Biosense Webster, part of Johnson & Johnson MedTech, announced approval from the Japanese Ministry of Health, Labour and Welfare, or MHLW, for the VARIPULSE Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation, or AFib, using pulsed field ablation, or PFA. This is the first regulatory approval for “the first-of-its-kind, fully-integrated PFA system with a simple and reproducible workflow,” making it the “first and only PFA system approved in Japan,” J&J stated.
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