Medtronic (NYSE:MDT) said today that it won reimbursement and Shonin approval from the Japanese Ministry of Health, Labor & Welfare (MHLW) for its CoreValve Evolut R transcatheter aortic valve replacement.
Fridley, Minn.-based Medtronic, which won pre-market approval from the FDA for the CoreValve Evolut R in June 2015, said the Japanese approvals include its Enveo R delivery system.
“[Transcatheter aortic valve implantation] 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,” Dr. Yoshiki Sawa, of the Osaka University Graduate School of Medicine, said in prepared remarks. “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.”
“Heart teams made up of cardiac surgeons and interventional cardiologists in Japan are making important TAVI 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,” added Dr. Shigeru Saito of Kamakura’s Shonan Kamakura General Hospital.
“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,” heart valve therapies general manager Rhonda Robb said. “We look forward to introducing this next-generation, recapturable technology to indicated patients in Japan.”