Since the FDA’s approval of the first pulsed field ablation (PFA) system in the U.S. last December, PFA technology has rapidly reconfigured the electrophysiology market in the U.S. and ramped up sales of PFA systems in Europe. The shocking speed of PFA’s adoption continues to reverberate through the industry, but the benefit appears more widespread than early reports indicated.
PFA provides an appealing alternative to cryoablation and radiofrequency ablation, which often cause damage to non-targeted tissues, particularly the esophagus and phrenic nerve. PFA uses a non-thermal energy administered in high-voltage, very brief pulses to kill the cells causing arrhythmia without collateral damage to other tissues. It also substantially reduces the time needed for the procedure, has higher success rates and requires fewer repeat procedures.

Boston Scientific Corp. received CE mark (i.e., European marketing approval) for its Farapulse system in 2021, where it had been used in more than 40,000 procedures before gaining U.S. FDA approval in January 2024. Medtronic plc gained CE mark in 2023 for its PulseSelect and Affera PFA systems and for PulseSelect in the U.S. in December 2023. Johnson & Johnson’s Varipulse, Cardiofocus’ Centauri and Jinjiang Electronics’ Lead-PFA also have regulatory approvals in either the E.U. or APAC.

The adoption of PFA in the U.S. has been “unprecedented” and “exceeding sky-high expectations,” according to analysts. As a result, projections of the market size and market share for PFA have been repeatedly revised upward.

In our September 2023 report on the electrophysiology market, Clarivate projected that by 2028, PFA would represent 50% of the U.S. ablation market and would have a total global market value of $3 billion. Based on brisk uptake in the latter half of the first quarter, it appeared that PFA would account for at least $1 billion in sales by the end of 2024 .

At the Heart Rhythm Society meeting in late April, industry leaders in the U.S. reported having already switched 50% to 70% of their cardiac ablations to PFA – just two months after the launch of the two currently FDA-approved systems, Medtronic plc’s PulseSelect and Boston Scientific Corp.’s Farapulse. Based on that adoption rate, combined with brisk sales in Europe as Boston Scientific resolved supply issues and PFA approvals in the Japanese and Mainland China markets, year-end 2024 projections increased PFA market share to 40% with a market value of $1.5 billion by mid-2025.

Second quarter results showing a 125% year-over-year increase in electrophysiology revenues for Boston Scientific, which has emerged as the dominant player in the market, indicate that even those estimates may be too low.

Broader impact of PFA adoption
So, how has PFA adoption affected other companies and other types of ablation?

Cryoablation hit hard: Both Boston Scientific and Medtronic plc noted that the quick uptake of PFA resulted in more rapid than expected declines in cryoablation. Medtronic had said early on that its PFA system, PulseSelect, replaced competitors’ radiofrequency (RF) systems and its own cryoablation system about equally. In May, the company posted mid-single digit growth in cardiac ablation revenues in the fourth quarter of its FY 2024 noting that PFA uptake largely offset a drop in Arctic Front demand. Cryoablation accounted for about 25% of atrial fibrillation procedures in 2023. That’s likely to drop to 15% or less this year in the U.S.
Radiofrequency ablation proportion declining, too: Radiofrequency accounted for 75% of AF ablation volume in the U.S. last year. Because it is used in conjunction with PFA in about 20% of cases, it is less likely to be fully squeezed out than cryoablation. Still, industry leaders report switching up to 50% of their RF procedures to PFA already. The drop will likely be slower than in cryo, however.
Increased appeal for dual-energy systems: Sometimes a situation calls for RF, but physicians like the ease and efficiency of PFA. That creates space for dual-energy systems in development by nearly all players in the market.
Rising volumes benefit everyone: Overall U.S. ablation volumes had been growing at 5% to 10% annually, but the PFA has expanded the market even for other ablation technologies. Abbott Laboratories reported 20% growth in its (non-PFA) ablation catheters in the second quarter. While Johnson & Johnson’s growth in electrophysiology was down from the 20% or better rates seen through 2023, the 11% growth in the U.S. and 16% growth internationally reported in the second quarter indicates increased demand for its non-PFA systems as well.
Continued growth creates opportunity for multiple players: The ablation market is expected to post strong double-digit expansion over the next three years, with the total number of procedures at least doubling in the next two to three years. With the global atrial fibrillation market at $6 billion today, that rate of growth would push it to $12 billion by mid-2027, if not sooner, with PFA accounting for about 70% of the market.
Broader patient pool fuels expansion: In 2023, new guidelines from the American College of Cardiology, American Heart Association and other medical societies recommended ablation as first-line therapy for patients with atrial fibrillation based on the EARLY-AF and PROGRESSIVE-AF studies showing its superiority over drug therapy for rhythm control as well as for patients with heart failure and reduced ejection fraction. In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients.
International markets approvals tick up: Boston Scientific has approvals now for Farapulse in Australia and China and expects approval in Japan later this year. Johnson & Johnson’s Varipulse received approval in Japan in January. Japan and China are each estimated to be $1 billion opportunities for PFA over the next decade.
What’s next?
Medtronic’s premium PFA system, Affera, is expected to gain U.S. FDA approval in the fourth quarter, with Johnson & Johnson’s Varipulse system close behind, so competition will pick up. Still, analysts and providers project that Farapulse, which has more than 70% of the global market today, will continue to dominate at least through 2025. Abbott’s Volt should join the party in early 2026.

With PFA heating up, interest in acquiring smaller companies in the space to leapfrog the competition or gain another advantage in adjacent markets will also increase. Companies of interest in this regard include Atricure Inc., Field Medical Inc., Pulse Biosciences Inc., Adagio Medical Inc., Acutus Medical Inc., Cardiofocus Inc. and Kardium Inc.

Article source：Clarivate™