Medtronic Steals the Spotlight in PFA

The spotlight is now on Medtronic, as the medtech giant is the first to win FDA approval for a pulsed field ablation system (PFA).  The Dublin-based company secures the nod before Boston Scientific which also has a PFA system being reviewed by FDA.

Medtronic’s PulseSelect Pulsed Field Ablation (PFA) System is for the treatment of both paroxysmal and persistent atrial fibrillation (AF). Commercialization for the device in the U.S. is slated to begin in early 2024.

Approval for the PulseSelect Pulsed Field Ablation (PFA) System comes about one month after the device won CE Mark.

PulseSelect is a 9Fr bidirectional, circular array catheter with nine gold electrodes that delivers a controlled biphasic, bipolar waveform to user-selectable electrodes. The circular catheter is also capable of recording PV and atrial potentials and can also perform pacing. 

"Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency.  It's a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients," said Rebecca Seidel, SVP and President of the Cardiac Ablation Solutions business. "The PulseSelect PFA system, together with the CE Marked Affera mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence."

The competition in the PFA market will be intense in 2024. Boston Scientific is waiting in the wings with its Farapulse technology. Marie Thibault, an analyst with BTIG, and former managing editor of MD+DI, posited a potential timeline for Farapulse’s approval. (Editors Note: Boston Scientific inherited the PFA technology when it acquired Farapulse in 2021.)

“Medtronic said in May 2023 that they filed their PMA with FDA, although the exact timing is unclear,” Thibault wrote in research notes. “If we assume they submitted it in April, this would imply an 8-month review. Boston Scientific noted on their Q3 earnings call in October that they submitted Farapulse to FDA. If we assume a similar 8-month review timeline, we could potentially see Farapulse approved in early 2H24.”

Johnson & Johnson MedTech is also developing its Varipulse PFA catheter.

BTIG analysts conducted a poll of 25 U.S. electrophysiologists, interventional cardiologists to see how they would adopt PFA technology. The analysts asked the physicians to assume a scenario with PulseSelect and Farapulse winning a nod from FDA on January 1 and J&J’s Varipulse securing an FDA win January 2025.

Thibault wrote that the results from this scenario show that “in the year following FDA approval for Farapulse and PulseSelect, Farapulse is expected to secure 14% market share, while PulseSelect will be used in 9% of cases. This shift comes from an 18-point decline in RF share and two points away from cryo. However, nearly half of doctors expect to continue increasing their overall procedure volume in the first year of PFA availability and add PFA case volume at a level that more than offsets their planned reduction in traditional ablation cases. In the year following FDA approval for Varipulse and Sphere-9 systems, Varipulse wins 10 points of market share, Sphere-9 secures 4 points, and Farapulse holds 16 points of share.”

She went on to write, “In the third year following the first PFA launches, traditional ablation is expected to be used in roughly half of ablation cases (42% RF, 10% cryo), while PFA takes the other half (16% Farapulse, 13% Varipulse, 10% PulseSelect, and 7% Sphere-9.) This matches what we have heard in diligence over the past four years, including an expectation that PFA will quickly become standard of care and that there will be more than one winner in PFA.”