On December 1, 2016, Medtronic (MDT) announced the reimbursement approval and launch of its CoreValve Evolut R System in Japan.
The CoreValve Evolut R System is a repositionable heart valve that improves positioning accuracy and control during deployment. It’s used for treating patients with aortic stenosis, a condition in which blood flow is restricted due to the narrowing of the aortic valve.
To date, the system has been implanted in more than 120,000 patients around the world. The CoreValve System was approved in Japan in March 2015 and was the first self-expanding TAVI (transcatheter aortic valve implantation) system approved in the country.
Some of the competing TAVI products in the United States are being developed by Edwards Lifesciences (EW), St. Jude Medical (STJ), and Boston Scientific (BSX). The Vanguard Total Stock Market ETF (VTI) holds ~0.44% of its total holdings in MDT.
Approval study and product benefits
The device’s approval in Japan is based on data from US and CE Mark clinical trials. According to Yoshiki Sawa, MD, a professor in the Department of Cardiovascular Surgery at the Osaka University Graduate School of Medicine in Osaka, Japan, “TAVI continues to grow as an established treatment for inoperable AS 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. 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 TAVI systems.”
According to Rhonda Robb, vice president and general manager of the Heart Valve Therapies business in Medtronic’s Cardiac & Vascular Group segment, “This approval stems from our global commitment to building a market-leading innovation pipeline in the transcatheter space, and we look forward to supporting Japanese heart teams as they look to next-generation technologies to improve valve performance for a broad range of patients. We look forward to introducing this next-generation, recapturable technology to indicated patients in Japan.”
Next, we’ll discuss Medtronic’s recent dividend announcement.