Edwards' Sapien XT Transcatheter Valve Replacement Device Approved in Japan

June 24, 2013—Edwards Lifesciences (Irvine, CA) announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards Sapien XT transcatheter aortic heart valve, which can be delivered transfemorally or transapically. The Sapien XT's bovine pericardial tissue leaflets are based on Edwards's surgical heart valves.

The company expects to obtain reimbursement approval from MHLW by year's end, and will initiate a full launch in Japan immediately thereafter.

According to the company, the clinical study of the Edwards Sapien XT valve in Japan was conducted at Osaka University Hospital in Osaka, Sakakibara Heart Institute in Tokyo, and Kurashiki Central Hospital in Okayama. Additionally, the valve has been studied in the treatment of thousands of patients in both commercial and clinical trial environments. In Europe, it was launched commercially in 2010. In the United States, the Sapien XT valve is an investigational device being studied as part of a randomized, pivotal clinical trial and is not commercially available, advised Edwards Lifesciences.