Okay, everybody. We'll jump in here. So thanks for joining, Lee Hambright, U.S. MedTech Analyst at Bernstein. We're very pleased to host Boston Scientific Chairman and CEO, Michael Mahoney, and Chief Medical Officer, Dr. Kenneth Stein. Thank you both for being here.
Pleasure.
For those of you in the audience, we, if you have questions, you can enter them in the Pigeonhole tool, and I will make sure we can hit as many as possible here. Maybe just to kick us off, you know, 2023 was a great year for Boston Scientific, with EPS growth, and you started 2024 strong. Impressive, 13% organic growth, 20% EPS growth again, in the Q1. Sets the company up for a strong year. Maybe you can kick us off with just a few thoughts on the state of the business at Boston Scientific.
Sure. Well, good morning, and thanks for hosting us, and bright and early here. State of business is quite strong. As you know, we ended 2023, we had a good year last year, and we just recently raised our guidance at the end of the Q1 call. And just really proud of the global execution. You know, we've had every region growing digits Q1. Emerging markets are nicely accretive to our growth rates overall, but every week, Asia, Europe, U.S., Latin America. And then we also track, you know, how we do versus peer group. And now that is growing about 6 of our 8 businesses, double digits in the quarter. It's a broad base strength of the company.
And, you know, the vast majority of our businesses grew quite a bit faster than our peer group in the segments that we compete in. So that's terrific. And also we have underlying strong market demand for our products. And, every year we've showed at Investor Day, we've increased our weighted average market growth rates in the markets that we compete in, from what used to be a 0 number, 10 or 11 years ago, to now markets that are growing, you know, probably 7-8-ish. So we've really done a great job, I think, overall in the portfolio over many years, of putting ourselves in high growth markets, and we have an excellent innovation cadence within the company right now, and the team's executing.
It's a great time to be at the company.
Excellent. Excellent. All right, you touched on market growth a little bit. Market growth has been strong in MedTech. You talked about the strong procedure backdrop across your businesses. I think some investors worry a little bit that market growth could decelerate when the COVID backlog recovery tailwind starts to peter out. Can you speak to that a little bit?
I t's not a concern of ours, and Ken's probably going to talk about Farapulse a bit. You know, we see a consistent wait list for treatments. You know, if you go to most hospitals in the U.S. or ASC, 90-20 days. In Europe, a public market could be a 9-month wait. So we see a high demand and we're now in markets that there's just, there's excellent supply of patients, and we don't expect a cliff procedure volume. We have not seen a significant slowdown in the wait list, the procedures that we compete in.
Maybe speculate a little bit as to, you know, if it's not, if it's not backlog, strong growth, what, what else could it be that's driving such strong growth in the market?
Well, there may be a touch of backlog, but I think one is just in the markets opening patient awareness. You know, even in our urology business, we've done a great job of creating more patient awareness on erectile dysfunction, and we have traditionally a 2%-3% growth market that's not growing upper single digits, driven by patient awareness focus. With AFib, everyone has to watch it appears population is more aware of AFib and all the diagnostic tools as itself. It's just makes patients more aware of issues. So I think it's a combination of maybe a little bit of COVID overhang. Patients are sicker and just general some diagnostic capabilities that are driving the patient demand.
We're, we're two-thirds of the way through Q2. I know you can't talk about the quarter, but are you seeing any changes to that procedure backdrop versus the strong start for your markets in the Q1?
No, we continue to see nice volume.
Okay, your long range plan calls for 8%-10% organic growth from 2024 to 2026. You're already tracking ahead. You know, as you said, you guided a 10%-12% organic year. Do you expect growth in 2025 to actually accelerate versus 2024?
We'll see. It's a bit early to call that. Obviously, we write 2025 guidance later in the year, and so we're pleased that we enhanced our full year guidance in 2012. We'll do, you know, we'll do everything possible to deliver that and exceed it if we can. We'll 2025, and so we have more data.
Great. Price has been a, you know, percent med tech historically, but it's been more favorable recently. Flattish. It seems like companies have been pretty disciplined in the face of inflationary pressure. How long can that flattish pricing environment last, and do you think we might return to that 1%-2% headwind we normally see?
For us, part of it is the discipline around pricing, terms, contracting, and rebate management. And some of our businesses can drive better pricing uplift than others can. And so that's where we're seeing a nice improvement. The other big equation for us is just the portfolio mix of business. You know, whenever you have new innovative products and you have healthcare economics and clinical data that supports that, then you can get a higher price point for those products. And so we've really done a terrific job of transforming our portfolio and the mix of our work. And a much smaller percent of this will be less than 4%, I think, by the end of the year.
But then you have products like Agent, which we're going for an NTAP and a TPT, products like Farapulse and many others, like Apollo, a recent acquisition, Astropy. So the benefit that we receive, supported by clinical evidence, healthcare economics also is a big part of it, besides just, better pricing. So net-net, you know, we're maybe slightly negative, but we think that slightly negative to flatish is what, you know, we consider for our, three-year plan.
Okay. A couple questions on margins. 2024 gross margin is expected at or slightly below the 2023 level of 70.7%. It was below 70% in the Q1, driven in large part by all the capital placements for Farapulse, IVUS, and Lumenis lasers. I know Dan is maniacally focused on getting back to that, 72.4% pre-COVID level. Consensus doesn't have you getting back there over the next 5 years. Can you just talk about the path back to that?
Hopefully, we'll surprise people then. That's our goal, is to get back to where we were. We laid out 150 basis points of improvements over that 3-year period. I think 30-50, we claimed for 2024. You know, the growth parts have been impacted by elements. One is just the capital places, which are great investments for us for the future. We've also had, you know, pretty significant mini companies costs in the products that we supply to customers. But we have a lot of confidence in our operations team, and we've really, I would say, mid-term COVID, we slowed down many of the value improvement programs and engineering programs for sustaining that drive costs.
That's really, that's amped up quite a bit over the last 12 months. I think this year, you know, the guide's unchanged. We're trying to get back to that, 2023 level, but we're certainly pushing the team over time to get back to that, historical rates of close to 73. Take some time.
So, you know, like, like you said, despite where gross margin is, you're committed to 30-50 operating margin improvement this year and 150 bps of LRP. When you think about balancing growth and, you know, profitability, does that, you know, that gets you pretty close to 28 by 2026. Does that feel like, still feel like the right place to be?
I think the 150 basis points we laid out is a really good target for us. And that balance that you said is one of the tougher parts of the portfolio choice making, and that balance is always tricky, but we feel like it's really good hygiene for the company to drive leverage. And we've consistently done that, and our business leaders understand that, and our operations teams understand that. And whether even when we do tuck-in M&A, we find a way to ensure that we keep that margin story alive, and find ways to make appropriate cuts or portfolio trade-offs to do that while maintaining what we call the best-in-class organic sales.
Okay, great. All right, get into the fun part on the businesses. Maybe before we get into details on Farapulse, it might be called Farapulse, the most transformational product that you've seen in your career, Boston Scientific. Maybe for the generalists in the crowd, maybe can you just reflect a bit on why Farapulse is so special and what it means to the broader story, Boston Scientific?
Sure. Well, again, we have a broad story because the Farapulse and Watchman tend to drown out great businesses like, and I'll get there. Like endoscopy, urology, peripheral interventions, interventional oncology. Our core coronary business is growing double digits. So we have many growth drivers and many products that continue to enhance that. But clearly, Farapulse is a unique platform, and Dr. Ken Stein's an electrophysiologist, he can speak to it. But I'm really proud. This is a company that we were an angel in 2011, and we really went after it because in med tech, it's difficult to get things that are exponentially usually a little bit better, the products. And this is a procedure that's the fastest growing med tech market. It's about a $10 billion market.
This particular category is about a $6 billion market, and we think that will likely double by year-end in 2027. It's the fastest growing market. This segment is going to grow +20%, and it's a procedure that's safer. Ken Stein can talk about the clinical data, actually proving superiority versus the current standard of care, which is radiofrequency. And it's also very, very efficient. So hospitals want that patient back often, and do their work very safely and with great efficacy and improve productivity at the halfway, which is excellent. And thankfully, we invested in this company many years ago. We've got a nice head start against the competition, who are typically promoting legacy catheters that they're now putting PFA on.
We have quite a bit more experience for them, and we have also invested heavily in our supply chain over the last years to meet the demand that increasing.
...So it's a fun market for us. We have not been a market leader in this category. We're number 4, but we have great customer relationships with electrophysiologists through our Watchman business, second. So, it's a very common procedure, and, beyond Farapulse, we have the most comprehensive portfolio to wrap around that physician to treat the patients with disorders. And so it's a terrific product. It's easy for physicians to pick up, and, once it's in their hands, they want to use more and more of it.
Excellent. Let's get Dr. Stein involved a little bit. So U.S. launch began in the middle of Q1. You had approval in January, started launching in the middle of the quarter. You know, you're off to a great start. As you, as Mike said, you're not supply chain constrained. You know, you're seeing more point-by-point RF users adopting Farapulse so far than cryoablators. What, what are you seeing in the field at the moment?
As Mike said, we literally could not be happier with how this launch is going, and a lot of it comes down to execution by the teams. A lot of it comes down just to really the unique, differentiated features of Farapulse as a product for ablation. Maybe just a little more color on what Mike said. Again, if you don't follow this area as closely, right? Atrial fibrillation is the most common sustained heart rhythm disturbance in the world. 1 in 4 U.S. adults over 50 will experience it at some point in their lives. It's not unique to the U.S. Same patterns internationally. Medical therapy for AFib is almost uniformly poor results, right? Can result in stroke, result in dementia. We take years off people's lives.
And so ablation technique, right, where we basically, prior to Farapulse, cauterize, burn away the tissue that's around the vein, empty blood from the lungs into the heart. And that is highly effective. But as Mike said, the way it's traditionally been done, it's a difficult procedure, it's a time-consuming procedure, and there are some really important risks associated with it. And the unique thing about Farapulse is that it's a non-thermal way to destroy this tissue of atrial fibrillation. There is no doubt at this point that it is safer than traditional techniques. There is no doubt at this point that that is considerably more efficient, faster. It's a very straightforward procedure to employ. And then we had data that was presented just at the Heart Rhythm Society meeting last weekend in Boston.
That's the first time that anyone's shown that this energy source is actually superior to traditional ablation in terms of efficacy, in terms of preventing recurrences. And so again, we've seen electrophysiologists pick this up, I guess the right word is, as enthusiastically as you can imagine. And going into the launch, I think a lot of folks outside of the company thought that this would appeal primarily to people who are using a technique called cryoablation, which is where you freeze the tissue rather than burn it away. Because workflow-wise, Farapulse is a lot more similar to cryoablation. But really, what we expected to see on our prior launch in Europe, what we are seeing in the U.S. is that people are adopting Farapulse irrespective of what they had traditionally been using.
And in fact, may have more advantages if you're coming away from using radiofrequency energy, which is burning the tissue away. And just because numerically, more people who do that, more people coming in from the radiofrequency world.
G ot it. As you mentioned, electrophysiologists are really enthusiastic about Europe for a while. They've been hearing from their European colleagues about how great it is, and demand is off the charts. What's the limiting factor for launch right now?
I honestly, the thing that is limiting the launch in the U.S., and I hate to use the term limiting, because it's not behaving like it's any governing factor on it. There is still issue with contracting, right? There is capital placement associated with the launch. The system includes a generator that generates the energy, as well as catheters and sheaths. Some hospitals capital process faster than others. Again, given the broad portfolio we have, there are things we can do to make that capital process easier for us. But I think that is probably the biggest that. We do believe, based on what I just told you, this is a premium product, and we are charging a premium price for it. But honestly, so far, we haven't seen that really be a barrier to adoption and launch.
Got it. What you said, this is a premium product, but at the same time, you're improving hospital workflows, and efficiencies by obviating the need in many cases to use mapping catheters. How do you think about that economic value to the hospital?
T his is still a very highly, very highly profitable procedure for hospitals. And what you just said is something that people are realizing. The reason why that premium price really hasn't been an obstacle. We're seeing the typical hospitals, once they've this technology, increase the number of procedures that they're able to perform in a given lab, in a given day, with 1-3 extra procedures. I was talking with one doctor here in the New York Metro area said that, you know, just in that brief period of time, also approved their ablation. We're also, besides the productivity is because the safety profile and efficacy is physicians are now treating younger patients, and they're treating the 80-year-old plus patient with multiple comorbidities that they were nervous about treating in the past due to some of the safety concerns.
It's actually in the ask for a mark, it's actually wide, further widening, which indicate .
Dr. Stein mentioned some data that you presented at HRS recently. There was a sub-analysis and an update from the global FARAPULSE registry. Can you just describe what are the key takeaways from those data?
A bsolutely. And also just come back to what Mike said earlier, right? The importance of supporting differentiated products with clinical evidence that substantiates that they really do meaningfully improve patient outcomes. We've now got approaching 70,000 patients treated clinically with Farapulse system. And we've published clinical data on almost 20,000 patients who've been treated with the system. We've published literally orders of magnitude more data with this system than any of our competitors. And the latest data, as you said, two releases, big breaking trials, Heart Rhythm Society. So one was this ADVENT analysis. ADVENT, again, for folks who don't follow us closely, was the trial that got us U.S. approval of Farapulse. The results were compelling enough. We got the approval from the FDA six months earlier than we had even anticipated.
So, randomized trial, comparing head-to-head Farapulse system with traditional thermal ablation. And what the sub-study showed is if you look at the actual amount of atrial fibrillation that people have after ablation, there's a cutoff point that's somewhere around spending 0.1% of your time in atrial fibrillation that is associated with worse outcomes for patients, a worse quality of life, more hospitalizations, more procedures. And what we found, again, in a very well-conducted, randomized trial, that Farapulse was superior to thermal ablation in keeping patients under that 0.1% burden of atrial fibrillation. As I said, it's the first time that anyone has demonstrated a pulse field ablation, superiority or efficacy. It's the first and only system that has any superiority evidence. The other data that came was from our Faradise registry.
That is a real-world post-market approval study, registry conducted in Europe and Asia. And in that study, over 1,000 patients, again, really pleased to see substantiated everything that we expected to see. You know, incredibly good safety performed. No permanent injury with the system, none of these complications that can occur with thermal energy, and a very low rate of any adverse effects.
Very good. At HRS, we also saw a couple of data sets from competitors on PFA technologies. As you said in the past, in the past, not all studies are conducted the same way. Points are constructed differently, monitoring is done differently. What were the key takeaways of jumping those competitive data?
I think there are two things I want to frame this up. You know, first is, as you say, right, no two clinical trials are the same. I always, you know, going back into professor mode now, from back when I was here in New York, right? You know, I always told the fellows, "Let's look at the headline." You know, you actually have to read the study, what they actually did. But that's also true about this field of pulse field ablation in general. It's really important to emphasize, right, that not all pulse field ablation technology is the same, that you can't generically.
The results you get with any type of system are just inherently linked to the design of the catheter, which governs the shape of the electrical field that you're treating the patient with, the waveform that you put through the catheter, how much energy and exactly how is it being delivered, and those are very closely guarded secrets, and the dosing strategy that you developed. And, you know, I think we want to be really clear, right, that no one take the high-quality data that we've got with Farapulse and assume that any of it can be applied to any of the competitive technologies. So those are all going to need to stand on their own.
The thing that I'd say is that our ADVENT trial is the single most rigorous definition of what constitutes success for ablation that anyone has ever used in a trial, and certainly a more stringent definition of success than any of the other trials that have been laid out.
G ood mapping. You've talked in the past about how legacy mapping systems are designed for thermal ablation. You expect to have a new Farapulse catheter approved in the H2 of this year that will be integrated with your arrhythmia mapping. What advantages do you think this new integrated system will bring? How do you expect the percentage of docs who do or don't use mapping with your pulse might evolve over time?
Again, right, to bring everyone in, you know, the ablation procedure involves a catheter like the Farapulse catheter. Many electrophysiologists, you know, strictly in the United States coupled that with what's called a 3D mapping system, where you can track catheters in 3D space beyond just looking at it as an X-ray image. We do have a next generation Farawave catheter, and this catheter can cause Farapulse that is designed to integrate with our mapping system, the arrhythmia mapping system. There are a whole bunch of really that we can do once we have a system that's designed from the ground up to understand pulsed field ablation. As we said, none of the existing systems, including ours, right, were pulsed field ablation in mind.
So we can do much better dynamic visualization of the catheter with the system. We can also do something we call field tagging. Because pulse field ablation is an electrical field phenomenon, right? If we know the shape of our catheter and we know the waveform, we can actually project onto the anatomy, here's where you're going to create a field. So, you know, here's where you're going to create the damage that you're trying to create before you actually do it. So you see, right, that everything you're doing is right, right, like, for any given patient. Really compelling advantage. Having said that, I think it's also really for us to say, we are never going to lock physicians in or send things our way. The key is to maintain this system. Physicians can do things better.
If you don't want to use a mapping system, you can use this without any mapping system at all. That's what we see predominantly being the use case in Europe. If you want to stick with one of your older legacy mapping systems, fine. I don't know why you'd want to do it, but do it now, right? With this next generation catheter, we'll be enabling you to do that as well.
Excellent. So let's see, maybe can you talk a little bit the pipeline upgrades, on the road that gets you excited? You've got a few trials underway to take the platform beyond the Farapulse catheter.
Y ou know what? We're pleased and proud of our portfolio as it stands today, but, but as Mike will tell you, we, we are never going to be complacent and just sit in place, all right? There are competitors, they're good companies. We need to maintain our lead. So there is a pipeline both of technology innovation and clinical evidence to support that technology innovation. We talked already about the next generation FARAPULSE catheter that's navigable and the upgrades, the RHYTHMIA system. Following that, I think the next important data release that we have is release of our trial called Advantage, which uses the existing FARAPULSE form to ablate what's called persistent atrial fibrillation, using a strategy of pulmonary vein ablation plus posterior wall ablation. Hopefully have those results out this year.
The second phase of that trial, we hope to have the results available next year, looks at our next technology product, which is called FARAPOINT, which is a point catheter that can also deliver the FARAPULSE energy, which can be used as an adjunct to the FARAWAVE catheter for certain lesions that may be required in an interventional procedure. Next after that, we're running a clinical trial called AVANT GUARD, and that's a trial looking at the FARAWAVE system as first line therapy for patients with persistent atrial fibrillation. That's never been proven before. Today, most patients undergo a trial drug therapy, they get referred to ablation. That trial began enrollment last December, expect to finish enrollment by the end of this year, then some follow-up period, have the results out follow.
And that's a trial that could materially expand population getting referred in for a fibrillation today. And then following that, new catheters in development, we have a large focal length catheter in development. We're exploring development of blind RF CFA catheter. Like to pull it out the chest. We got lots of,
Can you give us a rough magnitude of how Avant Guard expands the market? That's an exciting piece of the story.
I think, you know, potentially see two effects from a trial like Avant Guard, right? One is just pulling more ablation upstream.
Just a reminder of what it is.
I'm sorry. Again, so Avant Guard is the first line persistent atrial fibrillation ablation story. And even though, you know, it's just in time, it's pulling people in. But I think also it does pull in a lot of people who are not getting referred for the procedure at all today. Atrial fibrillation ablation today, again, in spite of the success that we've had, even with legacy catheters, it's dramatically under-penetrated as a procedure. I mean, you know, between persistent paroxysmal atrial fibrillation, we're talking low single digit—I'm sorry, low double digit, high single digit penetration, right? And so getting first line indication and consistent isolation, you know, can or ought to take up from that high single digit penetration and persistent AFib. You pick what it does.
G ot you. M aybe zooming out a little bit on all this, I think it's pretty clear that Farapulse is set up for a really strong launch over the next 18 months. I think some investors worry that market share that's gained so quickly might not be durable. You know, you talked about a few drivers and things you're working on going up against a really strong entrenched competitors here. How do you think about holding on to this business and grow it over the next 18 months?
I would say similar. We can't do this across all of our businesses, but we do there are certain areas where we really double and triple down in terms of portfolio enhancements and clinical science. And Watchman's certainly one of them, and I would say for most, clearly number one. So we have, we're really leading the way in terms of clinical data and new clinical trials and new indications, and we've got a very robust portfolio, along with, as well as a few venture bets in this area. And so it's just going extremely well, and we won't take our eye off the ball on expanding clinical and additional product answers.
Also, you know, our competitors are coming, but we've seen these competitors in Europe, and they are top competitors, so we're very, very confident in the first generation, product that we have versus what they're bringing in. So we think it may take multiple years for competitors to catch up in terms of productivity, efficiency, and efficacy that we see with Farapulse. Over that time period, we'll continue to enhance our platform, like I outlined.
Great. I touched on Watchman a little bit. Let's go there. Watchman hit $1.3 billion revenue in 2023, but the U.S. market is still only about 10% penetrated indicated patient population champion an option greatly expanding opportunity. You know, this is now established coding for a concomitant procedure, AF ablation with an atrial appendage closure. How do you think about the impact of that on the field?
Just a quick step back. Maybe people don't know this as well, and a lot of other companies use the same words now, but we talk about category leadership, the call points that we have. So most of our organic R&D investments and M&A are in areas where we have a similar call point, say, in this case, with an electrophysiologist. But we widen the portfolio across Europe, and so forth. So with this concomitant procedure you're talking about, we also acquired a company called Baylis a few years ago. Baylis is the market leader in providing access to the atrium for electrophysiologists.
So now with this category leadership strategy, if physicians are crossing this up and using the Baylis product, they're using clear pulse to treat their AFib, and now they have the opportunity to also complete the Watchman procedure, if they so choose. The option data will be written down to Q4-
Q4.
Q4 of this year, which would be shed some light on that. But so physicians will do a concomitant procedure, depending on the needs of the patient. Some physicians prefer to wait and do the ablation, then they can hold off and do the Watchman if they need to Watchman. But really what it does, is it provides Boston the best solution for, for physicians and for patients, for those patients who may need a concomitant procedure at the same time. And there's obviously dramatic healthcare economic benefits to the hospital, to the patients. Insurance, insurance companies like it. And so it's really... It's what the market needs, given the demand for Watchman and the demand for it. You combine those two together, what I get concerned about is capacity in cath labs.
That's, I think, the rate limiting factor, and so this will be an outlet for patients to receive both those procedures at the same time, with the economic backdrop that's supportive of the hospital and the insurance. So it's a nice win, and we're really uniquely positioned because of this investments that we've made over many years in that category leadership strategy by offering a leading LAC product, WATCHMAN, a leading pulse field product, and a leading access tool to actually get to where the physician wants to go.
Capacity in cath labs is definitely learning. How do you think about the growth of capacity there, to accommodate this big wave of procedure growth that's coming?
Well, one benefit that Ken talked about is just the productivity of the reversal of the productivity of the Watchman procedure continues to improve. With this new steerable sheath that we have, and you're seeing physicians, if they have a tough decision to make, do I do another mitral procedure or Watchman procedure? The lab is very comfortable doing the Watchman procedures, not dismissing the other ones, because the procedure times have come down so much, and the consistency is there because the tools that they have. Then you combine that with PFA, where you have hospitals improving efficiency quite dramatically, whether it be one patient a day or times 3 or 4 patients a day. So all of that helps in driving more productivity for the cath lab.
And then the concomitant procedure enables for the eligible patient, you know, further enhancements there. We'll continue to drive everything we can to reduce the procedure time, you know, with our portfolio.
So you're the dominant player with Watchman and left atrial appendage closure with, you know, dominant share there, way, way over 90%. But competition is obviously increasing, with Abbott, Amulet, Medtronic investing in the space, recently acquiring a unique approach to the problem. You know, how, how do you think about competition in this space and how the market might evolve over time?
I think it's actually very similar to the way we're treating Farapulse, which is, you know, don't just sit on one generation or product. Continue to improve the product, make it compelling for physicians, right? And so you've seen the evolution of our first-generation Watchman device to Watchman Flex, and now the Watchman FLX. You know, focus with that on doing the same thing with the Farapulse, make the procedure safer, make the procedure more efficient, make the procedure easier for physicians to do while maintaining efficacy that's at least prior generation. And we do have further enhancements to the platform coming up. As mentioned, our TruSteer team, with next-generation monitoring development. But it's also backing it up with clinical science, right? The OPTION trial and CHAMPION trial and trials of Watchman against bag of the drugs.
We're also engaged in another trial, trial four, which looks at very high-risk patients, combining Watchman with anticoagulation. You know, the belt extenders work better than just a belt or just extenders if you're at risk. And so it's never sitting back and resting our head, continued iterative tech-
Maybe simple way to feel about closure. It's like parents palette procedure, because you're not treating, you're preventing something catastrophic from happening down the road. It seems like safety is so key in a procedure like this, and it seems like that really offers an advantage to the incumbent. Is that the right way to think about it?
That's exactly the right way to think about it.
Great. All right, let's talk about TAVR. So, you know, U.S. approval for ACURATE neo2 got delayed and is no longer expected this year. Used to perform really well in Europe. Maybe you could just give us a little bit of a sense of, you know, how neo2 is doing in Europe and what you're seeing there.
Sure. The team's done a really nice job with that over many, many years now. And it's a valve that gets used every day in Europe. We have about 20% share in the accounts that we're in, probably 10% share of the market overall. But a big gap that we've had in Europe is the larger valve size, which is probably 25% of the market, and also hurts us choices every day because you want the whole spectrum of sizes. So we're really excited about a product called Prime, which we've submitted for approval in Europe, which fills in the gap in terms of that size matrix, allow us to compete more effectively and also offer some additional enhancements as well. But physicians in Europe really love to use the product.
The hemodynamics of the product are very low pacemaker rate, and it continues to grow faster, albeit off a lower lower share number. It continues to consistently, every quarter, grow faster than years in Europe. The U.S. trial has been fully enrolled, and we're looking for one-year follow-up data in the late here. And so we'll be providing data. We'll be providing information to investors and others in terms of when that data will be read out and what our plans are for U.S.
Got it. I think, you know, we heard a theory recently that, you know, perhaps one of the arms of the U.S. trial was stopped because physicians, neglected to do the post license step after the procedure. And I've heard some investors who are concerned about, you know, maybe there's a safety issue or something that caused the stop one arm. To that at all, I mean, is it, is it fair to assume that the strength of the performance in Europe should translate to the U.S. at some stage?
First of all, we didn't stop an arm of the trial. Like, the trial had finished its enrollment, was in follow-up. There was a pre-specified interim data analysis that, again, that we had early termination. We do need to wait and see the data set. We've continued enrollment, our extended durability portfolio. Again, you can read into that, I think, whatever you want. I think, again, we're nearly completed all of the trial. I don't think there's any point in speculating, and like I said, we'll see the data mid-year, and we'll know what we have. Again, back to that's that we've seen in performance, we've seen in Europe.
Last week at the EuroPCR, European Structural and Interventional Cardiology meeting, reported out the results of a very large real-world registry in Europe that showed operative performance with ACURATE neo2 compared to the XXL, compared to CPL 3. Right, so all the data we've seen in Europe supports that this is a good performing valve, and that it does have some differentiated advantages compared to other valves on the market, in particular other brand new valves.
Very good. We can't touch on all of the elements of the pipeline, but maybe let's hit Agent quickly. You know, you presented strong data at TCT last year for the Agent IDE trial. Agent got FDA approved in March to become the first drug-coated balloon in the U.S., treating in-stent restenosis. Feedback you're hearing, you know, so far on the U.S. limited launch?
It's very early into the launch. There's certainly nothing that we haven't anticipated. Again, very excited about the product. It's the first and only drug-coated balloon approved for use in the United States. Approved for in-stent restenosis, and for the folks who is familiar with this, that's about 10% of all coronary interventions in the United States today. And as we look towards other potential uses of that device beyond in-stent restenosis bifurcation regions, small vessel disease, you know, that, to 1 in 5 interventional procedures, in the U.S.
V ery good. Okay, maybe we'll just touch on TheraSphere quickly. You know, there are some real interesting expansion opportunities related to geography, combination therapy. Can you just touch on where you are with TheraSphere as an acquisition you did a few years ago and really invested in a lot of work there? What's the status of that business?
Similar to our profile across many of our divisions, again, it was focused on category leadership. So within our interventional oncology business, which is the fastest growing segment, within our PI division, we have a wide portfolio and the most comprehensive portfolio, similar to what we talked about with Afib and Watchman and some other areas.
With our cryo product, with a multiple embolic tools that the interventional radiologist would use in consultation with oncology, as well as therosphere, which is the one of the gems within that portfolio. And so therosphere is radioactive beads that primarily targets liver cancer, and we're the market share leader there, and it's a business that grows faster and WAMGR faster than our Boston Scientific average. But we continue to, just like we do in many areas, look to widen the patient indication. And so we have trials going on right now for glioblastoma as well as prostate, that are early feasibility early safety trials, so it'll be a multi-year process.
We have some interesting trials going on in China, where the market's quite a bit larger than the rest of the world for liver cancer. So we're expected to enroll that trial, I think, by the end of 2025, ish. Maybe before, but I think that's about right. And so we're trying to get approval in China, and we're also doing a number of trials, is it the Rowan trial?
The Rowan trial as well. Maybe touch on that one.
If you have it, if you can, if not, we'll move on.
No. So just, you know, a little bit more color, right? Again, so primary liver cancer is one of the most common cancers in Asia, East Asia in general, China in particular.
You know, we can look at the use of TheraSphere, either as a primary treatment modality, but also using it in combination with immunotherapy. So that's the Rowan trial. Again, as Mike said, also looking to indication expansion for TheraSphere, both in primary brain cancers, glioblastoma, prostate cancer. Just to come back, again, TheraSphere is a lot like a lot of our other products, right? The goal here is to give really targeted dose of radiation therapy, you know, only to where the tumor is, and so avoid bystander injury. I mean, mechanism is completely different from Farapulse, but it's a lot like Farapulse, right? When you think of the philosophy, again, it's how do we make procedure safer for patients, avoid unintended injury?
How do we do it in a way that's straightforward and relatively simple to apply? So these are the symbolic glass beads, and how do we have something that actually works for cancer patients?
Got it. Let me just touch quickly on neuromodulation. This is one of the businesses that's grown a little bit more slowly. It's actually declined 1% in the Q1. Spinal cord stim is one of those businesses that's been impacted by COVID quite a bit. You've done some acquisitions here, Vertiflex, which maybe hasn't quite lived up to expectations, but then ReLEEV, where there's a lot of excitement. How do you think about just the overall outlook for the neuromodulation business?
So overall, neuromod will likely be dilutive to the overall growth rate of the company, but we anticipate it'll be better, improving versus what you saw in Q1. And the overall neuromod business is broken out into a couple segments. One is our deep brain stimulation business, which is growing in line or accretive to Boston Scientific, typically. And the business that's been under more pressure, as you said, is the spinal cord stimulation market. Maybe the one of the slower growth markets that we're in across the portfolio, and part of it is COVID, but part of it is, you know, physicians having less invasive choices. And so we're trying to go after the full pain continuum, and so we have made acquisitions with Vertiflex.
Our radiofrequency business is doing quite well, and ReLEEV, which I think goes organic in Q4 this year, is doing extremely well. And so, those are faster growth markets, although the spinal cord stim is a bigger market, dollar-wise. But that combination of, again, is the category leadership strategy, is we wanna provide the most comprehensive pain solution, for those physicians. And we aim to get better in our core SCS business. We've made some changes to our internal capabilities on commercial teams and so forth. We've had some recent approvals for virgin back, and DPN, and so we aim to get better. But overall, I think the business can deliver on its LRP that we talked about at the Investor Day.
Very good. Zooming out a little bit, you know, we've touched on a lot of M&A during the conversation. You talked about being an angel investor very early in Farapulse. You have an active VC portfolio. H ow do you think about that as a competitive advantage for Boston Scientific? I think a lot of companies would love to snap their fingers and be able to be really good and effective at, at M&A. You know, what, what is it about Boston Scientific that makes you so effective in that area?
I think we're pretty good. We can always get better. I think the, we've put a lot of time into it. I would say we've put a lot of time into it, and we have good processes that allow for appropriate fast decision-making. Most importantly, we have excellent teammates across the world and in the divisions who are always looking for new innovation. And we do whether it's our VC portfolio.
Typically, we're looking at acquisitions typically in more white space areas, not all of them work, that would be sponsored by that business unit. So we don't have a venture portfolio that's just trying to make money only. So we're looking. We obviously wanna make money on it, but they're typically investments that we have an aim to acquire for to further enhance the innovation cycle of that particular business unit. And we have about 40 or so venture investments that we continue to look at.
We're excited about that portfolio, and we'll continue on our high-quality M&A track record that we've had.
Very good. I mean, just thinking about the other side of the coin, you know, Boston Scientific is a really nice size right now. It's $14 billion revenue. You've got a bunch of growth drivers that can move the needle for you. When companies get too big, sometimes they get a little bit more difficult to manage. You know, how do you think about this? Is there a Goldilocks zone for Boston Scientific, and would you consider pruning businesses at some stage to keep the business at?
Sure, we always look at pruning. We prune within our divisions, our portfolio every year, just to rationalize the portfolio, to make it more manageable, to... So our operations team can focus on value improvements. We always look at larger, you know, do divestitures make sense? But, the whole key is how you're organized operationally in terms of running it and the quality of your global team. And we have very empowered leaders across the world. We break our business downs, business units into subsegments, and people lead those businesses, and they're incentivized and expected to grow faster than their peer group and grow margins faster than the sales.
So I don't think the company is any harder to run now than it was eight years ago, except now we have so many more tailwinds with the fast-growing markets because the markets that we're in are in a very strong portfolio. But we have very deep bench across our teams. They're very competitive, and so I don't see, you know, our current size and as we grow through LRP, in a significant change to how we lead and run the company.
Excellent. Well, I'd love to touch on every single one of the businesses, but unfortunately, we're gonna have to leave it there. Mike, Mike and Ken, thanks so much for, for being here. I really appreciate it.
Thank you. Appreciate it.
Thanks for having us.
Thanks so much.
That was great. Thanks.