Medtronic Announces Reimbursement Approval and Launch of CoreValve Evolut R TAVR System in Japan

December 1, 2016—Medtronic plc announced it has received reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the recapturable, self-expanding transcatheter CoreValve Evolut R system for patients with severe aortic stenosis unable to undergo surgery and for whom treatment with transcatheter aortic valve replacement (TAVR) is determined to be the best option. This approval follows the Shonin regulatory approval from the MHLW that the company received in November.

According to Medtronic, Japanese approval is based on data from the CoreValve United States pivotal trial and the European CE Mark clinical trial, which demonstrated high rates of survival, low rates of stroke, and excellent hemodynamics.

The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R delivery system, which features an Enveo R InLine sheath that significantly reduces the profile to 14-F equivalent. The Evolut R system has a self-expanding nitinol frame and is designed to fit within the native aortic valve, using its supra-annular valve position to help achieve hemodynamic performance.

In Medtronic's press release, Yoshiki Sawa, MD, commented, "TAVR continues to grow as an established treatment for inoperable aortic stenosis patients in Japan and we are excited to have a next-generation, self-expanding option, as the Evolut R system has demonstrated exceptional clinical results in studies globally." Prof. Sawa continued, "Clinical data show the advancement of recapturability with Evolut R gives physicians more confidence during the procedure, providing different advantages not currently available in other TAVR systems." Prof. Sawa is Professor in the Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine in Osaka, Japan.

Shigeru Saito, MD, added, "Heart teams made up of cardiac surgeons and interventional cardiologists in Japan are making important TAVR treatment decisions for patients who may benefit from this less invasive valve replacement procedure, and now having the option to recapturable and reposition will only help to improve patient outcomes." Dr. Saito is Director of Cardiology and Catheterization Laboratories at Shonan Kamakura General Hospital in Kamakura, Japan.