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2026.09.28 | TB | MedTech | Pulsed Field Ablation Throughput

原标题：Pulsed Field Ablation – Health System Throughput & Dual-energy Ablation Technology

#medtech

Third Bridge · 2026-09-28

Analyst-led • 14 Sep 2026

Companies: ABT US, BSX US, MDT US, JNJ US

Edward Chu (EC) Cardiac Electrophysiologist at Miami Cardiac & Vascular Institute

George Congdon (GC) — Third Bridge Sector Analyst

Agenda

Key Insights

Introduction

GC [00:00:01]: Welcome to Third Bridge's Interview entitled Pulsed Field Ablation – Health System Throughput & Dual-energy Ablation Technology. I'm George Congdon. I'll be facilitating today's Interview with Dr Edward Chu, a cardiac electrophysiologist at My Cardiologist.

Dr Chu, before we start today's Interview, please state I agree or I disagree to the following statement: You understand the definition of material non-public information and agree not to disclose any such information, or any other information which is confidential, during this Interview.

EC [00:00:37]: I agree.

GC [00:00:39]: Could you begin with a little bit of an introduction to your background?

EC [00:00:45]: Sure. I've been a clinical electrophysiologist for over five years now. I work in an urban environment. I work in Miami. I also see patients up in Boca and Delray, so just the South Florida area. I am largely a procedural electrophysiologist, meaning I prioritise more of my time to doing procedures and a lot of those procedures focus on the treatment of atrial fibrillation with ablation with PFA as well as left atrial appendage occlusion being the two most common procedures that I do overall and definitely for patients with AFib or atrial fibrillation. I work in a private practice group that has become private equity. I go to about half a dozen different hospitals or so in this geographic South Florida area. We are also in the process of operationalising an ambulatory surgical centre, or an ASC, as I'll refer to it throughout this conversation. Definitely getting involved in the forefront of operationalising AFib care in a different setting.

Questions

[00:02:01] What's your approximate monthly case volume and mix across paroxysmal, persistent and redo AFib [atrial fibrillation] patients? Moreover, what is your current device split across Farapulse, Affera and Volt, as well as the mapping systems?

EC [00:02:30]: A lot of questions in that one ask. What I will say is, I can give you a big-picture view. Over the last five years, my ablation volumes on an annual basis have increased. For me, most recently, in 2025/6, I'm doing about 225-plus AFib and AFib-related ablation procedures. These are all with PFA. My left atrial appendage occlusion volume is 100 or more, and that's increasing over the last five years as well. If you ask my month-to-month, it's probably not a really fair indicator of things because here in South Florida, as many of you know, we have snowbirds that are gone during these summer months, and they're back soon. My summer months, in the last several months, have been slower than my non-summer months, but that's just the nature of the population changes with snowbirds in South Florida and Miami. That said, again, I think if you're comparing MoM from YoY, my AFib ablation volumes are increasing slowly but steadily. I think that's just a reflection of the number of patients that are both being diagnosed with AFib as well as the guidelines in the treatment of AFib favouring ablation more and more, especially in the younger patients and as well as those who have bad symptoms.

My vendor mix over time has changed, and that's owing to a number of things. The biggest one is that as of right now, there are only four FDA-approved PFA vendors, that's Biosense, who I don't use at all, Medtronic, Abbott, and Boston Scientific, and the latter three I do use. Abbott Volt only came about or it was only FDA-approved within this past year, several months ago, and that's not even rolled out across the country, just mostly in select markets like Miami and other bigger cities. I will say that my current mix of vendors is probably 60-70% Boston Scientific with Farapulse, maybe 15-20% Abbott with Volt. Again, that's a newer option for me. Then the remainder is with Medtronic Affera. One year ago, it was probably closer to like 80-90% Boston Scientific Farapulse and the remainder was Medtronic Affera. Again, that was mostly because Volt wasn't in the market yet.

[00:05:23] How has your volume and platform mix trended over the course of 2026 as newer platforms have come online, considering some of the demographic differences in the South Florida area? You mentioned that it's variable in the summer and winter as people go back to other locales.

EC [00:06:16]: That's a great question. The bigger shift is towards Abbott, Volt, which just got FDA-approved maybe several months ago and it is probably not fully commercially available across the country because of the way they roll out things. They have to prioritise markets where they have more market share. I've definitely done a lot more Volt. It went from zero to whatever my percentage is now, about 15-20%. That's come at the expense of Boston Scientific. I think part of my interest in using Volt is that it's obviously a newer technology. That doesn't mean it's better. It's just newer. There's a novelty around it. Abbott has been drumming up the promotion of this new Volt system. It doesn't mean that it's actually that great, but they do a great job at marketing, and we're very familiar with Abbott ablation and mapping products, so we were excited to test it out. I think it's come at the detriment of Boston Scientific because they were a market leader. They've been around for a while. They haven't really innovated much from their Farapulse days. In my mind, it seems like they're just trying to squeeze out the most they can before having to be forced to innovate.

For me, the flip side of novelty is that there's really not much novelty left in the Farapulse system. I am comfortable using it. I'm very familiar with it. I know what it can do and what it can't do. I think for that reason, Volt, which is a single-shot technology, so to say, has eaten away at Farapulse, which is an analogous single-shot PFA technology.

[00:08:14] In our pre-Interview conversation, you mentioned that platform selection usually comes down to whether the case is paroxysmal, persistent or a redo. Could you elaborate on that decision matrix? For a given de novo paroxysmal pulmonary vein isolation vs a persistent case requiring posterior wall or anterior work vs a redo ablation, which platform do you go with and why?

EC [00:08:38]: That's a great question. I've been thinking about this distinction. In the world of AFib, you can cut the AFib categorisation in different ways. One way is paroxysmal vs persistent, which I don't think is a really good distinction or dichotomy when it's being applied to how we think about which ablation technology to use. In my mind, the better distinction is, has this patient been ablated before? Is this a de novo or first-time ablation? Have they been ablated 2x, 3x, 4x, and is this like a redo procedure? If that's the better distinction, for me, I think a first-time ablation, if you want to use single-shot technology, go for it. Nothing has been ablated in this patient before. It's mostly an anatomical ablation, meaning we know the sites we need to ablate. We're not trying to chase down something fancy. We're just going in, and we're going to do the same work roughly in all the same patients when they're coming in for their first-time ablation, which is pulmonary vein isolation. Then in a lot of patients, now we're doing posterior wall isolation as well. You can get the PVI, we call it, the pulmonary vein isolation, as well as the posterior wall ablation done with any single-shot technology.

Some are easier to use than others, but I can use Farapulse and get that done very easily. Now when it comes to a patient who's been ablated more than once, second, third, fourth time, we call them redo ablations, there's a little bit more finesse in those patients, meaning we don't really have as good of an idea of what area of ablation we have to address because usually, it's someone else's work that's been done, the first ablation, and can't really speak to the quality of the work until you go in there to see the work that's been done. Usually, we assume that the pulmonary veins, which have been ablated before, especially in the era of PFA, they're probably going to still remain ablated, meaning that work is usually going to be good. In the days of radio frequency and cryo, perhaps we would question whether that work was good. Now with PFA, sure, you could still have shoddy jobs done by shoddy operators, but when you're going in for a redo ablation, I'm typically thinking, "Okay, I probably need to touch up a couple of areas here and there if it was due to bad work or work that didn't hold, but I'm not having to do the entire pulmonary vein isolation over again. Maybe I need to address a different area that's going to be a little bit more focal, more discrete area."

In these redo procedures, I tend to prefer focal ablation or catheters that allow for focal touch up of areas. That's where the true nuance of how at least I approach an ablation procedure for AFib changes. It's not so much paroxysmal vs persistent, but has this person been worked on before with PFA or have they not? For the redo procedures, I'm not really as excited about a single-shot technology like Farapulse. I may reach for something more focal like Medtronic's Affera. Volt does allow for a little bit of focality in ablation. They can selectively ablate from its catheter. Instead of saying the whole catheter lights up and delivers energy, you can select which portions of it, so that's nice. I really am excited by the more focal technologies coming to market, one of which was Abbott's TactiFlex Duo, which has got FDA-approved late last week. That's a focal catheter and the only second focal available catheter that's come to market other than Affera. It's more focal vs single shot, and that's going to relate to redo ablations vs first-time de novo.

[00:12:30] Now that the earliest cohorts of de novo patients treated with Farapulse are two years old, could you quantify the wave of redo procedures? I presume those cases are going to skew more towards Volt and Affera, but how is the redo wave changing your overall catheter requirements?

EC [00:13:01]: I think, first of all, it should be noted that there's no cure for AFib. You can ablate someone as many times as you want, you're not going to cure AFib. It's just not going to happen. Just like you can keep on drilling out cavities in someone's teeth, but if they live the same way with the same lifestyle, there's no cure to cavities even though people with cavities keep on having dental filling. That being understood, meaning there's no cure for AFib, you're going to have patients that come back with AFib after a single ablation or a second ablation or a third ablation. If they find value in symptom relief or peace of mind and having less AFib after each ablation, then they'll come back for their next ablation. Maybe it could be one year from now, two years from now, whenever, it depends on their health status. More and more of the ablations that I am doing are more skewing towards redo ablations. I've been at this for five-plus years. If I ablated someone in 2021, they're probably having some recurrence with AFib, and so I'm ablating them again, or the other thing is that there are a lot of patients that had an ablation the first time by someone who isn't comfortable doing a second, third, fourth ablation because they're really only just an entry-level electrophysiologist.

They're not that person that can comfortably handle having to chase down additional areas because all they are, are single-shot technology user. I'm getting some patients that were ablated by other electrophysiologists that are now trying to get relief because they know that their electrophysiologist may not do the second, third, fourth ablation. In those redo procedures, I tend to look at who I use the first time for ablation. Oftentimes, it's Boston Scientific because several years back, they were the really only vendor around. If it is Boston Scientific, then I often will say, "Well, let me try a different technology or vendor for their redo," either because it's a focal ablation and Farapulse isn't or because I say, "Well, this patient had their chance with Boston Scientific or Boston Scientific had their chance with this patient. Now let's try a different vendor, maybe there'll be a different or better outcome." That's at least how I look at it.

[00:15:32] Experts and EPs [electrophysiologists] in Interviews from Q1 2026 [see PFA Platforms – Q1 2026 Update – Sustained Adoption Outlook & Concomitant Procedural Applications – 11 February 2026] estimated that pure vein reconnection on redos occurs in fewer than 20% of patients, with recurrence more often driven by atypical flutters and scar-mediated circuits. Does that match what you're seeing? Does lesion durability meaningfully differ among the platforms you use?

EC [00:15:59]: Yes, and that's a really smart insight. We say that once you've subjected a patient to ablation, if you don't do a good job, that ablation, which causes scar to form, that scar can form more potential areas to cause AFib. The more you ablate someone, the more you potentially set them up for more arrhythmias, either more AFib or more atypical atrial flutter, so that's why it's a double-edged sword like, "Yes, you go in there and you do a PVI and a well-done PVI can have great impact." A poorly done PVI can just set someone up for additional arrhythmias because it was a shoddy job done. I enjoy treating atypical flutters and doing third, fourth time ablations. You're right, a lot of the times, the pulmonary veins are not reconnected. The work that was done the first time has held.

I would say that, that's a big improvement from the days of radio frequency and cryoablation where if a patient came back after getting ablation done by RF or cryo, I'll say, it's a 50/50 chance whether this residual AFib is from the pulmonary veins that were just not done well the first time or didn't hold over time vs some additional area, like you mentioned, scar-mediated atypical flutter that we have to chase down. More and more in the era of PFA, the veins are being cooked pretty well. Again, I can't say that across the board, but in general, they're being ablated better than they were before with cryo and radio frequency. I do think scar-mediated and areas outside the pulmonary veins are the bigger driver of the AFib that we see in patients that have already been ablated previously. There's only so much area in the left atrium or right atrium to ablate. As you start knocking out those areas, if there's still residual AFib or atrial flutter, that means you got to go searching in non-conventional areas.

[00:18:04] What are Farapulse's main strengths and weaknesses at present? How compelling are the enhancements Boston Scientific has made since the system came out as a first-generation offering a few years ago?

EC [00:18:31]: I think just in a big picture, the most compelling data for the safety, efficacy and efficiency of PFA ablation has all really been around Farapulse use. Now there are studies looking at 72,000 patients that have been ablated with Farapulse worldwide. That number used to be 10,000. Just over time and being for a long time, the only vendor for PFA for AFib ablation, all of the data that's out there is mostly with Farapulse. The data has just continued to reinforce the safety, efficacy and efficiency of Farapulse. That's a big comfort in knowing what you can expect and what you can't expect. What we know is that Farapulse is very good for the veins. It has two different catheter configurations, roughly speaking, you've got the flower and the basket. You can play with those as you see fit. We know that it might not be so good for areas that are outside the veins, either because that basket catheter or flower configuration catheter just isn't really good for focal areas or because maybe the waveform is not optimised for additional areas outside the pulmonary veins. The challenge with PFA ablation is that the waveform, meaning the energy output, from that ablation catheter is proprietary. No one knows what's in the secret sauce for that waveform. Every additional catheter that comes out has a proprietary waveform.

That waveform cannot be adjusted by the physician. It can't be changed. It can't be optimised. It can't be titrated in a real-world setting. What you get is what you have to deal with, meaning you push the button to deliver PFA energy from the catheter. You can push it once, you can push it twice, you can push it three times, but you're going to get the same energy that comes out and no one really knows what that energy signature is. That's why more and more ablation catheters for PFA keep on coming out because it's a proprietary energy source. No one really knows what the output is. It's also the reason why, as new ablation technologies come out, electrophysiologists like me are secretly hoping that it's a better energy output because we just don't know what it is. We can only hope that it's better. I think that's the long and short and looking forward ahead to my thoughts on Farapulse. It's a first-generation technology. We know what it can do, we know what it can't do, and we know that hopefully newer iterations of PFA will have a better energy output, but it's all proprietary.

[00:21:09] Boston Scientific's worldwide EP segment grew 9% in Q2 2026, with US growth of only 3%, and management is now guiding to roughly flat global EP growth in H2 2026, which is a marked slowdown. How much of this deceleration would you attribute to market saturation vs genuine market share loss? Where would you speculate the company's lost cases are going?

EC [00:21:41]: I do think there's a saturation. It's the same saturation that we would see in patients with heart attacks that need stents. It's the same saturation that we see in people with aortic stenosis that need TAVRs. There's just so many patients. Even if the demand keeps on growing, the rate of it is definitely slower than the rate of electrophysiologists performing ablations. If I had to choose between market saturation and just other vendors eating up their space, I would say, it's probably at least 60% market saturation. I'm here in Miami, and I feel like the trends hit Miami and Chicago and New York quicker than other places. I'm surprised that globally, saturation is occurring because I think there are still non-first world countries out there that are slowly dealing with this AFib pandemic. They're not having access to PFA, at least I didn't think so. I'm surprised that market saturation would occur globally. It went from one PFA vendor with Boston Scientific now to four commercially available PFA vendors. I'm sure there's more coming down the pipeline, Kardium, CardioFocus, Field Medical. Everyone is trying to get into the PFA game. It's getting to the point where we have more PFA ablation systems in the hospitals than rooms that we can do PFA ablations in.

It doesn't help Boston Scientific that they haven't really iterated on their first-generation Farapulse ablation catheter recently. Yes, they've created new catheters that look and deflect a different way, but it's still the same energy waveform. The output of the catheter is still the same, even though the form of what the catheter looks like has changed. Part of Boston Scientific's decrease in market share is that they just didn't care to innovate. They didn't care to innovate until all these other competitors came around and they're like, "Oh, shoot, now I have to invest in R&D again." You know what, Boston Scientific never created Farapulse. They bought Farapulse as a start-up. Boston Scientific doesn't inherently, to the best of my knowledge, have the R&D capabilities to create their own Farapulse system, nor do I think they have their own R&D capabilities to iterate on it to make it better. Their luck has run out. Unless they buy another start-up company, like they did at Farapulse, I don't really know what they're going to do to retain their market share.

[00:24:40] Boston Scientific is positioning the next-generation Farapulse Ultra for a scaled launch around mid-2027 and has initiated the FARADIGM trial for its next-generation PFA [pulsed field ablation] device. What would Ultra need to deliver regarding mapping fidelity, catheter versatility, dual energy or waveform to reestablish its leading position against the challengers, in both clinical trials and real-world settings?

EC [00:25:11]: All PFA systems are fairly equivalent when it comes to pulmonary vein isolation. Trying to harp on getting better quote at pulmonary vein isolation is yesterday's news. You mentioned earlier that in these redo patients or in these patients that have been previously ablated, when they have AFib again and have to undergo another ablation, it's going to be a different area. It's going to be scar-mediated. It's going to be outside the pulmonary veins. The energy waveform for any future PFA system, whether it's Boston Scientific or not, needs to be improved on so that people can report out on safety, efficacy and efficiency when you ablate other areas, the posterior wall of the left atrium, the anterior wall of the left atrium. If you want to grow the PFA market and you want to look outside of AFib and you want to look at the ventricles, then you have to have a different waveform for the ventricle of the heart. It's a thicker tissue. It's different tissue. It's not the same as the atrium. Again, the PFA waveform is proprietary. The PFA waveform is what drives the safety, efficacy and efficiency. Boston Scientific needs to come out with a better waveform. Right now, they're just coming out with different catheters that utilise the same waveform.

They would really need to not only come up with a new waveform, but do research trials that say that this waveform is effective in other parts of the heart that are beyond the pulmonary veins because I really think that's the next frontier of where PFA ablation for AFib is going to lead, in even PFA ablation outside of AFib in the ventricles. The crux of it is the energy output. The catheter waveforms, all these different companies, they're taking the catheter design of a competitor. Right now, Medtronic has a focal catheter. Medtronic's 360 ablation catheter, whatever they call it, is really just a single-shot basket, which just looks like Boston Scientific. Boston Scientific is trying to come out with a focal catheter because all they have is a single shot. Their focal catheter is probably going to look like TactiFlex Duo from Abbott or it will look like a small little globe like Medtronic. These ablation companies are spending too much time on trying to make the same energy, repackage it into a catheter that just is a competitor's catheter to try to eat away at their competitors' share with that catheter form. What they really need is just to have an improved energy output technology, which, I understand it's easier said than done, but that's where the next forefront is going to be for market share.

[00:27:53] Would you consider Farapoint – the focal PFA catheter for flutter lines and CTI [cavotricuspid isthmus] ablation – a copycat of competing devices, or could it be a true differentiator when launched?

EC [00:28:10]: If you're talking about treating atypical flutters, I use the current iteration PFA systems to treat atypical flutters already. I don't think trying to brand a PFA system as, "Oh, it can treat flutters," I don't think that's going to be novel because we already do it. It's not like we're not treating flutters, I'm still doing ablations in patients that have been ablated two, three, four times, and those patients have flutters. I'm doing it, and I'm treating it. I'm just saying the safety, efficacy and whatnot is not quite published on using PFA for those purposes. It's not specific to flutters per se. It's specific to treating areas that are scar-related that are outside of pulmonary veins. When they design the trial, they may say, "Okay, we're going to design this to treat atypical atrial flutters," but in reality, what they're saying is, "We're trying to develop a catheter that we can use to treat areas outside the pulmonary veins."

[00:29:16] Abbott's Volt received FDA approval in December 2025 following the Volt-AF IDE study. A KOL [key opinion leader] in the aforementioned Third Bridge Interview from February 2026 called it extremely appealing, citing the first-pass PVI [pulmonary vein isolation] efficacy rates above the traditional 70-75% threshold. Now that you've had some time to try it out, how does your hands-on experience compare to the trial data on efficacy, saline inflation technique and EnSite integration?

EC [00:29:53]: That's a great question. We had Volt here. If we didn't have it by December, we definitely had it by early Q1 2026. I've been using Volt for the last several months now. It hasn't been a game-changer for me. There was a lot more hype and promotion around Volt than their real-world practical experience warrants. That's just Abbott coming late to market and wanting to drive up a lot of fanfare for their PFA system. I give their PFA system kudos. They designed it from in-house. They didn't acquire some start-up. They took their time with their experience having mapped a lot of cases for Boston Scientific and their experience there and then developed their own in-house PFA technology, which I think is great. They didn't purchase anyone. That said, I'm not super impressed by Volt. Literally, if you look at it, it looks like a balloon with some electrodes around it. It looks like cryo. It looked like they were trying to either come to market with a PFA system that just could come to market quickly and wasn't really going to change much or they were trying to appeal to their cryo users, meaning they're trying to get electrophysiologists that were comfortable with cryo and maybe not comfortable with Farapulse to be comfortable doing PFA again.

Sure, their PVI percentages are better. Their isolation rates are, like you said, 70-80%. Is that because they have a different proprietary waveform? Who knows. Is it because their basket configuration is somehow superior? I don't think so. Is 70-80%, 100%? Is it 90%? No. What was the PFA PVI rate prior? It wasn't that much worse than what Volt brought. If you're a patient and you're going to say, "Hey, I can use this vendor and you're going to have, what, 60-70% freedom from AFib at one year vs 70-80%." That's not going to be that different. At that point, the 10-15% difference is more in the operator who's utilising the technology and less the technology itself. I've had recurrences using Volt already. It's not like Volt is the end-all, be-all either. Volt, I think, is interesting. I've used it for several months. I'm more excited about TactiFlex Duo that just got FDA-approved. I, for sure, am going to start swapping out Volt for TactiFlex Duo if I want to use Abbott going forward. They came out with Volt to get Abbott-friendly EPs excited that Abbott finally had a PFA system. The fact that they came out with FDA approval for TactiFlex Duo within the same year just means that Abbott knows that Volt is not going to be their workhorse catheter.

It's no different than Medtronic coming out with PulseSelect PFA first and then quickly getting everyone to Affera. Anyone who's using Affera for Medtronic is probably not using PulseSelect anymore. It was really just whether you want to call marketing scheme or whatnot or getting attention, the Volt to TactiFlex Duo progression is going to mirror what I think the PulseSelect to Affera progression was for Medtronic.

[00:33:37] What share of the US PFA market do you think Abbott can realistically capture by the end of 2027 with the TactiFlex Duo catheter roll out?

EC [00:33:50]: The good thing with Abbott is that they have a solid mapping workforce. TactiFlex Duo is entering into this focal ablation space where only Medtronic so far has had a footprint. Medtronic's footprint is good. I know I have a lot of colleagues that are up North and West Coast and Midwest that are really happy with Affera. In my impression, Medtronic's biggest efficiency with Affera is their mapping system. They've never been traditionally a mapping company, the way that Biosense, Carto and Abbott have been. I've always been reluctant to use too much Affera, even though their focal ablation, because their mapping technology and system is just I don't think that good. When I use Affera, I tell myself I'm using a better ablation technology, but taking a hit on the mapping side. With Abbott, with their TactiFlex Duo, I'm hoping that I don't have to take a hit anywhere, meaning I get the focal ablation benefit and I get to utilise Abbott's reputation or history or experience in mapping.

To get back to your question, again, my market in Miami, we are heavily Abbott users. I know that Florida's dynamic for Abbott is very, very different than the rest of the country, which really doesn't use much Abbott. They can eat away at Affera's market share with Medtronic, and simultaneously with Volt, they can eat away at Boston Scientific's Farapulse market share because then they have two different catheters, one's focal and one's single shot. They can enter in both ablation space.

[00:35:47] How well-positioned is Medtronic to capture market share in the complex and redo ablation segment? What is the ceiling for Affera adoption given its USD 3,000 price premium and lack of a dedicated LAAC [left atrial appendage closure] device? I appreciate that Penditure may not serve the same concomitant workflow niche.

EC [00:36:15]: Yes, I think Medtronic is definitely at a disadvantage because they can't offer the concomitant portfolio. That said, I used to be someone that would try to keep a concomitant procedure done with one vendor, meaning I would use a Boston Scientific Farapulse and then the Boston Scientific Watchman and try to keep it all within the same family, so to say. I've since realised that there's really no value to company loyalty for doing a concomitant because some patients do better with the ablation. The ablation and the appendage occlusion may be better served by different vendors. I would say the concomitant space is decreasing. There was a novelty to doing concomitants maybe about one year ago. Then since that year, CHAMPION trial didn't come out as positive. Reimbursements for LAAO have gone down. There have been a number of other trials that have indicated that maybe it's not so much black and white, where either you stay in your blood thinner or you do a Watchman. It could be a successful ablation may get you off a blood thinner long term. Now there's a third option, which is get a good ablation and maybe you don't have to be on a long-term blood thinner.

Even though I think Medtronic have a loss by not providing an appendage closure device, I don't think that loss is as significant as it was one year ago. I think it's less. In terms of mapping for Medtronic, they're getting better at mapping. The challenge with Medtronic's mapping is that, one, you have to have obviously a software that's good at mapping, and that just takes time to develop. Remember, Medtronic never created Affera in-house, just like Boston Scientific, they bought Affera as a start-up. Medtronic doesn't have any experience in the mapping space that they've home-grown in terms of a software, so they got to get good at that. On top of that, they never had a field force to support marketing, meaning they never had mappers in the field before. Now all of a sudden, they need to hire a whole bunch of people to become essentially mappers. Now you have a very immature field force mapper and you have a very immature mapping software. Again, that was an issue for them that they've been trying to improve on over the timeframe of PulseSelect and Affera. It's been a couple of years that they've had time to improve on it, and they have improved on it. I don't think the mapping will be as big of an issue given enough time. In that same amount of time, now you have another focal ablation catheter with TactiFlex Duo, you have all these other PFA vendors.

[00:39:03] How would you compare the major mapping systems today – Boston's Opal HDx (now on its 7.0 software release), Medtronic's Affera, J&J's Carto and Abbott's EnSite – on accuracy and workflow innovation? Which platform do you think is superior and actually gaining share in the mapping layer?

EC [00:39:27]: Nothing beats longevity experience and clinical trials that look at how good a mapping system is. In that regard, I think the traditional mapping powerhouses are the ones that have been there since the RF days. Biosense Webster, Carto, huge in mapping, unfortunately, not so great in PFA ablation. Abbott has been there as well. That's why I think Abbott has a really good footprint in the mapping area. Again, whether they have great mappers to support it, that's just dependent on how they hire. From a software standpoint, they have great legacy that they've improved on software. Opal HDx is an interesting one. Boston Scientific had some mapping systems called Rhythmia that were there just before PFA became a big thing, but they were never really a big player. They were a distant third in the mapping world. Opal HDx, all those upgrades, 6.5, 5.5, they keep on going up in number, those have always been software upgrades. They haven't really been hardware upgrades, meaning they haven't created a better mapping catheter. What's their mapping catheter? Farawave.

They use their Farawave largely as their mapping catheter, but that's still the first-generation catheter that they use for ablation that they've just tried to use the software to reconfigure it to allow for mapping. Whether they call Opal HDx 25.0, if they're still using the same mapping catheter, which really isn't a dedicated mapping catheter, then it's just like all marketing. They are coming out with the next iteration of Opal HDx will be an actual change in how they map from the ablation catheter. They're adding another electrode, so each spline serves its own reference point, something like that. Everything up to now with all their Opal HDx version upgrades, in my mind, are just little baby steps that haven't made a big difference. Their next mapping upgrade, I think, again, is a hardware change with a different type of mapping catheter. That's exciting. I rarely use Opal HDx for mapping unless it's a de novo paroxysmal patient where the mapping really doesn't matter. Their mappers are relatively new and their software is better than Medtronic, but definitely not as good as Abbott or Carto. Then Affera's mapping, I think we talked about that already. I think Medtronic is a distant fourth for mapping.

[00:42:15] What changes have you observed in concomitant PFA/LAAC volumes over the past 3-6 months? To what extent have reimbursement cuts to RVUs [relative value units] for standalone Watchman cases driven more cases towards the concomitant workflow?

EC [00:42:37]: I think there was a novelty with concomitant first was displayed to the world through OPTION trial, like, "Oh, if you do a Watchman at the time of a PFA ablation, your stroke risk will be less." I think that concept has become more nuanced, meaning when CHAMPION trial came out, clearly, CHAMPION results were not as hopeful as Boston Scientific leadership would have wanted it to be. When they did the reanalysis on CHAMPION, they again showed that patients who had the lowest risk of stroke were the ones that did have ablation and Watchman done. It didn't mean that it had to be done in a concomitant way. They could have had their ablation and Watchman done at two different encounters. They could have been offset by one year, six months. They didn't need to be done at the same time. While I do think that it's good to have both procedures done to really drive down stroke risk, I think the jury is out there as to whether or not having them done at the same exact time is how it needs to be done. Also, during concomitant procedures, the Watchman or the LAAO is reimbursed at 50% less, at least to the physician acknowledgment.

If the physician acknowledged USD 100 for doing a standalone Watchman, they only get USD 50 if they do the Watchman with the ablation. It's an automatic 50% decrease in physician acknowledgment of productivity. That's not really incentivising electrophysiologists to do something additional. I think the fact that in 2026, CMS cut the reimbursement for physician acknowledgment on productivity for the Watchman, they got cut by 26% from 2025 to 2026. Now you're telling me if I want to do a concomitant procedure, unless I think it's truly indicated, then sure, I will do what's indicated. If I'm just trying to upsell a patient and try to do more in the same setting because I can, the incentives are not really there financially. The research compelling it is not really robust. The only electrophysiologists who are really pushing concomitant are the ones that are focusing on quantity of procedures done instead of focusing on the quality of the procedure done, and so concomitants are coming down.

I've had referring cardiologists tell me that they're annoyed that they send their patients to an electrophysiologist for an ablation, and then the electrophysiologist says, "Well, I'd like to do an ablation and the Watchman," and the referring cardiologist says, "Why? I send them to you specifically to address the ablation portion of it. Why are you trying to convince me to tell the patient they now need a Watchman? I didn't talk to them about that." Now there's pushback from the referrings. I've had patients also tell me, "Okay, I understand that you think both procedures are helpful, but I really only want to do this one aspect of it, and maybe we can do the other aspect a different day if I really need it." I say that's fine, too. Concomitant overshot itself. There was a lot of novelty and now there's a lot of pushback in all aspects of concomitants going forward. For me, I don't know if I mentioned this earlier, but I think in 2025, 30-40% of my LAAOs were concomitant. In 2026, it's now down to around 20-25%. I bet you in 2027, it will probably stabilise somewhere at 15-20%. I just think the number of patients that need both done at the same time is less than it needed to be.

[00:46:19] With Abbott now able to pair Amulet with Volt on an EnSite mapping foundation, are you seeing any traction in its competitiveness against Watchman, or is Watchman still dominant?

EC [00:46:30]: Great question. I would say, in 2025, I was 100% Watchman. When you told me LAAO, it was synonymous with Watchman. This past year, I've started to do more Amulets. I've realised that some anatomies, some appendages are just better closed with an Amulet instead of a Watchman. The two devices are very different in their form. The two devices are very different in their dimensions. I do think that the Amulet just takes a little bit more of a technical skillset to feel comfortable implanting. There's been a lot of trials that have pointed out that complication rates, bleeding rates with Amulet are higher than with Watchman. That said, this new Amulet 360 device, which is supposed to come out potentially as early as end of December, end of this calendar year, may be as safe as Watchman. For me, in 2025, I was 100% Watchman. Now I'm probably 85-90% Watchman and the rest are Amulet. Over time, the market share of Amulets in my LAAO split will be higher, especially with 360 coming out, Amulet 360.

[00:47:51] Ancillary staffing shortages – such as anaesthesia and EP tech attrition, as well as a reliance on travel nurses – have been a binding constraint on procedural growth. How pervasive are those bottlenecks? Have they eased or worsened over the past couple of quarters?

EC [00:48:08]: That's a great question. I was asked this question in a different way not too long ago. It used to be in the days of radio frequency and cryoablation that the time it took a patient to physically leave the pre-procedure area and come back to the pre-procedure area, the bulk of that time was the time it took the electrophysiologist to do their portion of the procedure, which was the mapping, the ablation, the access. A minor amount of it was the time it took to transport the patient to the room to get the anaesthesiologist to provide the anaesthesia sedation and whatnot. Now with PFA, the bottleneck is no longer with the electrophysiologist. I can do a PVI if I only did a PVI. I could probably do it in 30-45 minutes or less. It still takes about two hours for that patient to get to the room and back. Now the bottleneck is the anaesthesiologist. Some of them are very old school and they insist on using general anaesthesia for everyone. Some of them are lazy, and they want to just put in general anaesthesia and then have their CRNA supervise the machine covering the case. They don't want to be responsible to be in that procedure the entire time, managing an airway that isn't general anaesthesia.

I get annoyed sometimes that I'm getting faster as an electrophysiologist. The PFA technology is making my portion of the work faster, but I'm hitting a bottleneck every day with room turnover, with largely the anaesthesiologists insisting that they still want to give the same amount of anaesthesia they did the radio frequency and cryo patients and use general anaesthesia. They don't want to test moderate sedation, which is the same type of anaesthesia one gets with colonoscopy. You go to sleep, you breathe on your own, you wake up, you recover, you go home. It takes less time to recover those patients. It takes less time because you're not inserting a breathing tube before and after the procedure, inserting and removing it. For sure, the bottleneck is no longer with the procedure. It's no longer with the technology. Now there's PFA systems that are saying that they provide nanosecond ablation. That's great, but what does that mean for the electrophysiologist? My procedure is now down to 30 minutes from 45 minutes, but the bottleneck is not me anymore. You want me to be faster, but nothing changes. I sit outside and drink coffee longer. The technology shift and the marketing for nanosecond PFA ablation vs millisecond or whatever we have now, that's not really going to meaningfully move the dial in the space of PFA ablation. The bottlenecks are outside of what the electrophysiologists can do at the moment.

[00:50:55] With ASC [ambulatory surgery centre] billing codes now live, some private EP groups are targeting a 3-5-year migration to ASCs to lift productivity. How are you evaluating that shift in the market? How quickly can AFib ablations move into ASCs and what's still inhibiting the pace of migration?

EC [00:51:14]: It's slow. Look, 1 January 2026, so what is that? Nine months ago, nine-plus months ago. CMS said, "We have a code for reimbursement for AFib ablations to be done in ASC." I can tell you that my group, which is a private equity-owned group, has been salivating at trying to get an AFib ablation done in ASC. It just takes a long time from building the site to getting approval for the site, to getting regulatory approval, to getting credentialing, to having CMS come and do site visits. To this day, we still have not done our first AFib ablation yet despite knowing well in advance that 1 January 2026, the approval code would manifest. There's the dream of creating an ASC and then there's a reality of how long it takes. I don't know of any places in Florida that have sprung up an ASC as quickly as they wanted to. The other thing is, ASCs will maybe allow me to do 10-15% of the ablations I do now in an ASC. It has to be the safest patients where I don't think anything bad is going to happen. Everyone keeps on saying, "Well, the ASC, you're going to do the same ablation that you would otherwise do in a hospital setting." That's just not true. The only reason why we're doing it there is because of margins and profit.

We're not going to have as much technology there. We're not going to have all the vendors. We're not going to have all the support. We're not going to have CT surgery there. We're not going to have neurology there. If a patient has a stroke, everything is, "Calling 911. Get the ambulance over and we'll send them out." Do I think that's going to be commonplace? No. Do I think it's going to happen? Inevitably. In 10 years from now, we'll be doing a healthy amount of ablations in an ASC, but that's going to be more because we're catching AFib earlier and not letting the patients get as sick with it. I don't think in the short term, ASCs are going to be a new outlet for ablations, but they have to be built. Also, a big thing that no one's really talked about is how are EPs going to be incentivised to do their ablations in ASC. Why would I care to do an ablation in an ASC unless you give me some sort of incentive to do it there? Are you going to give me higher acknowledgment of reimbursement or productivity if I take the risk of doing a patient in an ASC without the same tools that I usually have, without the same resources and support that I have?

If you're not incentivising me to do it, and I'm just making money for my employer and I take all the risk, why would I do that? That's the big elephant in the room that a lot of these private equity private practices are dealing with is, "Okay, let's say they built the spot. Let's say they've bought all the vendors. Let's say it's operational." A lot of electrophysiologists are saying, "What's in it for me to take on the risk of doing this procedure in a new space that's never been done before?" I think that's a conversation that needs to be had, unless it's a private practice EP that built the ASC from scratch, which takes a lot of resources, that's not the case in most ASCs.

[00:54:45] In your screening call, you posited that PFA reimbursement won't get cut, arguing that if CMS [Centers for Medicare & Medicaid Services] cuts it further, it will kill volumes. That's a notably more sanguine view than those of experts in previous Interviews, who saw device manufacturers ultimately absorbing the pressure via lower catheter prices. Could you expand on your view on the coverage landscape and reconcile it with the professional fee trajectory already seen historically on Watchman and legacy ablation codes?

EC [00:55:28]: I agree on that. First of all, the reimbursement for PFA, it's not specific to PFA. It's just reimbursement for AFib ablation. It's the same CPT code, 93656 or something, as it was in the days of RF and cryo. There may be a code that's specific to PFA, but the code that we bill all the time when we do an ablation in a hospital setting, which is the only place that it can be done outside of an ASC, is the same code as before. It's not a unique or different code, the PFA. That code has been cut in reimbursement over and over and over again. That code has been cut on its own. It's been bundled with other codes. The only reason why I don't think PFA can be cut more, and, again, it's not PFA. I don't care what other new technology comes out that you can do AFib ablation with. It's a code that's been cut for 2-3 to 4-5 years. Can they cut it more? They can always cut it more.

The reason why it's getting cut is because the technology is making the procedure faster. If the PFA portion done by an electrophysiologist is only 30 minutes, 45 minutes, one hour or less, there's less justification to cut it. It used to be an AFib ablation may take 4-6 hours, but now the current reimbursement reflects an ablation that's done probably in one hour or two, maybe less. There's not really that much room to cut it more. It's already been cut many, many, many times.

[00:57:11] Who do you think will emerge as the dominant PFA player over the next 2-3 years? What would you need to see regarding safety, efficacy and efficiency to materially shift your own volumes?

EC [00:57:30]: I think if PFA goes down this path of massive competition and very little distinction between vendors, then what's going to happen, what's going to distinguish vendors and market share is going to be those that invest heavily in R&D or have a great way to buy out start-ups that bring something novel. The PFA systems that are out there are either first generation or, in some cases, second generation, like Medtronic second generation and Abbott second generation with TactiFlex and Boston Scientific coming out. They're all fairly new. In the long run, when you're looking at third, fourth, fifth generation devices to the point where no one even cares to count what iteration it is, the only way to have more iterations is to have R&D backing. You have to throw in a lot of resources in trying to get the next best thing out there. Medtronic has been a huge leader in R&D. They're the international global number one biomedical company, but I think that's because their mantra has always been investing in R&D. They do charge a premium oftentimes in their capital, like you alluded to before, but they have R&D. That said, Affera, they bought it. That's not really their own in-house R&D.

The other one is field force. For us, we use Medtronic for our implantable pacemakers, defibrillators, but they have the best customer service. They have the best, most reliable field force. Their field representatives are there and they're present, as opposed to, let's say, Biotronik with their pacemakers, defibrillators. You call a Biotronik rep because you have a case that needs covered and they're like, "Well, can you push it back one hour?" We're saying, "We're calling you, we're the client. Why are you telling us to change our plan?" That's not the case with Medtronic and their pacemakers and their field force. They're always available. Field force is going to be a big one, but second only to R&D and technology. For example, Carto, Biosense, they couldn't keep up with the technology. They came out with a PFA catheter that had high stroke risk, and then they overnight lost all their market share. It's a wild, wild west when it comes to the PFA marketplace. It's not going to be specific to any name brand anymore. It's not going to be the Cartos and Abbotts. It's going to be the people that are looking to heavily invest in R&D to always stay ahead instead of sitting back and saying, "Oh, I came out with Farapulse. I don't need to iterate until I have stiff competition." That's why Boston Scientific is losing their market share.

GC [01:00:21]: I think it's a good point to close. It was a great Interview.

EC [01:00:50]: Awesome. Thank you. The only last thing I'll leave you with just in 10 seconds is that Boston Scientific is doing their annual AFib symposium, it's called TransformAF. It's going to be the weekend of 26 September in Orlando. I am attending it. They usually showcase their upcoming products, their newest Watchman, their next-generation ablation. I think that's something to think about because Boston Scientific, even though they're losing ground, they're probably still a market leader, and they're definitely looking to showcase to their electrophysiologists what they have in the pipeline. I'll have that information in a couple of weeks once I attend that event.

GC [01:01:27]: Yes. Good to know. I'm glad it's not too far for you either. Great. Doctor, I appreciate it. I hope you have a great rest of your week, and we'll be in touch.

EC [01:01:36]: Okay. Take care. Thank you again. Bye.

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