US-based global medical technology company Boston Scientific Corporation (NYSE: BSX) announced on Friday that it has received approval from Pharmaceuticals and Medical Device Agency (PMDA) in Japan for the FARAPULSE Pulsed Field Ablation (PFA) System.
The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation (AF), and is a novel alternative to standard-of-care thermal ablation treatment.
Boston Scientific is expected to commence the OPTION-A clinical trial in Japan, China, Taiwan and Hong Kong in early 2025. The trial is to study the safety and efficacy of concomitant procedures utilising the FARAPULSE PFA System for cardiac ablation and the WATCHMAN FLX Pro Left Atrial Appendage Closure Device.
The company plans to launch the FARAPULSE PFA System in Japan in the coming weeks, following reimbursement approval.
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