Boston Scientific’s Farapulse PFA system is poised for FDA approval, analysts say

Boston Scientific’s Farapulse pulsed-field ablation (PFA) system likely hit its primary endpoints, according to Needham analysts who say that means the technology is poised for FDA approval.

Boston Scientific has already said it expects FDA approval of Farapulse next year, but has not yet shared results from its ADVENT pivotal trial.

That data is set for release on Aug. 27 at the 2023 European Society of Cardiology (ESC) Congress. The device developer started that trial in March 2021 and stopped enrolling patients in June 2022.

Based on the trial’s adaptive design with a varying number of possible patients — 350, 450, 550, 650 or 750 — and the timing of enrollment, the Needham analysts say they suspect Boston Scientific was able to end the trial before enrolling the maximum 750 patients.

“Assuming that this is correct and since [Boston Scientific] has not indicated that the trial was stopped for futility, we think it means that the trial probably met its primary endpoints given its adaptive design,” Needham analysts Mike Matson, David Saxon and Joseph Conway said in a note to subscribers today.

They said the FDA could approve Farapulse in the second half of 2024. Boston Scientific is already selling Farapulse in Europe; the technology had CE mark approval before Boston Scientific acquired it in 2021.

The ADVENT trial compared Farapulse’s ablation therapy for treating patients with paroxysmal atrial fibrillation (AFib) without anti-arrhythmic drugs against radiofrequency (RF) ablation and cryoballoon ablation.

Reached for comment today, a Boston Scientific spokeswoman would only say the company is looking forward to presenting the results and will discuss the findings after. But Boston Scientific executives expressed enthusiasm on the company’s latest earnings call last month.

“We’re really proud of the rigor of that trial,” Boston Scientific SVP and Global Chief Medical Officer Kenneth Stein said. “It is the first randomized trial in this space comparing pulsed-field ablation with the Farapulse system against thermal ablation with RF and cryo. It’s an incredibly rigorous design in terms of the endpoints and the monitoring, and we look forward to sharing those results in public.”

The randomized controlled trial also evaluated secondary endpoints for safety and efficacy superiority.

“While we do not expect superiority, we think achieving it would be significantly positive for Farapulse,” the analysts said.

Earlier this year, Boston Scientific shared real-world data from its European registry showing positive results for Farapulse.

Boston Scientific is already ramping up Farapulse manufacturing, announcing Minnesota as the location of a second pulse generator site last month.

“Farapulse is very exciting for us,” Boston Scientific Chari and CEO Mike Mahoney said on the earnings call. “We’ve been investing for quite a while post-acquisition to build up manufacturing capabilities, which is the most important thing we could do to meet the demand that we’re seeing in Europe and in certain countries in Asia-Pac.”

The FDA has not yet approved any PFA systems, but the Needham analysts expect Medtronic’s Affera system to cross the finish line first.

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