Boston Scientific's FARAPULSE Pulsed Field Ablation System Gets Japanese Regulatory Approval

(RTTNews) - Boston Scientific Corp. (BSX) announced Friday that it has received Pharmaceuticals and Medical Device Agency approval in Japan for the FARAPULSE Pulsed Field Ablation or PFA System.

The company said it plans to launch the FARAPULSE PFA System, which is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation or AF, in Japan in the coming weeks, following reimbursement approval.

The FARAPULSE PFA System is a novel alternative to standard-of-care thermal ablation treatment for AF, which can lead to increased risk of death, stroke and heart failure and affects more than one million people in Japan.

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.

Nick Spadea-Anello, president, Electrophysiology, Boston Scientific, said, "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. 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."

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