The data comes just days after CEO Mike Mahoney singled out the two platforms as key growth drivers for the company moving forward. Speaking at the JP Morgan Healthcare Conference, Mahoney talked about how they could spur growth — including in conjunction with one another.
Today, Boston Scientific announced data from the ADVANTAGE AF and OPTION trials supporting Farapulse and Watchman FLX, respectively. Investigators presented findings at the 30th annual AFib Symposium in Boston.
Farapulse, a pulsed-field ablation (PFA) system for treating AFib, received a much-anticipated FDA approval last year. Mahoney said that, with Farapulse, Boston Scientific “disrupted and transformed a hot, large market” in electrophysiology. With Watchman FLX, a left atrial appendage closure (LAAC) device, Mahoney said the company essentially “created this [LAAC] market over many years.”
Boston Scientific reported that Farapulse met its primary safety and efficacy endpoints. Watchman FLX delivered consistent outcomes in concomitant and sequential subgroups.
More on the performance from the Boston Scientific Farapulse system
ADVANTAGE AF looked at Farapulse for both pulmonary vein isolation (PVI) and posterior wall ablation (PWA). It evaluated patients with persistent AFib with an irregular or rapid heartbteat lasting longer than seven days. This represents 25% of all AFib cases, the company says.
Farapulse met its primary safety endpoint, defined as serious adverse events related to either the use of an ablation catheter or the ablation procedure within seven days of the primary procedure and pulmonary vein stenosis or atrio-esophageal fistula out to 12 months. Boston Scientific reported a 2.3% event rate.
Additionally, the system met the primary effectiveness endpoint, defined as freedom from AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion and use of a new or escalated dose of Class I/III AAD or amiodarone. That rate came in at 63.5%.
Investigators reported a symptomatic AF recurrence-free rate of 85.3%. Physicians that performed three or more procedures in the trial reported an even higher rate at 91.8%. Boston Scientific reports no incidences of stroke, pulmonary vein stenosis, atrio-esophageal fistula or major access complications.
Highlights from the OPTION sub-analysis
OPTION, a randomized head-to-head study, compares Watchman technology to direct oral anticoagulants (95% DOACs, 5% warfarin) after cardiac ablation. Data presented today fell in line with previously shared safety and efficacy data presented at the American Heart Association’s Scientific Sessions 2024 and simultaneously published in The New England Journal of Medicine.
Findings from a new, prespecified analysis came from 1,600 patients with AFib. Those patients underwent a device implantation either concomitantly or sequentially (90-180 days post-ablation).
Concomitant LAAC with Watchman FLX post-ablation demonstrated a statistically significant reduction (44%) in non-procedural bleeding outcomes compared to OAC at 36 months. Those outcomes came in at 8% and 13%, respectively. This method produced similar efficacy outcomes (7% vs. 6.7%) with regard to all-cause death, stroke or systemic embolism.
Sequential LAAC produced a statistically significant (62%) reduction in non-procedural bleeding outcomes compared to OAC at 36 months. Those outcomes came in at 8.8% and 21.5%, respectively. Again, Boston Scientific reported similar efficacy outcomes (4.2% vs. 5.3%).
Data highlighted similar stroke protection with Watchman FLX compared to OAC, irrespective of the method of implantation. The concomitant group produced 2.3% (LAAC) and 2.5% (OAC) rates of all stroke. The sequential group saw 1.1% vs. 1.6% in the respective groups.
The analysts’ take
BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang believe the data supports anticipated label expansions for the technologies.
Specifically, they say the ADVANTAGE AF results should support expansion into persistent AFib later this year. Boston Scientific anticipates a Watchman label update in the second half of 2025, too.
The analysts highlighted the importance of experience with Farapulse, as made evident by the increased success for physicians using the system three or more times.
Meanwhile, both platforms coming into play with concomitant procedures could prove fruitful for Boston Scientific, they said.
“We think Watchman LAAC with ablation (often PFA) performed concomitantly will continue to gain popularity, supported by a recent reimbursement code,” the analysts wrote. “We believe that positive outcomes from the trial, coupled with the new DRG, may help support the economic value proposition of conducting concomitant LAAC and PFA procedures using Watchman.”
