Japan’s regulatory body has approved Edwards Lifesciences’ Sapien XT valve for surgical aortic valve replacement.
A clinical trial to assess the Sapien XT valve in Japan was conducted at Osaka University Hospital in Osaka, Sakakibara Heart Institute in Tokyo and Kurashiki Central Hospital in Okayama. Irvine, Calif.-based Edwards Lifesciences said it is awaiting reimbursement approval from the Japanese Ministry of Health, Labor and Welfare before fully launching the valve.
The valve was commercially launched in Europe in 2010. It remains an investigational device in the U.S.