The Marlborough, Massachusett–based company announced today that Japan’s Pharmaceuticals and Medical Device Agency has approved Farapulse, which is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation.
Medtronic announced Japanese approval of the competing PulseSelect PFA system in May.
“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,” Nick Spadea-Anello, president of Electrophysiology at Boston Scientific, said in a news release.
“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.”
PFA has generated great excitement in the cardiology space because, unlike the radiofrequency ablation systems out there, it is non-thermal. Its potential advantages versus RF ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it. In contrast, other types of surrounding tissue are injury-resistant to PFA, a factor that could reduce complications.
Boston Scientific announced in January that it won FDA approval for the use of Farapulse in treating drug-refractory, recurrent, symptomatic, paroxysmal AFib. It became the second company to receive FDA approval for a pulsed field ablation (PFA) system that treats AFib after Medtronic.
Other recent Farapulse regulatory wins include the announcement of Chinese approval in July.
Boston Scientific bought Farapulse for nearly $300 million in 2021 — the same year the system secured its CE mark in Europe.
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