FDA approves Boston Scientific’s Farapoint PFA catheter
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Farapoint pulsed field ablation (PFA) catheter, adding another device to the company’s electrophysiology portfolio.
The Farapoint PFA catheter was designed to be used together with Boston Scientific’s Farapulse PFA platform, which already secured FDA approval for the treatment of both paroxysmal and persistent atrial fibrillation (AFib). Farapoint was specifically approved to be used for cavotricuspid isthmus (CTI) ablation, providing additional value not seen with Boston Scientific’s other PFA catheters, the Farawave and Farawave NAV.
“Farapoint PFA catheter approval expands the Farapulse PFA platform with a safe, effective tool that enables more confident and controlled therapy delivery,” Nick Spadea-Anello, executive vice president and president of AFib solutions for Boston Scientific, said in a statement to the media. “The first and only focal catheter designed and optimized for PFA, this device will provide further predictability for physicians during certain PFA procedures and represents another meaningful advancement for patients being treated for AFib.”
Spadea-Anello shared additional details on social media, noting that the Farapoint PFA catheter and Faraview software module can be used together on Boston Scientific’s Opal HDx mapping system to gain an enhanced view of both the catheter and the lesion being targeted. He also noted that Farapoint device already secured CE mark approval.
Additional research still underway on Boston Scientific's PFA technologies
In 2025, Boston Scientific officially launched the ReMATCH IDE clinical trial to track the safety and effectiveness of using its Farawave PFA catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AFib. The study is expected to enroll approximately 375 patients in the United States and Asia who have already undergone a prior ablation procedure.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.