Boston Scientific(BSX) Prnewswire·2025-01-16 22:33Core Insights - Boston Scientific Corporation announced positive data from the ADVANTAGE AF clinical trial, demonstrating safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation System for treating drug-resistant, symptomatic, persistent atrial fibrillation [1][3] - A sub-analysis from the OPTION clinical trial highlighted consistent safety and efficacy outcomes of the WATCHMAN FLX™ Left Atrial Appendage Closure Device post cardiac ablation [1][4] ADVANTAGE AF Clinical Study - The FARAPULSE PFA System is currently approved for pulmonary vein isolation in patients with paroxysmal atrial fibrillation, while the ADVANTAGE AF study evaluated its use for both pulmonary vein isolation and posterior wall ablation in patients with persistent atrial fibrillation, which accounts for 25% of all AF cases [2] - The study included 260 patients across 43 global sites who were intolerant to at least one Class I/III anti-arrhythmic drug [2] Key Findings from ADVANTAGE AF Study - Through 12 months, the study reported positive safety and efficacy outcomes, with many patients able to discontinue anti-arrhythmic drugs and experience improved quality of life [3] - The findings support a shift towards PFA as a treatment for patients with persistent and complex forms of atrial fibrillation [3] OPTION Trial Sub-Analysis - The OPTION trial sub-analysis included 1,600 patients with atrial fibrillation who underwent device implantation either concomitantly or sequentially, demonstrating a primary safety endpoint event rate of 2.3% and a primary effectiveness endpoint of 63.5% freedom from atrial fibrillation [4][5] - The symptomatic AF recurrence-free rate was reported at 85.3%, increasing to 91.8% among physicians performing three or more procedures [5] Additional Findings from OPTION Trial - Concomitant LAAC with the WATCHMAN FLX device showed a 44% reduction in non-procedural bleeding outcomes compared to oral anticoagulants at 36 months [6] - Sequential LAAC demonstrated a 62% reduction in non-procedural bleeding outcomes compared to oral anticoagulants at 36 months [7] - Stroke protection rates were similar between the WATCHMAN FLX device and oral anticoagulants, regardless of implantation timing [7] Company Overview - Boston Scientific is a global leader in medical technology, providing innovative solutions to improve patient health and reduce healthcare costs [8]