First Look: Boston Scientific’s next-gen Farawave Ultra PFA catheter

Boston Scientific‘s working on an investigational pulsed-field ablation (PFA) catheter that could expand the Farapulse system’s lead over the competition.

The device developer plans to launch its third-generation Farawave Ultra PFA catheter in the first half of 2027, following up on the Farawave PFA ablation catheter that won FDA approval in January 2024 and the Farapoint PFA catheter that was approved in January 2026.

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Boston Scientific is also developing the investigational Faraflex PFA catheter that combines ablation and mapping, with the goal of making it commercially available in 2028.

“Electrophysiologists love mapping,” Boston Scientific EVP and Atrial Fibrillation Solutions President Nick Spadea-Anello said in a Medical Design & Outsourcing interview.

“They love to map because it gives them more information, and they feel like they get more precision in being able to ablate these arrhythmia,” he continued. “The next-gen Farawave Ultra will have higher-definition fidelity for mapping as well as the excellence and the experience we’ve seen with hundreds of thousands of patients.”

Boston Scientific will soon — if it hasn’t already — hit 1 million patients treated with its PFA technology. The company’s Farawave device is the most prescribed catheter in the world for PFA, a minimally invasive catheter procedure EPs use to treat atrial fibrillation (AF or AFib) by scarring heart tissue to block irregular heart signals. The nitinol-enabled catheter uses the nickel-titanium alloy’s superelastic properties to deploy inside the heart in the shape of a flower or a basket.

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PFA is one of the fastest growing medtech markets and still relatively new.  Medtronic’s PulseSelect PFA system won the race to FDA approval in December 2023 and added to its portfolio with Affera catheters as Johnson & Johnson MedTech and Abbott developed and launched their own systems.

“We initially came out with that flower basket Farawave catheter that was mostly just a therapeutic catheter,” Spadea-Anello said. “Then we made it integrated, and each one of those splines had one electrode on the petal that allowed you to get an image and map. But you were only able to get a certain level of fidelity in the mapping system. Ultra has 20 electrodes, or five electrodes per spline on the pentaspline design. Those 20 electrodes will give you a higher-definition mapping capability when doing PFA with an all-in-one catheter: a therapeutic catheter and a mapping catheter.”

The following has been lightly edited for length and clarity.

MDO: You’re selling PFA catheters against competing technology. Why should EPs pick yours?

Spadea-Anello: “It’s a highly strategic, competitive space. We transformed the space a few years ago. For decades, people were using radiofrequency energy — for the most part, some people were using cryo energy — to ablate cells in the heart that were acting erratically. But we knew there was a purpose for a safer modality. We had a better solution, we felt, that could be safer and more effective. That’s when we made a bet over a decade ago on Farapulse and PFA energy or electroporation, being more targeted on the cells you want to terminate, versus terminating cells like in the esophagus or other areas when you’re ablating the heart. Because every year, if there were a million AF ablations throughout the world that were being conducted, 200 or 300 people were expiring because of an atrial esophageal fistula where when you were terminating those cells in the heart it would penetrate through the esophagus and patients had catastrophic events. It was a low number, and in medicine, you’re going to have some sort of consequences. Well, we’ve treated over a half a million patients, and I’d say the field treated probably a million patients, and we have yet to see an atrial esophageal fistula. And it’s as effective as RF energy and it happens to be even more efficient. An average RF ablation would take anywhere from 60 to 90-plus minutes. You can do a Farapulse procedure in relatively 30 minutes.

“Why us? We’ve done the most. We were the pioneer of the technology. We were the first in the world to offer it to patients and it’s the most studied device in the world. It’s not just the catheter and the energy, but the waveform in the generator that actually allows that to work differently. All RF energy pretty much works the same in terms of the energy, but the catheters may be slightly different and the mapping may be slightly different. We’ve disrupted the space because it was primarily RF with some cryo, and now you’re looking at high percentages — we think 70% plus to be PFA, and that’s going to be probably approaching 80% plus PFA in the U.S. here in the coming year or two. We’re excited because we were behind all of that and we transformed the space. We like for people to believe that what we know in creating the waveform that’s safe and effective is truly differentiating, and the body of evidence that we have that supports that.”

Everyone likes to keep the details of their waveform secret, but what’s special about yours?

Spadea-Anello: “If I told you that, I’d get in big trouble. There’s only a few people in the company that really understand the algorithm. All of these algorithms work in a specific way, but some of it is obvious, and it’s the catheter design and where the electrodes live in our flower catheter, for example, for Farawave. We’ve got on the pentaspline design catheter electrodes that live on each of those petals, and how that energy is sent to those petals or those electrodes and how it interacts with other electrodes, the design of how it communicates from one electrode to the next spline, the sequence of that, the pulse width associated with that, the engineering behind that, is unique to our catheter. So the catheter and the waveform is truly what gets you the results as well as the applications. They’re the three key factors that give you efficacy in PFA.

“We’ve got engineers that have Ph.D.s who are specifically focused on just waveform development at the cellular level. And we’ve been lucky because there are electroporation specialists throughout the world, and we happen to have a lot of them that are Ph.D.s that work at our company because it’s not just about today’s waveform. We always say that not all PFA is the same — and I believe all the strategics would tell you that — because every catheter is designed a little bit different, and how that energy comes out, whether it’s slightly different in the pulse width of when you send the stimuli from the generator to the catheter, and how it interacts with the electrodes, that, quite frankly, is what makes a catheter, or an energy efficacy, different from one catheter the next. So even our Faraflex catheter we’re developing and our Farapoint catheter, they’re different because of the different catheter designs and waveforms to get the depths we need to terminate these cells.”

Previously: Brad Sutton on Boston Scientific’s PFA advantage and advice for medtech pros