Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System

Core Viewpoint - Boston Scientific Corporation has received FDA approval to expand the use of the FARAPULSE Pulsed Field Ablation (PFA) System for treating drug refractory, symptomatic persistent atrial fibrillation (AF) [1][2]. Group 1: Product Approval and Impact - The FARAPULSE PFA System is now approved for pulmonary vein and posterior wall ablation in patients with persistent AF, a condition affecting an estimated 59 million people globally [1][2]. - The updated instructions for use (IFU) now include the FARAWAVE PFA Catheter and FARAWAVE NAV PFA Catheter for treating patients with persistent AF [2]. Group 2: Clinical Evidence and Trial Results - The FDA approval was supported by clinical evidence from the ADVANTAGE AF clinical trial, which met primary safety and effectiveness endpoints, showing an 85.3% symptomatic AF recurrence-free rate among 260 patients [3]. - Among physicians performing three or more procedures, the symptomatic recurrence-free rate increased to 91.4% [3]. Group 3: Future Developments - Boston Scientific anticipates obtaining CE mark and approvals in Japan and China in the coming months [4]. - The company has initiated the ReMATCH IDE clinical trial to study the safety and effectiveness of the FARAWAVE PFA Catheter in patients with persistent AF who have previously undergone ablation [4].