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FDA Update: Agency Approves FARAPULSE Pulsed Field Ablation System

The U.S. Food and Drug Administration (FDA) has approved the FARAPULSE Pulsed Field Ablation System for isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (AFib), according to a Boston Scientific press release.

Different from traditional ablation procedures that use extreme temperatures, the FARAPULSE Pulsed Field Ablation System uses selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding areas.

The agency granted approval following positive 12-month results from the ADVENT trial, which found that therapy with the device was as safe and effective as thermal ablation. Additional data from the MANIFEST-17H registry, capturing over 17,000 patients, demonstrated continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury.

Ongoing and future trials will investigate the safety and effectiveness of the system in treating patients with drug-refractory, symptomatic, persistent AFib, use of the system as a first-line treatment for persistent AFib, and adjunctive use of the FARAPOINT Pulsed Field Ablation Catheter for cavotricuspid isthmus ablations.

Clinical Topics: Arrhythmias and Clinical EP, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Atrial Fibrillation, ACC Advocacy, United States Food and Drug Administration


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