Pulsed Field Ablation Heats Up: Insights from Medtech Titans at J.P. MorganPulsed Field Ablation Heats Up: Insights from Medtech Titans at J.P. Morgan

The competition for market share in the pulsed field ablation (PFA) space will be even more intense this year than it was last year. So, it is no surprise that PFA, a promising new ablation modality for the treatment of atrial fibrillation, was a huge talking point during the J.P. Morgan Healthcare Conference last week.

Here's what emerged during the conference about PFA from each of the three big contenders: Boston Scientific, Medtronic, and Johnson & Johnson.

Boston Scientific CEO Mike Mahoney: We're Committed to Leading This Beyond 2025 and Becoming the Market Share Leader in This Terrific Field

Boston Scientific snagged FDA approval for its Farapulse PFA system in late January 2024. IMAGE COURTESY OF BOSTON SCIENTIFIC

"We're only 10 months into our launch in the U.S. ...What's remarkable is the transformation and PFA adoption from the standard radiofrequency and the standard cryoablation," Boston Scientific CEO Mike Mahoney said.

Mahoney estimated that, globally, at least 60% of all ablation procedures will be done with PFA.

"So it's been adopted very, very quickly, and we are the clear market leader in this, and we intend to expand our market leadership position in 2025 and beyond through new account openings, launching in China and Japan, continuing to scale out our Opal mapping integration system, and new releases of clinical data," Mahoney said. "We're also committed to leading this beyond 2025 and becoming the market share leader in this terrific field."

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One way the company expects to do that is through venture investments in the field that will ultimately compliment Boston Scientific's internal portfolio. The company also plans to continue to lead the way in clinical science as it relates to PFA. And finally, the company plans to pursue broadened indications toward PFA being a first-line therapy.

"Everyone needs to understand that all PFA is not created equal, and the results that you get with any particular system is just inherently dependent on the waveform, the energy source that's used, the catheter design, and the dosage recipe," said Kenneth Stein, MD, global chief medical officer at Boston Scientific. "Now, even though we're only 10 months into our launch in the U.S. and months into our launches in China and Japan, we've already treated over 200,000 patients successfully with the Farapulse system. We've published clinical data and outcomes in almost 20,000 of those patients, and what I can tell you is our experience, and our published experience has a safety profile that is second to none and an efficiency profile for physicians that is second to none, and now we're seeing data published that actually shows efficacy when you look at the atrial fibrillation burden that's superior to legacy ablation sources. ...And that's what's behind the success of the launch, and that's what's behind our leadership position today."

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Medtronic CEO Geoff Martha: The more physicians use this technology, the more that they like it

Medtronic won FDA approval for its Affera PFA System in October 2024. IMAGE COURTESY OF MEDTRONIC

Medtronic CEO Geoff Martha estimated that PFA represents a $9 billion segment that is growing in the mid-teens with a strong growth runway in front of it. The company has two FDA-approved PFA technologies, Pulse Select and Affera.

Martha said the company has received "an overwhelming customer response and physician demand," for these technologies and is significantly expanding its manufacturing capability to handle the demand, as well as hiring mappers ahead of account activation. While Medtronic has always been strong in the electrophysiology (EP) space, most of that strength has been in cardiac rhythm management.

"Now, with this new technology lined up, we've made a lot of new friends in the EP world, and we're in the high-volume centers," Martha said.

He also emphasized the company's safety data on both its PFA catheters. "We've got really strong safety data on both of these, and as we've seen over the last week, safety here really matters."

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That comment was no doubt a dig at Johnson & Johnson's Varipulse, which J&J has voluntarily paused commercialization of in the United States amid stroke reports. Sean Salmon, EVP and president of Medtronic's cardiovascular business, made another dig at Varipulse during the Q&A when he was asked how big of an opportunity it opens up for Medtronic as it launches at the same time as the market leader in EP is pulling back in PFA.

"I don't think the catheter you're referring to had a whole lot of traction or interest anyway," Salmon said. "For us, it removes a lot of the question around, 'should I wait for something from my installed capital, or should I buy this new, better thing?' I think that's an easier decision today."

J&J CEO: We're working very hard to bring Varipulse back into the U.S. external evaluation

Johnson & Johnson scored FDA approval for its Varipulse PFA System late last year. Last week, however, the company halted U.S. cases to investigate neurovascular events observed in four cases. IMAGE COURTESY OF JOHNSON & JOHNSON

Joaquin Duato, CEO at Johnson & Johnson, addressed the recent news that the company halted all U.S. Varipulse cases as the New Brunswick, NJ-based company investigates the cause of four reported neurovascular events.

"We are in a limited market release in the U.S. in an external evaluation, and in the process of the external evaluation, we have identified a number of neurovascular side effects, four cases in particular," Duato said. "In an abundance of caution, we have decided to stop our external evaluation as we communicated. And that's why we do an external evaluation to be sure that we have the right configuration."

Duato reiterated that the company continues to sell the PFA device outside of the United States in countries where it is approved.

"We're working very hard to be able to identify the root cause and bring Varipulse back into the U.S. external evaluation," Duato said. "Patient safety, for us, is the most important priority. And in abundance of caution, we are in connection with the investigators and the medical advisers that were working in the U.S. external evaluation."

He added that the company is committed to developing "the best overall portfolio in PFA as well as in RF."

"And keep in mind, this is not only about one catheter; this is about the combination of your generator, your suite of catheters, your mapping system, and your mappers. So we are fully committed to remain leaders in ablation in atrial fibrillation, both in RF and in PFA.