FDA Expands Boston Scientific’s Farapulse Approval for Persistent AFib

Boston Scientific has received FDA approval to use its Farapulse pulsed field ablation (PFA) system in patients with persistent atrial fibrillation (AFib)—a form lasting over seven days and resistant to drug therapy. Previously approved for paroxysmal AFib, this expansion follows positive results from the Advantage AF trial.

Farapulse, including the Farawave and Farawave Nav catheters, offers a nonthermal ablation method that may improve safety over traditional heat or cold-based treatments. The system now covers pulmonary vein and posterior wall ablation for persistent AFib.

Persistent AFib accounts for roughly 25% of all cases. Farapulse has driven rapid growth in Boston Scientific’s electrophysiology division. The company is also running a clinical trial in the U.S. and Asia to assess its use in patients needing repeat ablations. European (CE mark), Japanese, and Chinese approvals are expected soon.

09-07-2025