Boston Scientific (NYSE: BSX) today shared positive findings from studies for its Farapulse and Watchman FLX offerings.
Farapulse, a pulsed field ablation (PFA) system, provides an option to treat AFib. It received FDA approval in early 2024 and this summer picked up expanded approval.
Watchman FLX, Boston Scientific’s left atrial appendage closure (LAAC) device, which reduces the risk of thromboembolism from the LAA in patients with non-valvular AFib. They reduce stroke risk in such patients who need an alternative to oral anticoagulation therapy. The next-generation FLX devices feature a polymer coating, visualization markers and a broader size matrix. The company says this design helps to treat a wider range of patients.
The company shared its findings at the 2025 European Society of Cardiology (ESC) Congress in Madrid.
Boston Scientific’s Cat Jennings and Kristin LaRocca will share Boston Scientific’s formula for integrating acquired MedTech companies on a panel at DeviceTalks West, Oct. 15–16, 2025 in Santa Clara, California. Register at West.DeviceTalks.com.
For Farapulse, the company shared one-year outcomes in more than 1,100 patients in the FARADISE global registry. Farapulse demonstrated favorable procedural and safety outcomes and clinical effectiveness across ablation strategies and AFib types (paroxysmal and persistent).
The data built on positive 30-day outcomes at HRS 2024, Boston Scientific said. Findings included a 1.5% serious adverse event rate with no reported esophageal fistulas or pulmonary vein stenosis.
For Watchman FLX, a sub-analysis of the OPTION trial remained consistent with previously shared outcomes in 2024. Watchman FLX maintained thromboembolic protection from stroke while delivering significantly reduced bleeding in both high- and low-risk low patients.
Boston Scientific said the data reinforce the device’s role as a safe and effective alternative to long-term anticoagulation, regardless of stroke risk.
Commentary from investigators and Boston Scientific officials
Dr. Prof. Lucas Boersma, electrophysiologist at St. Antonius Hospital, said of FARADISE:
“Demonstrating favorable outcomes in everyday clinical practice related to safety (1.5% rate of serious adverse events and mostly vascular access related), efficiency (less than one-hour procedure) and effectiveness (70%), the one-year FARADISE registry findings demonstrate how modern atrial fibrillation ablation procedures with the Farapulse pentaspline system offer a paradigm shift for electrophysiologists and their patients.”
Dr. Brad Sutton, chief medical officer, AFib Solutions at Boston Scientific
“We were pleased to share late-breaking data at ESC that provided valuable insights from our FARADISE global registry and OPTION trial, respectively highlighting our Farapulse PFA system and Watchman FLX LAAC device for the comprehensive management of patients with atrial fibrillation.”
