The U.S. Food and Drug Administration (FDA), has granted approval to Boston Scientific for its FARAPULSE Pulsed Field Ablation System. A company statement reported that its PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.
Boston Scientific has received approval for the Farapulse Pulsed Field Ablation system for treatment of drug-refractory, recurrent paroxysmal atrial fibrillation.