Edwards Lifesciences Secures Approval for SAPIEN 3 Valve in Japan

The Japanese Ministry of Health, Labor and Welfare has granted approval to Edwards Lifesciences’ SAPIEN 3 transcatheter heart valve for the treatment of severe symptomatic aortic stenosis.

The device is approved in 20-, 23-, 26 and 29-mm sizes and features an outer skirt seal to prevent paravalvular leak.

The valve snagged commercial approval in the U.S. in June 2015 and in Europe in January 2014. A full product launch is expected toward the end of the year. — Anisa Jibrell