many years in a row, and have the ability to deliver differentiated results, but invest like crazy in the future of the company to best position ourselves for the next five, seven years. That's what we're doing with our portfolio.
We're, our aim is to be highly differentiated over the next five years, just like we have the past three.
Got it. Okay. We just touched on gross margin. 2025, gross margin is now expected to be roughly in line with 2024, 70.3%. And, you know, I just wonder, could there be any upside there, if the tariff?
There's probably a little bit of puts and takes, and we'll give the 2Q more information on ACURATE. There will be some gross margin impact in the near term, with the ACURATE decision. If the tariffs continue to bend our way where they are currently, that would be some upside. There'll be some puts and takes in gross margin. Obviously, our goal is to continue to enhance it. Our goal is to get back to that 72.5% range. And we have key enablers that enable that, that others may not have as much. Just the mixed benefit and the strength of our cardiovascular portfolio is gross margin accretive. We continue to focus on VIPs and optimization in our plant network, and pricing's essentially roughly flat. There's a path to continue to enhance it.
There'll be some minor puts and takes with tariffs, maybe hopefully an upside and slight downside with ACURATE. We'll give the more guidance in the second quarter.
Yeah. Got it. I mean, you mentioned that 72.4% in 2019. You know, that doesn't have you getting back there over the next five years. Do you think there's a path back there, you know, potentially within that timeframe or?
We think the reason is to believe is the growth rate of the company and the mixed drivers within that. If you don't have that, it's not a clear path. You have unusual mixed drivers that are growing outsized. The markets are growing outsized. Our team's focused on productivity. There will always be some minor puts and takes, but our aim is to continue to enhance our gross margin over the period.
Great. Just a quick word on pricing. You know, pricing historically kind of 1% or 2% headwind in MedTech, but it's been a lot more favorable recently. You know, some, I think, companies have been pretty disciplined in the, in the face of inflationary pressures.
Some.
Wonder how long can that last?
I think it's, so it's most of its portfolio. There's always good actors and bad actors in the pricing environment, but most of it's mixed in portfolio. Again, because we're positioned uniquely in very, very strong markets, we have some markets that are less advantaged in price and juggling these tenants in CRM, but now there's such a very small percent of our portfolio versus years ago. The most benefit we have is mix. We are able to take up price a little bit in some markets, and some of our businesses have positive price, some have slightly negative, but the net-net is close to zero. We anticipate that price. I don't think it'll ever move to 2% or 3% favorable. I shouldn't say ever, but I think modeling kind of flattish price is the right place to be.
Got it. Okay. And maybe just touching on operating margin, you know, you're on track to deliver 50- 75 basis points of operating margin expansion for this year, which should allow you to get back to 27.6 for 2025. You know, you set expectations, I think, at the last LRP for 150 basis points of operating margin expansion over the next few years. You're kind of 28 by 2026. Is that still kind of the right way to think about it?
I'm going to take this one.
There's a lot of others.
Yeah. So the LRP we gave again was 150 basis points over three years, and it'd be hard not to beat that.
Yeah.
Based on what we did last year, and we are guided to 50-75. As you said, if tariffs help us and so forth, maybe we can be at the higher end of that range. We will see. Our goal has been the same thing. Maybe it is boring, to outgrow our peer group in a significant way and drive operating income faster, faster growth in sales. With that, we have shown over time the ability to consistently improve margins while delivering in the short term. I think you have to look at our track record. Now that, given the favorable product portfolio we have and the favorable markets, it would be highly disappointing if we did not find a way to continue to improve margins over the next five years.
Yeah. Excellent. Okay. Cool. Let's get into the fun stuff, talk about the businesses. No surprise where we're going to start on Farapulse. Farapulse has been obviously a great success story, perhaps one of the best launches in MedTech history. It's hard to build a product that changes the standard of care in a way that's faster and safer and more effective. You've done that with Farapulse. Maybe, you know, for the generalists in the crowd, you could reflect a little bit on why you've called Farapulse the most transformational product in your career and what makes it?
Yeah. You can do all the, I'll jump in after on all the other stuff. I'll just get one in before. It's so gratifying for me because we, again, our venture portfolio, we have the largest venture portfolio in MedTech. And I think that's going to fuel, fuel a lot of the unusual growth drivers, differentiate growth drivers for the future. And this came from that venture portfolio. So we stuck with this company for about 9, 10 years prior to actually getting approval through ups and downs. And we helped them. And we can, we aim to do that with other opportunities that we have. It's just in, in MedTech, you rarely see an overnight transformation. MedTech's typically a bit more incremental. A good friend of mine's having a PFA this morning in Cincinnati.
It's, I've never seen a product transform, in we've launched it 13-14 months ago, a practice from electrophysiologists. And for the generals in the room, you need an AFib ablation, you're likely going to get a PFA and likely going to get Farapulse. And it's a safer procedure. It's extremely effective, and it's very efficient for the hospital system and the doctor. Reimbursement's also being rewarded. We expect an additional 9%-10% increase in reimbursement for the hospital, similar to what we've seen with Watchman. It's just a product where referring cardiologists, referring physicians know about it now. And doctors are so confident and can comment more.
One of the most rewarding things I've seen, I've heard from EPs, I spent a lot of time with EPs, is it's rejuvenated their career, because not only are they more efficient, but they sleep better. They don't worry about adverse events. They don't worry about how the patient's going to do the next day because the safety profile's so strong and it's so effective. Our operations team has done an amazing job of staying ahead of the demand of this product. We have a lot more to do in the U.S. We have a lot more to do in Europe. We're just starting. We're like in the first inning in China, and we're in the very early innings in Japan. There are other segments within EP that we want to expand into. I'm sure Ken will add on more with the other questions you have.
Great. Great. Yeah. Kenny, we can get into the launch a little bit. You know, growth has been phenomenal. It seems pretty clear that Farapulse is set up for very strong growth over the next few quarters. I think the biggest question that comes to mind is, how does Farapulse perform as comps get tougher? You know, what are you seeing out there, with the launch?
Yeah. No, the growth has been phenomenal. And it gets to a number of things. That gets to your question, right? I mean, what's so transformational about Farapulse? It is unique in my experience in having something that is faster, that is safer, that is at this point clearly more effective than traditional means of ablation. I think, as Mike said, it's very straightforward to use, right? Reduces the cognitive burden. You know, AF is a remarkably common arrhythmia. Again, just to set the stage again for the folks who don't do MedTech all the time, there are best data, but 10 million people in the United States alone who have atrial fibrillation. Penetration of ablation to treat atrial fibrillation today, probably in the low single- digits for paroxysmal AFib. That's AFib that comes and goes.
High single- digits for persistent AFib, AFib that comes and doesn't go. I mean, I say this and our IR team hates me for saying it, right? It's a market that's effectively infinite in size, right? There is a huge runway for a lot of growth. Farapulse came into that, and it's such a win-win for everyone, better for patients, better for docs, even at a premium price with our latest generation technology, the NAV-enabled Faraway catheter. Our second generation Farapulse catheter linked with our mapping system, Faraview on Opal, is actually more economically advantageous to hospitals than traditional means of ablation. We have very rapidly seen uptake. We've disclosed previously more than 200,000 patients worldwide have been treated with the system.
We've published clinical data in over 20,000 of those patients. In Japan, where we only launched late Q4 last year, and in spite of not having first mover advantage in Japan, we've already treated over 10,000 patients. I think, you know, there is a very long and very wide runway, as long as we can continue to develop the app capacity that's necessary to deal with all these patients.
Great. Great. There's a nice productivity story with Farapulse. Maybe you can speak to that a little bit. How are you seeing that play out in the real world?
Yeah. You know, one of the advantages of the system, and it really all comes back to design. It's this decade of development that Mike referred to, is it is a safer system because it's safer, right? You, the workflow to do the ablation becomes a lot more simple, a lot more straightforward. You know, what we typically now are seeing, procedures that used to take one to two hours to accomplish, done in a lab in, you know, call it 30-40 minutes. What that means is, right, the typical cath lab in the United States is adding on 20-25% folks who are really pushing workflow, maybe doing close to doubling the volume that they've been able to do previously. It also gets to the concomitant procedure that Mike mentioned.
When we're talking about concomitant procedures, we're talking about treating patients with atrial fibrillation, both with Farapulse to restore normal rhythm, but also Watchman, left atrial appendage closure to help prevent stroke, which is the other, you know, major risk patients with atrial fibrillation have. You know, when you take these two procedures together, which again, you go back legacy, you know, may have been an hour, hour and a half each, right? Now you can do them both at one sitting. Patient is exposed to one set of risks, typically under an hour. That's part of what's necessary, right, to create the capacity that we need to deal with these millions of patients.
Great. You know, you're driving rapid adoption, obviously lots of conversion from cryo and RF. You now expect PFA to likely exceed 60% of global AF ablations by 2026. What's the latest thinking on that metric? Do you see any rate limiting factors in the medium- term and long- term for growth?
Yeah, Lee, I think again, 60% in 2026 is what we're estimating. Say 80% by 2028. Frankly, you know, there ought to be a future where no one gets an AF ablation using technology other than PFA and we would say other than Farapulse. Again, the only rate limiting factor to growth at this point is going to be lab capacity.
Yeah. Got it. Okay. So at AF Symposium in January, you presented some data from the first phase of Advantage AF, which studied Farapulse for PVI and PWA and persistent AF. That persistent indication's on track for the second half. Maybe can you talk just a little bit about how you think about impact from that indication expansion?
Yeah. To clarify for everyone, right, currently labeling for the Farapulse system is for paroxysmal AFib, AFib that comes and goes, not for persistent. In spite of that, we're already seeing a very large amount of off-label use in the United States and frankly globally. I don't know that getting the label is going to have a material impact on growth of Farapulse. I think what people are going to see is just getting the data out there is going to help drive referrals, right? As I said, persistent AFib, it's still single- digit penetration because up until now, referring physicians have been concerned, is this a safe procedure? Farapulse, yes, it is. Is this an effective procedure? Because traditionally, it's been much harder to ablate persistent AFib than paroxysmal AFib.
The data that we just presented from Advantage really shows extraordinarily good long-term success from the ablation. We're down now to single- digit redo rates in Advantage patients with persistent AFib. That's something that no one has ever been able to show before with any, any kind of technology.
Great. Just thinking about upcoming approvals, Farapulse FDA approval is expected in the second half of the year. We can talk a little bit about what that adds to the portfolio.
Yeah. Let me say two things about just the overall catheter portfolio. Ferapulse is our point ablation catheter. We pay people in marketing to clean these names up. It was also studied in our Advantage phase II clinical trial as an adjunct to the Faraway catheter to a very specific purpose of ablating an arrhythmia called atrial flutter as an adjunct during an AFib ablation because those two are just very common companions of each other. You know, the advantage of Ferapulse that we showed in the data in Advantage is that it, again, was very efficient and very effective at achieving something called DTI block, which is what you need to do to ablate atrial flutter.
I think from a broader standpoint, I think really important to point out, you know, we've said, Mike has said, right, that the Faraway launch, you know, may be the single most successful new product launch in MedTech. We are really not stopping there. I think it's really important for us to continue iterating the entire catheter portfolio. It is why we already have a second generation Faraway catheter out in the market, third generation in development. We have different catheter form factors. The Farapulse in development, again, expecting approval second half of this year. Catheter called Faraflex, which is designed to be a quote unquote map and ablate or a large focal lesion catheter, that's already in its first human use clinical trials, and expecting to begin pivotal trial for that later this year.
We're not just resting with Faraway, right, but continuing to develop the entire catheter portfolio as well as the mapping ecosystem, the ultrasound ecosystem, right, the things behind that to support the entire product line.
Just one follow up on Farapulse. You know, I've heard some clinicians like to use RF for CTI lines because they worry about coronary spasm with PFA. Can you just comment on that?
Yeah. There is a phenomenon actually with any kind of energy source that's applied in close proximity to a coronary artery, that the artery, just like any muscle, it gets irritated, it'll spasm down. It's not unique to PFA, not unique to Farapulse. What we did and really what was part of the point of that Advantage phase II clinical trial data is we showed that with just simple pre-medication with a very common drug, nitroglycerin, which if you're not in medicine, sounds terrifying, but it's not. It's standard use for people who have coronary artery blockages, that very safely, very effectively mitigated the issue of spasm. Really, you know, from our standpoint, not a concern as long as people are pre-medicating with nitro.
Got it. Okay. Maybe just one point on AvantGuard, which you completed enrollment for in first quarter of 2025. Can you just talk about the significance of that trial and what that brings to the story?
Yeah. Very excited about the AvantGuard trial. As you said, as you just heard, you know, completed enrollment earlier this year, expect to have the results out first half next year. AvantGuard is a very different kind of an ablation trial, right? It's not just to qualify and get a new catheter approved. It's actually to prove a new strategy, which is to show that ablation using Faraway for persistent AFib should be the first line of defense. And so it's early intervention instead of giving patients, which is what's typically done today, a trial of an antiarrhythmic drug. So randomized AF ablation first line against antiarrhythmic drugs.
The hope is that, you know, should that trial be positive, and we're very optimistic about it, right, that that will drive earlier referral in, and that will also help us to get away from that low single- digit penetration in the persistent AFib population.
Got it. Okay. Maybe last one on pipeline products, Faraflex. So Faraflex is your large focal catheter, sort of a similar shape to the SpheroNine catheter. Just what role does that play and, and what are your expectations for Faraflex?
Yeah. So Lee, the goal here, right, is to give the complete toolbox. Again, I don't golf, but the people I know who golf never got with just one club, right? I think, you know, key to success here is providing, right, the whole suite of tools that an electrophysiologist may need. Now, you know, for a first shot ablation, where typically what you're doing is something called just pulmonary vein ablation, and typically for persistent AFib, also posterior wall ablation, we really think there is no tool better than Faraway. As you get into more complex arrhythmias, there can be a need for different types of catheter form factors. That's Farapulse for redo ablation, right, where you may need to just hit very targeted areas of the atrium, right? You may want something like Faraflex where you can map and ablate.
As we get to other arrhythmias like ventricular tachycardia, again, other form factors become more important. I think important to state, however, you know, we still see Faraway as the workhorse catheter. Again, just getting back to our more recent data, you know, these redo ablations, which used to be a really big chunk of the ablations that electrophysiologists were doing and that require these much more sophisticated tools, you know, we're down into single- digit redo rates now when people use Faraway as their first shot.
Great.
I try to simplify it a bit more, and he maybe thinks it's wrong, but if you look at the pie chart of types of ablations, two thirds of them, the PVI and posterior wall, there's no better product available than Farapulse. The one third, that's where we have the additional point catheter and Faraflex, which is more optimized for that one third.
Maybe speaking to that one third a little bit and talking about the competitive landscape, you know, you have one large competitor who's struggled with some supply constraints, but is kind of just getting off the ground in the U.S., maybe targeting some of those more complex cases to start. What are you seeing out there from that competitive launch?
You know, I would say our competitive position is stronger now than we thought it would be, 15 months ago, given some of the challenges of some competitors and the fact that I mentioned earlier, we've really done a great job of rolling out Farapulse across the globe and opened up so many centers. It's going to be very difficult to beat that product for that two thirds of the market I just highlighted. That one third of the market, that's where we're going after with the Farapulse catheters we launched this year and our Faraflex catheter. We think we have such an unusual head start. You can't do this across every division, but we've put, as you might expect, more attention and focus and dollars and investment in this category along with Watchman and Concomitant than we do anywhere else.
We are leading the clinical trials. We've got a beautiful cadence of products. We have multiple venture bets to further augment it. We're expanding in new areas with ICE. This is the biggest market in MedTech that grows the fastest. We have the lion's share, the lead. The market's underpenetrated, so there will be more competition, but we've got a terrific head start and a great portfolio.
Great. Maybe one question about dual energy and RF and where does RF go? You know, some clinicians have expressed an interest in having that dual energy option, being able to use RF for certain parts of the procedure. Do you think that's important?
Yeah. I don't think so at this point. I, I, again, you know, if we wanted to put RF on a catheter, I mean, it's very easy to do. There are still going to be some very, you know, isolated arrhythmias where RF is going to be the best choice. We have yet to see a use case where you need both in the same catheter, and there are inherent design trade-offs in doing it. You know, docs who are interested in it are interested because they think you can get a catheter that's great at both, but you can't. You know, our design philosophy is, you know, let's make the world's best PFA catheter, which we've done, and let's treat any arrhythmia where you need PFA with PFA with a catheter with the right form factor. That's Faraway, Farapulse, Faraflex.
and if you ever, for whatever reason, need to supplement that with RF, then take an RF catheter that's designed to be one of the world's best RF catheters.
Gotcha. Okay. Great. Maybe wrapping up on PFA, you launched Farapulse with kind of agnostic strategy with respect to mapping. You have now got a mapping product that you are rolling out. Can you comment a little bit just on the importance of mapping and how the mapping launch is going?
Yep. The mapping launch is going very well so far. I still think it is important to say that we will still be agnostic. For people who want to do cases without mapping, which is very common in Europe today, and, you know, the more cost constrained your environment is, the more you'll see that used. We're very happy to support those cases. If people want to do our case with a competitive mapping system, you know, we are not locking down. We're leaving that as an ability. What we're trying to do is, again, create a mapping ecosystem, right, where we do not have to force people to use our mapping system. We want them to want to use our mapping system. The launch to date of Faraview on Opal has really exceeded our expectations.
Great. Okay. Moving over to Watchman. Watchman hit $1.5 billion in revenue in 2024. Growth's been consistently strong, 24% in the first quarter, driven by the concomitant opportunity, which you mentioned. You know, you updated on the Q1 call that over half of U.S. EP implanting customers have now performed at least one concomitant procedure. If you can just reflect a little bit on the rapid uptake in the field, what are you seeing out there with concomitant?
I would say it's still super early, but we've seen a very nice switch even over the last six months of physicians who, you know, prior to the concomitant approval and prior to the concomitant reimbursement, you would have anticipated very low penetration rate. The adoption is quite strong because of the safety profile of Watchman Flex Pro, the safety profile of Farapulse. We already have Baylis, the transseptal crossing platform. It is a very efficient, safe procedure. As Dr. Stein said, you ideally cure your AFib, you reduce the risk of stroke, and you give patients off blood thinners. Who wouldn't want that? We continue to have an opportunity to train many more EPs to do the concomitant procedure, which we're doing.
It's not popular outside the U.S. yet, given indication and reimbursement, which we think our aim is to change that over time to make it as strong in Europe and Asia Pac as in the U.S. It is very early innings. That is what I mentioned before. If you look at the, I hate the word competitive moat, but I guess I'll use it. You have the, I think the three best markets in MedTech are EP, LAAC, and the emergence of concomitant. If you look at the growth profile for many years to come, there are no better markets to be in. We were fortunate to have earned a leadership position in both LAAC and Farapulse. When you have the combined procedure that requires both products, we are uniquely positioned to offer that. Many of our competitors do not offer one or the other.
We want to continue to invest in making that procedure more optimized, easier, train more physicians. It also helps solve for just the constraints the healthcare system has. You know, bringing a patient back twice, anesthesia twice, lab time twice, it's very inefficient. We are really grateful that the reimbursement is now in place as it should be to have the procedure, both procedures done very effectively at the same time.
Great. The Champion trial has become an increasingly important part of the story. Obviously, huge potential market expansion, indication expansion for Watchman. Can you just talk a little bit about the importance of Champion and how to think about what that means for the business?
Yeah. So Champion is our first line trial, Watchman Flex against the, you know, so-called NOACs, the, the new, not so new anymore, oral anticoagulant medications, you know, like, Eliquis, Xarelto, things like that. And we expect to have those data reported out first half of next year. The goal here is to show that we've got comparable efficacy to taking pills every day for a life, and to be able to show that there's actually less bleeding over the long- term with Watchman than if you're taking on those medications. You know, and, and should we get those results, right, that, that has a number of really important impacts. I mean, first of all, it can quadruple the size of the indicated population for left atrial appendage closure.
and then it also, you know, would get us, we feel confident, better representation in international guidelines, help unlock the international market, get it, get it to the point where international use of Watchman comes close to what we see in the United States, and also enable us to get a more favorable national coverage decision from CMS, the United States, you know, to cover reimbursement for the procedure as a first line option.
Great. Maybe, maybe we can shift over to interventional cardiology for a moment. You know, you've had a very successful interventional cardiology business for a long time. You've grown that complex PCI business really well. It's now much larger than the drug-eluting stents business. With the news this morning about TAVR, just a question. Can you be the leader in interventional cardiology without a TAVR asset?
I would say I, we are the leader in coronary intervention. The team has done a remarkable job. It's, again, it's all about portfolio management and putting yourself purposely in the fastest growing markets. That team, which was overweighted to drug-eluting stents years ago, has essentially reinvigorated a whole imaging platform with our imaging platform. We've also reinvigorated the first market with the Agent drug-coated balloon. Now we're doing new studies to widen the indication of that to make it, you know, potentially at least a billion dollar market opportunity. That business is growing essentially at double digits. The team has done a terrific job as the leader in coronary interventions of continuing to focus on unmet needs. We've recently acquired, as you know, Bolt, to treat, to go after a competitor there to further round out that portfolio.
We have approval for above the knee and peripheral interventions now and below the knee next year. We just started our clinical trial. We also acquired an early stage company called Sonovy for hypertension, which potentially could be a nice market depending on what happens with the reimbursements, private pay market and so forth. That is a differentiated hypertension. That business goes there. The area that we are less good at for sure is aortic valve replacement, TAVR, and mitral and so forth. That is a gap. We have a number of really compelling venture plays in those areas that we will see over time whether that makes sense based on the progress that they make. Our focus continues to be on category leadership and putting ourselves at faster growth markets.
I think our interventional cardiology story, taking it from a very low single- digit growth to close to double digit most quarters, is a great example of our portfolio management execution of the company and leveraging our internal R&D and our VC portfolio. The largest investment we have in the company is in interventional cardiology, called Vitalist, which is our circulatory support system where we've done about 30 patients successfully in VFS. We'll start the U.S. clinical trial for complex PCI and then for shock. That's a longer term investment, but we're very bullish on that market. Again, some players have point solutions in these markets. We have a very comprehensive portfolio. When it comes to contracting and partnering, you want to have a comprehensive portfolio to leverage and partner with hospitals, and that's what we offer.
Got it. One more on TAVR. You know, with Lotus and now Neo2, you know, is this the end of the road in TAVR? You know, is it possible that you kind of go back and take another shot there?
You know, we'll see. Four years ago, you would have said you should shut down your EP business, because it was $400 million and not growing and not making any money, hardly. Then we had, we invested smartly, in Baylis and Farapulse, and it worked out. You never say never. For us to get back into the TAVR market one day, it would have to be a compelling platform that we think would be differentiated. At this point, you know, we'll continue to scan, but I would never say never. We'd only do it if we felt like it could make a meaningful impact. Given the, and the reason I say that would be, we have so many other investment areas across the company. It would have to be one that would be compelling.
Yeah. Got it. Structural heart more broadly, you know, where does that rank in your priorities? I mean, it's obviously a big growing market, a place where you have less exposure. Is that an area where you want to take more shots on goal?
We consider LAACs kind of in the structural heart area. We're kind of all in on that, as you know. And as you may, you know, we have multiple VC investments, a few of them with fixed options to buy if we want to, if they make progress, across tricuspid and mitral. As you said with TAVR, the TAVR market's still healthy. It doesn't grow as fast as it used to. It grows a little bit below our weighted average market growth rate as a company. The only way we would enter that is if we felt there was something disruptive.
Got it. You mentioned the venture capital portfolio. You've got a growing VC portfolio. Many of your most successful acquisitions have come out of that portfolio, including Cameron Health years ago, Preventis, Farapulse, of course, Bolt more recently. Can you just comment on that portfolio? How important is that to your future, and how hard is it to be good at investing in this?
I think we're not perfect. We're, I think we're better than many. You're going to have some setbacks because they're, by nature, they're early stage. They're typically more disruptive. There's going to be, you know, some that work out and some that don't work out. We've gotten pretty good at it over the years. Our portfolio now is larger and more exciting than it's ever been, and primarily weighted across the cardiovascular landscape. We have some very exciting VC bets in urology as well as endoscopy. I think as the company continues to get bigger and bigger, we can walk and chew gum at the same time. We can deliver high performing results and invest in the long- term while improving margins. The VC portfolio allows us to have a good look at these companies.
When they don't work out, we're able to manage the dilution if we have some equity accounting in there. The payoff is quite large, and it frees up our team to continue to enhance our core portfolio. We do traditional tech and M&A. For our R&D teams, they don't look at it as we're losing out, we're doing a VC deal. If we buy the company, that product will come internal to our R&D teams. Our R&D teams are very much in sync that our best thing we can do is create more shots on goal, treat more patients. Oftentimes we'll have an internal technology that we like a lot, but it won't get the investment required to bring it forward at a proper time frame.
We'll spin that technology out to a third party, invest in it, see how it goes, and bring it back in. We have a lot of motivation across the team not to be protective, but what can we effectively fund efficiently? If we can't, let's spin it out or let's do a VC opportunity.
Got it. You touched on Bolt Medical. You announced that deal back in January. It gives you exposure to the exciting intravascular lithotripsy IVL space, which was, of course, pioneered by ShockWave. Maybe can you touch on that a little bit and talk about where Bolt is in its development journey?
Yeah. We're very excited about that. We initially started that company. That was the story I just said. Initially with some IP, moved it along a little bit, realized we couldn't fund it, given other priorities, spun it out. Keegan Harper did a fantastic job with it. It's a terrific platform. It has approval for above the knee. We will start launching in probably late fourth quarter for peripheral vascular above the knee. It has some differentiated features, in cardiovascular where the largest part of the market is in terms of its number of emitters, its ease of use, and also the ecosystem that we're able to place with it. With Boston Scientific, you can see the issue with our IVUS imaging. You can prep the vessel with our various products or with Bolt, and you can treat the vessel.
Beyond it being a differentiated product for IVL as a standalone, doctors look at it as treating a patient. The portfolio that we have will be very difficult to compete if you have just a standalone IVL product.
One question from the audience. What changes are you seeing in your engagement with the FDA on the back of some of the recent cuts and things?
Yeah. You know, frankly, in terms of our review cycles and products that are under review right now, not much of a change. You know, the things that were covered under MDUFA with user fees, they fired a whole bunch of people, but then they rehired all of them. So I’d say not too much of a change there. Longer range, still a little bit of a wait and see as we look at what some of the impact is, you know, maybe at some of the offices of innovation within FDA. But today review teams are largely intact, and, you know, we really haven’t had any particular difficulties with any of our submissions that are under review right now.
Great. Quick one on M&A. Lots of activity recently, Silk Road, Axonix, Cortex, Bolt Medical, Intera Oncology, Sonovy. Can you just talk a little bit about the path going forward? You know, do you need to take a pause here after all those or you're good to go, keep firing away?
We're good. We're fine and good to go. It's, we, we've, this has been our recipe for many, many years. With our VC portfolio and M&A, it's all about putting ourselves in faster growth markets and expanding our category leadership so we can partner with customers better. And that's exactly, all of those fit into that category. We think that playbook's smart. We're effective at it. We're very good at doing integrations. We know when to stop programs, as you know. Maybe this one took us a little while longer. That's the playbook that works really well for the company. We're in enough businesses with so much unmet need that there's plenty of things to look at.
Let's talk about size of the company for a sec. So you're in a really nice kind of size right now, about $17 billion revenue. You got a bunch of growth drivers that can move, really move the needle for you. Sometimes when companies get too big, they get a little cumbersome and harder to manage. How, how do you think about the path forward? I mean, would you ever consider divesting some things that, that don't make sense or don't grow as fast?
We always look at it. There's nothing top of mind that we want to do at this point. But, you know, we were $5 billion. Now we're $17 billion, and we'll be quite a bit bigger than $17 billion at the end of this year. So the company has gotten larger, but I think we've proven that as we continue to get larger, we can walk and chew gum at the same time. We can still be very agile. You have to focus every day on how to get better, how to reduce bureaucracy, how to make the company more agile, and have that very intentional part of your DNA. If you don't do that, then you become a bigger, slower company. But we are not going to be that.
We have the innovation cadence and the mindset to, despite getting larger, continue to grow at a highly differentiated rate and improve margins. We have the portfolio and the people to do it.
Okay. Maybe just wrapping up, Mike, you know, over your time at Boston Scientific, you've really transformed the company. The stock has performed exceedingly well. What's left to accomplish? You know, how do you think about the next five years, next 5, 10 years?
It's easy. It's an awesome company. It's a great industry. Our goal is, my goal is to have the most differentiated company for the next five years, the next seven years. There is so much patient unmet need. It's a great business. It's competitive. We have a phenomenal team. We do not look back at last quarter. We are focused on how do we get better today and how do we become, how do we differentiate in 2030. We are able to do that. Our team is very committed to that. It's very inspiring. That is what we want to continue to do.
Yeah. Thanks, guys.
All right.
Good to see you.