- Boston Scientific (BSX, Financial) receives FDA approval for expanded use of FARAPULSE™ PFA System to treat persistent atrial fibrillation.
- Clinical trials showed an 85.3% symptomatic AF recurrence-free rate, improving to 91.4% among experienced physicians.
- Boston Scientific plans for CE mark approval and regulatory clearances in Japan and China, and has initiated the ReMATCH IDE trial.
Boston Scientific (BSX) has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval to expand the labeling of its FARAPULSE™ Pulsed Field Ablation (PFA) System. This approval now includes the treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF), a condition where the heart's rhythm is abnormal for at least seven days.
The expansion is bolstered by comprehensive clinical evidence from the ADVANTAGE AF trial, which reported an impressive 85.3% symptomatic AF recurrence-free rate. Notably, the success rate increased to 91.4% when procedures were performed by more experienced physicians. The trial included 260 patients across 43 sites globally, without any reported major complications such as stroke or pulmonary vein stenosis.
Boston Scientific is positioning itself for further market expansion by seeking CE mark approval and regulatory clearances in Japan and China. Concurrently, the company has launched the ReMATCH IDE clinical trial to evaluate the safety and effectiveness of the FARAWAVE™ PFA Catheter in 375 patients across 40 centers in the U.S. and Asia, targeting those who have had recurrences after previous ablation procedures.
The FARAPULSE system targets the persistent AF market segment, which accounts for a significant portion of the estimated 59 million individuals globally affected by atrial fibrillation. This development represents a substantial market opportunity for Boston Scientific, enhancing their competitive edge in the electrophysiology landscape.
