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.