Medtronic has been granted reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its 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 implantation is determined to be the best option.
This approval follows the receipt of MHLW approval of the Shonin in November 2016. The approval is based on data from the CoreValve US pivotal and CE mark Clinical Trials, which demonstrated high rates of survival, low rates of stroke and excellent haemodynamics.
“TAVI 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,” says Yoshiki Sawa, 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 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 the lowest on the market (14Fr equivalent, less than 1/5 inch). The Evolut R system, with its self-expanding nitinol frame, is designed to optimally fit within the native aortic valve, using its supra-annular valve position to help achieve excellent haemodynamic performance.
“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,” adds Shigeru Saito, director of cardiology and catheterisation laboratories at Shonan Kamakura General Hospital in Kamakura, Japan.
The Evolut R is intended to increase conformability and sealing at the annulus. An extended sealing skirt on the 26mm and 29mm valve sizes is intended to further promote valve sealing at the annulus.
The CoreValve system was the first self-expanding TAVI system to be approved in Japan in March of 2015.