Boston Scientific Corp.‘s Farapoint, its latest pulsed field ablation (PFA) catheter, received U.S. FDA approval for use as an adjunctive device when treating persistent atrial fibrillation that requires cavotricuspid isthmus ablation, CEO Mike Mahoney reported at the J.P. Morgan Healthcare Conference in San Francisco.
The newest member of the popular Farapulse family of PFA catheters provides a focal point option for creation of straight line or focal lesions, complementing the larger, single-shot Farawave catheter that has dominated the PFA market since its U.S. approval in early 2024.
“Farapoint PFA catheter approval expands the Farapulse PFA platform with a safe, effective tool that enables more confident and controlled therapy delivery,” Nick Spadea-Anello, executive vice president and president, Atrial Fibrillation Solutions, Boston Scientific, told BioWorld. “The first and only focal catheter designed and optimized for PFA, this device will provide further predictability for physicians during certain PFA procedures and represents another meaningful advancement for patients being treated for AF.”
The approval came a few weeks later than the end of year time frame the company anticipated, but the short delay is unlikely to materially affect financial projections. Farapoint received CE mark in November for cavotricuspid isthmus (CTI) ablation, specifically in atrial flutter (AFl)
The Farapoint catheter delivers focal and linear-shaped lesions within 2.5 seconds per ablation, Marlborough, Mass.-based Boston Scientific said. Full integration with the Faraview software module on the Opal HDx mapping system supports catheter and lesion visualization to give operators the confidence to precisely deliver PFA lesions even in complex anatomies, the company added. The catheter creates controlled lesions with depths of up to 7 mm to achieve conduction block across complex anatomies and through scar tissue while protecting surrounding tissue.
The approval brings the potential benefits of PFA – including rapid, tissue-selective ablation and procedural efficiency – to patients with atrial flutter as well as to the 25% of patients with atrial fibrillation who have the persistent form that continues for more than seven days. Atrial fibrillation (AF) increases the risk of stroke five-fold and significantly elevates the risk of heart failure and death.
The focal point catheter also addresses the re-do procedure market, which represent about 40% of AF ablation procedures initially performed using thermal ablation such as radio frequency or cryotherapy. Boston Scientific is also evaluating the use of Farapoint for ventricular tachycardia.
Clinical data supporting the FDA approval came from phase II of the ADVANTAGE AF trial, which evaluated the Farapulse system and Farapoint catheter as adjunctive therapy for persistent atrial fibrillation and atrial flutter. The study found that 97.9% of 141 patients who underwent CTI ablation with the Farapoint catheter had no recurrence of AFL, a rate Boston Scientific said compares closely with the 98% efficacy observed with radiofrequency ablation in phase I.
Safety profiles were likewise comparable at 90 days, with adverse events of 2.1% for Farapoint vs. 2% for radiofrequency ablation, and the company reported no coronary artery spasms when prophylactic nitroglycerin was administered during CTI applications.
A sub-analysis of the trial suggested the Farapoint catheter offered greater predictability in CTI applications and shorter overall procedure times compared with radiofrequency ablation, findings the company said could translate into more consistent workflows and procedural efficiencies in real-world practice.
The line ablations enabled by the device are also performed in “re-do” afib procedures, which Stifel estimated make up about 40% of all AFib ablation procedures.
At the J.P. Morgan Healthcare Conference on Jan. 13, Mahoney noted that the PFA “market is undoubtedly the fastest-growing market in med tech. In ’25, the market was well in this 20% growth range, and we predict a very, very healthy market, a minimum of 15% plus over the next three years.” He attributed continued growth in the field to the company’s rapid expansion of its mapping footprint, which was nominal in 2024.
“Just to reiterate the point, this is a market that will continue growing double digits, right, certainly over our long-range plan and beyond,” added Boston Scientific Chief Medical Officer Ken Stein. “AF, an incredibly common arrhythmia – 10.5 million Americans have afib – probably about 60 million people across the globe. AF ablation is still incredibly underpenetrated, sort of high teens probably at this point in the U.S. for paroxysmal afib, high single digits for persistent. So there’s just a lot of runway for continued growth and PFA and Farapulse in particular, is part of what’s driven that.”
The approval could help Boston Scientific generate greater revenues per procedure and further build on its electrophysiology market share, which has also been boosted by concomitant procedures with PFA and the Watchman left atrial appendage occlusion device.
Stein also noted that the company has plenty of room for substantial continued expansion in related segments and specifically mentioned that Boston Scientific is also developing an intracardiac echo catheter. “That’s a $1 billion market that we haven’t participated in at all.”
