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Boston Scientific receives PMDA approval in Japan for FARAPULSE PFA System

Boston Scientific announced it has received Pharmaceuticals and Medical Device Agency approval in Japan for the FARAPULSE Pulsed Field Ablation System. The FARAPULSE PFA System, which is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation, is a novel alternative to standard-of-care thermal ablation treatment. Boston Scientific plans to launch the FARAPULSE PFA System in Japan in the coming weeks, following reimbursement approval.

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