AtriCure has announced that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its cryoICE platform and CRYO2 cryoablation probe. The devices are used for surgical treatment of cardiac arrhythmias.
“We are pleased to have this approval in hand, and to be able to bring our cryoablation products to the Japanese market,” says Mike Carrel, president and CEO of AtriCure. “This new approval will augment our offerings in the Japanese market and offer a leading solution to cardiac surgeons and the Japanese patients for the treatment of atrial fibrillation.”
AtriCure announced that the company’s distributor in Japan, Century Medical Inc, worked closely with AtriCure to secure approval. Product will be immediately available for sale as soon as the reimbursement application is completed, which is expected in the fourth quarter, AtriCure announced in a press release.
“Japanese surgeons have been waiting a long time for this moment. We believe many patients will benefit from this technology and look forward to bringing it to market,” says Takahiko Motani, president and CEO of Century Medical Inc.