Boston Scientific receives Japanese regulatory approval for FARAPULSE pulsed field ablation system

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Boston Scientific announced it has received 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.

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.

"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, M.D., Ph.D., professor, Department of Cardiology and director, Heart Rhythm Center, Tokyo Medical University Hospital. "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."

Boston Scientific expects to initiate the OPTION-A clinical trial in Japan, China, Taiwan and Hong Kong in early 2025 to study 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.

Boston Scientific plans to launch the FARAPULSE PFA System in Japan in the coming weeks, following reimbursement approval.