Edwards Sapien 3 TAVR Device Approved in Japan

March 16, 2016—Edwards Lifesciences Corporation announced that the Japanese Ministry of Health, Labor, and Welfare approved the Edwards Sapien 3 transcatheter aortic valve replacement device for the treatment of patients with severe, symptomatic aortic stenosis.     

Edwards anticipates reimbursement approval from the Japanese Ministry of Health, Labor, and Welfare in the second quarter, to be followed immediately by a commercial launch in Japan. The company expects to be fully launched in Japan by the end of the year. In October 2013, the Sapien XT valve was the first transcatheter aortic valve replacement device introduced by Edwards in Japan.

According to Edwards Lifesciences, the Sapien 3 valve is approved in 20-, 23-, 26-, and 29-mm sizes. The device has an outer skirt providing a seal to address paravalvular leak. The valve can be delivered via a 14-F transfemoral eSheath introducer.

The Sapien 3 valve received European CE Mark approval in January 2014 and the US Food and Drug Administration approved the device in June 2015.