At the 2025 European Society of Cardiology (ESC) congress (29 August–1 September, Madrid, Spain), Boston Scientific shared two late-breaking presentations pertaining to its Farapulse pulsed field ablation (PFA) system and Watchman FLX left atrial appendage closure (LAAC) device.
New findings from the FARADISE global registry including one-year outcomes in more than 1,100 patients treated with the Farapulse PFA system demonstrated favourable procedural and safety outcomes, and clinical effectiveness, across different ablation strategies and atrial fibrillation (AF) types—both paroxysmal and persistent.
According to Boston Scientific, these data also demonstrated a 1.5% serious adverse event rate, with no reported oesophageal fistulas or pulmonary vein stenoses, building on positive 30-day outcomes presented at last year’s Heart Rhythm Society (HRS) annual meeting (16–19 May 2024, Boston, USA).
The results revealed at ESC 2025 were simultaneously published in EP Europace. Three-year outcomes from the ongoing, real-world FARADISE registry are anticipated in 2027.
In addition, as per a sub-analysis of the OPTION trial, the Watchman FLX LAAC device maintained thromboembolic protection from stroke while delivering significantly reduced bleeding in both high- and low-risk patients—findings that are consistent with primary outcomes first presented in 2024.
These data reinforce the device’s role as a safe and effective alternative to long-term anticoagulation, regardless of stroke risk (high=CHA2DS2-VASc score ≥4; low=CHA2DS2-VASc score ≤3), Boston Scientific claims.
“The Farapulse PFA system is a PFA leader, having treated well over 200,000 patients globally. These latest data further solidify our clinical leadership, and the safety and efficacy of this transformative technology, which we were pleased to present at this year’s congress,” said Brad Sutton, chief medical officer for AF Solutions at Boston Scientific. “In addition, the OPTION trial sub-analysis reinforces the role of the Watchman FLX device as a safe and effective alternative to long-term anticoagulation after AF ablation, regardless of a patient’s stroke risk. Together, these data reflect our dedication to generating robust clinical evidence and continuously refining our solutions to make a meaningful difference in patient outcomes worldwide.”
