Boston Scientific has announced receipt of Pharmaceuticals and Medical Device Agency (PMDA) approval in Japan for the Farapulse pulsed field ablation (PFA) system. The Farapulse PFA system—which is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation (AF)—is a novel alternative to standard-of-care thermal ablation treatment.
“Clinical evidence and extensive real-world use have demonstrated the Farapulse PFA system to be an efficient and more predictable procedure than traditional thermal ablation, and a proven safe technology,” said Kazuhiro Satomi (Tokyo Medical University Hospital, Tokyo, Japan). “This technology has the potential to rapidly advance clinical practice and improve outcomes, and is anticipated to further expand the range of treatment options for AF that can be tailored to each patient’s condition.”
Unlike traditional thermal ablation, which uses extreme heat or cold to ablate cardiac tissue associated with AF, the Farapulse PFA system uses non-thermal electrical fields that avoid damage to surrounding structures—as detailed in a recent Boston Scientific press release.
“The Farapulse PFA system is the most clinically studied PFA system, and its use in treating more than 125,000 patients globally to date continues to reinforce its strong safety, efficacy and efficiency profile,” said Nick Spadea-Anello, president of Electrophysiology at Boston Scientific. “The rapid adoption of the Farapulse PFA system, which is now approved in more than 65 countries, indicates a paradigm shift for the treatment of paroxysmal AF—one that has clinical benefits to both physicians and patients—and we look forward to bringing this differentiated technology to Japan.”
Adding to its robust body of clinical evidence on the Farapulse PFA system, Boston Scientific has said it expects to initiate the OPTION-A clinical trial in Japan, China, Taiwan and Hong Kong in early 2025. This study will evaluate the safety and efficacy of concomitant procedures using the Farapulse PFA system for cardiac ablation and the Watchman FLX Pro left atrial appendage closure device.
Following its recent reimbursement approval, the company also plans to launch the Farapulse PFA system in Japan “in the coming weeks”.
