Medtronic received reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the CoreValve(TM) Evolut(TM) R System for aortic stenosis (AS) patients unable to have surgery.
It is also for those whose best treatment option is the transcatheter aortic valve implantation (TAVI).
“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,” said Yoshiki Sawa, M.D., professor in the Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine in Osaka, Japan. “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.”
The system includes the EnVeo(TM) R Delivery System featuring an Enveo R InLine(TM) Sheath that Medtronic says, “reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch).”
It also includes the CoreValve Evolut R transcatheter valve. The Evolut R System has a self-expanding nitinol frame and fits within the native aortic valve.
According to Medtronic, The CoreValve System, the Evolut R is proposed to increase sealing and conformability on the 26mm and 29mm valve sizes at the annulus.
“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,” said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, which is part of the Cardiac and Vascular Group at Medtronic. “We look forward to introducing this next-generation, recapturable technology to indicated patients in Japan.”