Boston Scientific Receives FDA Approval for Expanded Use of FARAPULSE™ Pulsed Field Ablation System in Treating Persistent Atrial Fibrillation

Reuters
07 Jul
Boston Scientific Receives FDA Approval for Expanded Use of FARAPULSE™ Pulsed Field Ablation System in Treating Persistent Atrial Fibrillation

Boston Scientific Corporation has announced that it received U.S. Food and Drug Administration (FDA) approval for expanded labeling of its FARAPULSE™ Pulsed Field Ablation (PFA) System. The updated labeling now includes approval for the system's use in pulmonary vein and posterior wall ablation for patients with persistent atrial fibrillation. This approval is backed by clinical evidence from the ADVANTAGE AF clinical trial, which demonstrated significant safety and effectiveness. The company plans further studies to expand its application in treating complex arrhythmias. Boston Scientific is also anticipating regulatory approvals in Europe, Japan, and China in the near future.

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