Boston Scientific Gains FDA Approval for Farapoint Catheter

Boston Scientific received FDA clearance for its Farapoint pulsed field ablation (PFA) catheter, used as an adjunct in treating persistent atrial fibrillation (AFib). The device delivers linear and focal lesions while preserving surrounding cardiac tissue and integrates with the Faraview software on the Opal HDx mapping system for enhanced visualization.

Clinical data from cavotricuspid isthmus ablation demonstrated safety, effectiveness, and high success in preventing atrial flutter recurrence. Farapoint complements Boston Scientific’s Farapulse system, the leading PFA technology in the U.S. since 2024.

Persistent AFib affects 25% of AFib patients and can lead to stroke, heart failure, and blood clots. The device is also used in “re-do” ablations, about 40% of procedures, potentially increasing revenue per case and maintaining market share.

Farapoint has CE marking in Europe, with limited release scaling up this year. Boston Scientific is also studying its use in re-do procedures and ventricular tachycardia in clinical trials.

20-01-2026