Boston Scientific (BSX) said Friday it has received approval for its Farapulse pulsed field ablation system from Japan's Pharmaceuticals and Medical Device Agency.
The Farapulse system is indicated to isolate pulmonary veins to treat paroxysmal atrial fibrillation, the company added.
The system uses non-thermal electrical fields to ablate cardiac tissue associated with atrial fibrillation, Boston Scientific said.
The company intends to roll out the Farapulse system in Japan in the coming weeks.
Boston Scientific also said it anticipates starting the Option-A clinical study in China, Hong Kong, Japan, and Taiwan early next year to evaluate the safety and efficacy of concomitant processes using the Farapulse system for cardiac ablation.
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