Thank you so much for hosting us. Maybe I'll start and just say thank you for acknowledging our Great Investor Day. We thought it was a great day as well. I think our goal of that day was to leave you with not only the excitement around what we have in hand at Boston Scientific today with growth drivers like FARAPULSE, Watchman, and others, but really a view on the future. That is why we have Janar here today to talk a little bit more about some of those big adjacent markets that we want to enter into. That is all with underlying strong market growth in the procedures we treat and the relentless focus on innovation to continue to bring more value to our products, our procedures, and our patients.
Excellent. That just leads us straight into electrophysiology. You have a few things going on in that area. Would you like to give us a state of the union?
Sure. The EP business, which has really had a tremendous run since our first introduction of FARAPULSE into the EU market back in 2021. And as you know, we entered the US market in 2024 and then Japan and China subsequently. We are growing, as you've seen in our numbers today, probably 2X the market, driven by the ecosystem that is everything around FARAPULSE. That is the FARAWAVE catheter, the approvals we've gotten for both PVI and PVI posterior wall, set another way, both paroxysmal and persistent indications, as well as the integration of FARAWAVE into our Opal mapping system, which we commonly refer to as FARANAV. There's a bigger ecosystem that I'm sure we'll get into. For example, if you look at PFA cases around the globe, it's not uncommon.
With a physician, are you selling all three? Are they using all three? I mean, I like the painting analogy here, but how do you think about that?
Today, up until whatever it was yesterday, most of our conversations with physicians around the world were Farrowave on the Opal mapping system. That's the ecosystem that has driven our success, really, in every market around the globe. Now we will add to that, starting immediately in Europe. Hopefully, in the short term, we'll get FARAPOINT approved in the United States. That expands our ecosystem, which, again, the ecosystem to date has been largely use Farrowave to do your index PVI, PVI plus something else. This will add the ability not to pull an RF catheter, as an example. You'll be able to go to PFA for point. All of that is optimized in the Opal mapping ecosystem.
At the analyst meeting, I think you spoke about 80% worldwide transition to PFA at the end of your LRP. With this type of portfolio, why 80% and why is it going to take to 2028?
I think it has to do with when did markets start, really? If I had to pinpoint one answer, it's in Europe, it's hard to talk about Europe as a single market. It's 15 different markets that matter. Let me focus on the U.S. The U.S., as we said at investor day, very quickly went to greater than 50% penetration. That's largely due to this broad applicability, replicatability of the Farrowave workflow. If I look at Japan or I look at China, when did they get approved and where are they on that journey? Now we're almost two years into the U.S. journey. We're four years into the European journey. I think the rate and pace of penetration is closely tied to what technologies you have approved and what indications you have approved.
Now with the approval of persistent AF in the United States and other markets, that will juice further penetration, as will other products getting approved in the ecosystem that we call FARAPULSE.
Right now, most of the, all, it's not just most of the applications are on atrial fibrillation. There was a little teaser at the analyst meeting about diabetes. Having been a student of med tech for a very long time, you never take technology into just one area of the human body. I've never seen radiofrequency in a narrow space. How do you think about ultimately taking pulsed field ablation into other applications?
I'll say, first of all, we're maniacally focused on expanding it in the $13 billion EP market.
That little market.
Yeah. That's $9 billion of AF and $4 billion of other things. We spend the vast majority of our time on that and achieving category leadership in that space. I think we talked a little bit about some venture capital investments that we've made, for instance, in the diabetes type 2 indication. We don't really give a lot of details about those. Suffice it to say, we're looking at PFA applications in other places. What dominates our thinking right now is how do we extend our leadership with our FARAPULSE ecosystem in EP.
From in EP, we'll stick with that for now. How do you think about the changing competitive landscape? There will be a new market participant in the United States next year.
Yeah. I mean, surprise, surprise, everything in cardiology has multiple competitors, and it's highly competitive. That's been that same way for the 35 years I've been in cardio. That's kind of par for the course. We have the good news in a PMA-driven market is you tend not to get surprised. You can see what's happening in the CE Mark trials. You can see what's happening in IDE approval studies in the U.S. Suffice it to say, I think we have a very good understanding of what competition we'll face and in what time frame. You can't do much about that other than make sure that our ecosystem, the three catheters that you talked about, the Opal mapping system, the Opal mapping capacity, those are the things directly in our control that we remain super focused on.
Is there anything about what happened in Europe with competitive introduction that you can say, this is what we learned from there, and then this is how we anticipate it in the U.S.?
You know, I think what we've learned, I spoke about earlier, and that is the uniqueness of the Farrowave flower and basket combination and its applicability to PVI, ablating pulmonary veins and doing other work like posterior wall is, I think, completely unique to Farrowave as a workhorse tool. What we learned is other entrants aren't quite that extendable, replicatable in all of those use indications.
Okay. When we think about the next wave of technology, in my investor conversations, we're spending more time on Watchman. Not that this is new, but that there is some data coming out next year that people might be focused on. How do you think about the Watchman franchise growing over the years, accelerating with OPTION and then what CHAMPION may or may not help out with?
Yeah. I think we've been very consistent in saying our long-term view of Watchman as a 20+% growth engine for BSC depends on both OPTION and CHAMPION being positive. Obviously, OPTION this time last year was presented and published in the New England Journal of Medicine. We've said that CHAMPION, which I should probably describe CHAMPION for a second because it is different than OPTION. OPTION was a trial where we said, let's randomize. All patients get an ablation. Half of them stay on anticoagulants. Half of them get a Watchman placed. Let's see what the clinical outcomes are there. CHAMPION does not require ablation. It takes frontline randomization, NOAC-eligible patients. Half of them stay on NOACs. Half of them are implanted with Watchman.
That trial, which is 3,000 patients, three years of follow-up, the first big, large, statistically powered head-to-head trial for first-line indication, that's the CHAMPION study. It will be presented. We haven't been super specific. First half of 2026, that should read out.
Once it is read out, assuming it is positive, what are the steps to it being implemented?
Yeah. The first thing is we have to get our label updated because today you could say, whether you look, and I won't go through all the gory details, we are not labeled for first-line therapy in most markets. There is the difference between what does our approved label say and what does reimbursement look like. That is different all around the world. The first thing we'll do is we'll go to update the label. If you look at OPTION, as soon as we got that data, we began updating the label. It took us eight-ish months to get the label to include concomitant ablation. We'll first work on label. We will also work on the guidelines. The societal cardiology guidelines around the world, we'll work with those groups to get the guidelines changed.
We will go after reimbursement in all the major markets around the world. For instance, in the United States, there's a national coverage decision that indicates and dictates how and when Watchman is reimbursed. We'll take a label update, guideline update, and then, again, with positive CHAMPION data, we'll negotiate with CMS to open the NCD to expand the indicated patient population. I'll shorten this answer. What we said multiple times is we believe that the CHAMPION indication expands the population eligible for Watchman to approximately 20 million patients around the globe. I think that's three or four times bigger than our current. That drives the reimbursement, the label, et cetera, drives nearly a tripling of the Watchman TAM to $6 billion by 2030.
What we've seen in other data presentations is once it's out there, doctors start to change their practice even before you go through the label and the reimbursement and everything else. Can we expect the same thing here?
I think so. I think people do pay attention to late breakers. It begins to change practice long before some of that happens. I think we've been pretty clear that label, guidelines, reimbursement, that doesn't happen overnight. That's why we've been pretty focused on what does the Watchman, the LAAC market opportunity look like at 2030? I don't think I'm surprising anybody this. Guidelines don't happen overnight.
I've heard that.
Right. Yeah, you've heard that before.
I've heard that. Very good. Janar, thank you so much for joining us. I don't feel like you have had as much sunshine on the Boston Scientific platform yet.
Okay. No problem.
It's okay. I think maybe if you could share with us the products which are under your umbrella because I think those are some of the ones that are really the drivers that came out of the analyst meeting.
Yeah. I mean, I think if you look at how we view interventional cardiology at Boston Scientific, we basically try and cover every product that an interventional cardiologist may have some involvement with. We share some of that leadership with the Watchman franchise as well. The things that we obviously cover that have been core to us for several decades is coronary therapies. Within that, we're very excited about intravascular lithotripsy that is currently enrolling in a trial at the moment with a Seismic device. Of course, everyone's aware that we recently acquired an RDN device, renal denervation. That also falls under our purview as well. We're also in the process of getting soon to start a trial next year using an LV support device, which is an in-house developed product called Vitalist, which is a pump.
We essentially cover the broad spectrum of what an interventional cardiologist does, which, as you know, if you give us a wire and a balloon, we'll take it anywhere.
I like that approach. Let's start first with the Seismic device for IVL. Can you remind us of how you think about that clinical trial, the market opportunity, and being a disruptor in that space?
Yeah. Maybe I'll start with the market opportunity first because that's how we've approached the device and the product and where we see IVL fitting in. When we met at investor day, we talked about where we view IVL. We have been very, very maniacal, and Joe talked about surrounding the EP with an ecosystem. It's no different for us in interventional cardiology. In coronary therapies, interventionalists want a toolbox. They want a lot of different tools, imaging, different options to treat. Prep of the lesion is very key to that. We structure our portfolio and our investments and how we educate with a moniker of see, prep and treat. Within the prep box, we focus IVL as being one of the three tools that we will have, hopefully, for calcium, which is cutting balloon, rotational atherectomy, and IVL.
Seismic is a tool that we're very familiar with. It's a product that was developed internally at Boston Scientific, and it's a reflection of our investment and innovation in that space. The catheter has some unique features in that it's got two sets of emitters at either side of a balloon. There are four emitters at each of those points. It allows circumferential delivery of energy. The energy is delivered using laser. Think of it a little bit like an earthquake. It creates a little explosion in the balloon, and the waves are what go out and crack that calcium. The reason that's so important is that if you look at our practice and therapy in the cath lab that's changed, our patients are getting more and more complex.
What is the enemy of the interventionalist in the cath lab is calcium, which at least roughly about a third of patients that come to the cath lab have calcified coronary artery disease. That number is only going to increase as our patients are getting older with more comorbidities, more renal failure. We see that as being a very important toolbox to have. The product also has some other differentiating factors in that it's got very visible emitters. You can see it very easily. Deliverability so far has been very promising. We also have seen some early promising signs about efficacy of the product, which of course is important to physicians.
What is the timeline to bring it to market and for us to see the clinical data?
Yeah. We're currently enrolling in the Fracture ID study that's well into enrollment. We anticipate completion of that in Q1 of 2026. We're looking at a commercial launch in the coronary use of the product in the first half of 2027.
When will we see the data?
It'll be next year.
Next year.
Yeah.
First half of 2026, first half of 2027?
We haven't made a decision yet as to which meeting it'll be, but you'll see the data in 2026, the 30-day endpoint.
Very good. That brings us to some of the products that you're working on also in renal denervation. That came through an acquisition.
Correct.
What made that the right acquisition at this time? Also, I'm going to add to that, I have a memory of Boston Scientific having a renal denervation program way, way long ago. Why is this the right technology at this time?
Yeah. If you look at the history of renal denervation, as you know, it's not been a straightforward road. It's been an incredibly bumpy road for anyone involved in the space. We similarly evaluate different spaces all the time, and our viewpoint changes with regards to it. The clinical data has evolved over time and become much more promising. This particular asset has been part of our VC portfolio. We like to take investments and bets in innovation. The reason we came back to this is that hypertension is incredibly common in our community. One in four adult Americans have hypertension. For anyone that's tried to lose weight with lifestyle medications, and I mean, put your hand up if you've ever completed a course of antibiotics. I certainly haven't. Medical therapy is challenging for a lot of patients in terms of compliance.
Having a device-based therapy provides another option. It is an opportunity to treat quite a lot of patients, which is why we went back to it. This particular technology is ultrasound-based in terms of its energy. We feel pretty compelled that that is a pretty efficacious way in order to denervate the arteries compared to radiofrequency. One of the reasons we like the product as well is the ease of use. It is an incredibly simple device to use. I mean, we chatted about it at investor days. It is probably one of the few products in interventional cardiology that has one moving part. There is nothing to really do with it. It is a single device that can be used for all patients. You do not have to size the vessel. Ease of use is also another thing that really attracted us about this particular asset.
Why is ultrasound better than RF at this stage?
Yeah. I think for a couple of things in that with this particular technology, ultrasound has the potential to have a greater depth of penetration. I mean, if you look at radiofrequency ablation, you made the comment, we take these technologies in different spaces. Radiofrequency ablation needs to have some particular planning and application of where you deliver the energy. You have to be very precise about it, no matter whether it's in the renal artery or somewhere else in the body. The benefit of this is that there's less operator-specific use for it. You just place it, and the ultrasound is circumferential. It is less operator-specific in terms of technique, and that helps you in terms of ease of use as well.
Is there anything in the CMS reimbursement guidelines which came out recently that you're like, "Yes, that works for us," or anything that caused you pause as we relate to renal denervation?
Yeah. I think the recent NCD recommendations were similar to what they had kind of proposed earlier on. There wasn't necessarily a big surprise to what they had shared earlier. Just to look at what they had shown with patients with uncontrolled hypertension, they need to have a single physician that sees them over three different visits over a six-month period. You have to fail very similar to other therapies, which is you have to fail lifestyle intervention, medical therapy, and then you become eligible. It's a fairly standard process for routine care. I think what we'll have to see is how this impacts access in terms of the center availability. In terms of the patient journey, it's very similar.
We were very reassured that there were also virtual options for visits put in there because trying to see a physician sometimes in person can be tough for patients.
One of the things which comes up, and this is going to impact both of our conversations, is having enough access, enough access to a cath lab, enough access to mappers. How do you think about these as hurdles for both of your franchises in terms of utilization and moving things forward?
I think they're radically different. I'll let Janar comment on the hypertension capacity question. EP, if you look around the world, every market is dominated by very large teams of mappers in electrophysiology and a very large footprint of mapping systems. We get asked the question a lot, like, "What is BSC doing?" I think it would be fair to say a few years ago, we didn't have a whole bunch of mapping capacity, and we didn't have a bunch of install. The good news for us, as soon as we kind of knew that the U.S. approval was imminent, we began with a very strategic and tactical program to significantly expand our mapping capability and capacity. What does that mean? Think of that as hiring multitudes of hundreds of mappers beginning in late 2023.
If you look today where we are 24 months later, we don't give specific numbers, but we have dramatically increased that capacity, both people and systems, to have the Opal FARAPULSE ecosystem available to accounts all over the world. I'm sure we'll get asked, and I don't know if we said it before, but compared to where we were, which wasn't that great, two years later, we have significantly expanded both the capacity and capability of our FARAPULSE Opal ecosystem.
Yeah. I think when you think about hypertension, coming back to that about the long journey of RDN, I think the way that we view that particular market is before we start thinking about access, which of course will become an issue to address. I think before that is also just making physicians and patients aware of the therapy. There's going to be a significant amount of therapy development that will be needed for that space, very similar to the journey that we went on as a company with Watchman, educating patients about the options. We view that space as being a very similar kind of thing that we will need to do and contribute to the space, which is educating both the referrers, but also the patients themselves about the therapy. The capacity side of things, this is, again, another reason we like this particular asset.
It's not a complicated procedure to do. The infrastructure and ecosystem of the device itself is very small in terms of footprint. The equipment and workflow needed is very similar to any cath lab. Any interventionalist can learn this and do this in a standard cath lab setup. There's not a lot of accessory equipment needed. It fits into the regular workflow very easily as a procedure.
Both of your procedure buckets, and I'm speaking big picture here, are mostly hospital-based, but we keep seeing more and more moving into the ASC, including the opportunity for PFA being moved into the ASC. How do you think about that trend or flow over the next few years?
It's very clear, and I think CMS reiterated this in the latest outpatient, that their goal is to take all of the inpatient-only procedures and move them to outpatient. Stated goal of CMS, we applaud that, and we have to prepare for that. With that, you have big markets, big procedural base, like all PCI and all ablations have now been approved to move to the ambulatory surgery center site of service. We have to think about the ecosystem that we sell into that environment versus an inpatient-only. I really applaud our teams because that's probably going to look a little bit different when you think about ablation procedures than what the physician, what the site gets to use in an inpatient-only.
Deeply embedded in our strategy is if that ecosystem of products and what's wrapped around the procedure is different, we have to be prepared for that. And I, for one in the EP space, feel very confident that we've got a very broad spectrum of things that we can sell into each of those inpatient, outpatient, and ASC environments and contend for leadership.
Maybe just to add a little bit on the logistics of moving to the ASC for ablations. There are roughly five states today that have a cardiovascular ASC and are unencumbered by a certificate of need. Therefore, you're likely to see some movement sooner there. Broadly speaking, this will take time and won't be necessarily an overnight. As Joe said, we see Boston Scientific's portfolio of products as being uniquely suited to do really well in that ASC space. We've been preparing for that. Excellent. Cardiac rhythm management is a space that I felt like I stopped talking about for years, and suddenly I'm talking about it again. At Boston Scientific, how do you think about the newer products which are being introduced and some of the market share shifting and growth dynamics of the subsector or the subdivision?
Yeah. If I think about the CRM global market, it's admittedly the lowest growth market that we compete in in cardiovascular. However, I think it's also fair to say that we have fallen behind that market growth. That's largely due to our product portfolio. If you look at the big categories that have driven the CRM market growth, two of them are conduction system pacing and leadless. Conduction system pacing, the good news for us is most of our conduction system pacing portfolio now is approved in the United States and most recently got approved in Europe. That's a gap that we are in the process of filling. If you look at leadless, which are both EMPOWER and modular systems, those are in at review at FDA. We don't have approval today, but that will allow us to create an offense in leadless.
The other thing that we talked about on the call, I think the Q3 call, is, and I'll try to make a very complex project very simple and short. For us, about once every 20 years, we have to do a complete revamp of our CRM portfolio. The last time we did that was in 2006, 2007, 2008, where we launched COGNIS and TELIGEN. That was a complete reboot of our CRM portfolio. We started that program about five or six years ago. I think Mike referenced it as Denali. That's just the internal name. That's not the product name. We are now in the very late innings of finishing that next-gen CRM total reboot. Think about every active implantable cardiac rhythm management device that we sell. Everything from pacers to CRT-D is in a complete refresh.
While you're doing that, you probably starve the business a little bit for some of those things that you'd like to deliver to the market, deliver to your sales team. The good news is we're in the very late innings of finishing that program. I think when you look at the long-range plan that we talked about in September, you saw us committing to at or above market growth. A big part of that is the fact that we will have that once every 20 years CRM platform delivered in the long-range plan. We just filled, as I said earlier, the conduction system pacing gaps. We're on the cusp of getting our leadless EMPOWER platform approved.
Excellent. I was surprised, might be the right word, at, and let's say, back into structural heart, back into not the Watchman side of structural heart, but the TAVR Mitral Tricuspid side of structural heart. I guess that goes into the topic of there's more to come, maybe. I'm not sure how to interpret that.
Yeah. That was the VC investment in TAVR, mitral, and tricuspid. Nothing specific, but I would say in general, we've said we have some history with TAVR, to say the least. If we were to get back into TAVR, it would have to be a highly differentiated product that would allow us an opportunity to be more of a leader than a follower. We have a lot of different opportunities across the portfolio to invest in. That might be an area of interest for the company.
The analogy I draw is there's no way our interventional cardiology, broad coronary therapy, structural heart. There's no time on earth where we're going to ignore an $8 billion-$10 billion segment like structural heart. At the other end of that spectrum, I'll give you an example. If you look at our electrophysiology business, there's a segment within the $13 billion market that is imaging, basically 2D ICE and 4D ICE. That's probably a plus $1 billion segment that we have not been in, but we've recently introduced three or four ways that we're going to get into that market. That's a good example of where we relentlessly pursue category leadership.
There's no way our EP business gets a pass and says, "Oh, imaging, billion whatever, billion three, we're really not interested in that." If it's a big component of the procedure and the ecosystem that the physician uses, we are focused on that. You'll see the CHORUS introduction, second half, that's our 2D ICE. You just saw our 4D ICE partnership with Siemens. We've been public about our AI partnership with Anumana to take to another level the ability of things like 2D ICE or TEE to help support both structural and EP procedures. That's a really here and now example where we've been very public about those three or four things that we have planned to enter and disrupt the billion plus imaging market in the EP structural space.
There you go. I think we have time for one or two more questions, but I'm going to actually pivot slightly to artificial intelligence and how you think about applying it into the organization product development. Is it something that becomes a revenue stream, a product, or just something that makes it easier to get through approvals?
I think because we already have approval for it, Janar, why don't you talk about imaging and how we're using AI there, and then I'll talk about EP.
Thanks.
Yeah. I mean, within our franchise for interventional cardiology, when you look at our portfolio, we launched our next generation IVA system of AVVIGO+, and that has artificial intelligence integrated through it. Think of it a little bit like your iPhone. You get a software update every couple of years. That's our intent with this device and this product is that the artificial intelligence component of the imaging system makes image interpretation easier for the physician. Each time, every few years, they'll get a new update where the assessment of the lesion, vessel sizing, stent placement, all becomes quicker, easier, and more efficient for them in the lab. Artificial intelligence is something we're highly focused on as a company. The other way is internally in terms of improving efficiency within our teams. It's a tremendous opportunity for any industry.
We're looking at it not just within our product portfolio, which is key, but also just within how we run teams and trials and even just efficiencies across our workforce.
Yeah. On the EP side, you'll see in 2026, AI applied to transesophageal echo to support the Watchman procedure. Later on, after we get CHORUS approved, which is our 2D ICE, 2027 and beyond, you'll see AI doing image interpolation, image creation to facilitate ablations. Those will be our first two moves.
Excellent.
Using AI.
My favorite question as I always close out, when we're together here next year, what do you think we're going to be talking about?
What I hope we continue to talk about far, far into the future is how well the category leadership strategy at Boston Scientific plays. It does not matter if it's neuromod, uro, EP, interventional, endo, our game plan of committing to category leadership. That goes beyond, "Oh, we just want to be a leader in endoscopy." No, we want to be a leader in any major category that defines the endoscopy space. What the heck am I doing talking about endoscopy? It is the example because under Mike's leadership, our category leadership, which drives our tactical go-to-market commercial strategy, it drives our internal R&D innovation machine, and it also drives our extensive investment in innovation through VC bets, early ownership interest in technology. We think that's really driven our success over the last 10 plus years.
There is no intention to change that when you look at the next 10 years because why? It works. We think it works.
Janar?
I think we gave a little teaser of this at Investor Day. Obviously, being a clinician, I'm biased, but I think we chatted about this earlier. I think next year, we'll be talking a lot about clinical trials. You're seeing that major trials like CHAMPION or anything that's a late breaker really has a tremendous opportunity to change practice, change markets, change how patients are treated. We, as a company, whether you look at any aspect of our divisions, we're investing a lot in science, in interventional cardiology or EP, whatever you look at it. We have a number of trials coming out next year, the few years after that. I think we'll be spending a lot of time talking about that next year.
Wonderful. Joe, Janar, Lauren, thank you so much. Thank you for joining us here. I hope you have a great day.
Thanks, Janar.
You too. Thanks, Joan.