Boston Scientific’s FARAPULSE™ Pulsed Field Ablation (PFA) System has reached a pivotal milestone with FDA approval for expanded labeling, now including use in patients with drug-refractory, symptomatic persistent atrial fibrillation (AF). This expansion underscores the system’s innovation as a non-thermal ablation solution that uses pulsed electric fields to selectively ablate cardiac tissue. Unlike conventional thermal techniques such as radiofrequency or cryoablation, FARAPULSE minimizes the risk of collateral damage to surrounding structures like the esophagus and pulmonary veins, making it a safer alternative in complex arrhythmia cases.

With persistent AF affecting millions globally, treatment gaps remain for patients whose symptoms persist despite antiarrhythmic drug therapy. The FARAPULSE system enables physicians to treat these patients using a more efficient and targeted approach. Clinical findings from the ADVANTAGE AF trial demonstrated strong efficacy and safety—achieving an 85.3% symptomatic AF recurrence-free rate overall, and up to 91.4% when performed by experienced operators. The catheter’s compatibility with advanced navigation systems and its refined workflow further contribute to procedural consistency and reduced complexity, which are critical for adoption in high-volume electrophysiology practices.

This regulatory advancement marks a strategic leap for Boston Scientific, reinforcing its leadership in pulsed field ablation and its commitment to transforming AF treatment globally. With approvals anticipated in Europe, Japan, and China, and ongoing clinical studies like ReMATCH evaluating expanded use cases, FARAPULSE is poised to redefine ablation standards across the arrhythmia care continuum. The approval brings not only an expanded tool for electrophysiologists but also renewed hope for patients living with persistent AF, offering a safer, more effective pathway to long-term symptom relief.