FDAnews
www.fdanews.com/articles/179495-medtronics-nabs-japan-approval-corevalve-evolut-r-heart-valve

Medtronic’s Nabs Japan Approval CoreValve Evolut R Heart Valve

December 1, 2016

Medtronic won reimbursement and Shonin approval from the Japanese Ministry of Health, Labor & Welfare for its CoreValve Evolut R transcatheter aortic valve replacement.

The device treats patients with aortic stenosis, a condition where the aortic valve narrows thereby limiting blood flow from the aorta to the rest of the body.

The approvals include its Enveo R delivery system. — Cynthia Jessup

View today's stories