Medtronic has secured reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the CoreValve Evolut R System for aortic stenosis (AS) patients unable to have surgery.
It is also indicated for those whose best treatment option is the transcatheter aortic valve implantation (TAVI).
CoreValve’s latest approval follows the Shonin approval from the MHLW in November.
The approval is based on data from the CoreValve US pivotal and CE mark clinical trials that showed high rates of survival, low rates of stroke and better hemodynamics.
The system, which features CoreValve Evolut R transcatheter valve and EnVeo delivery system, includes self-expanding nitinol frame that will allow to optimally fit within the native aortic valve.
Evolut R will increase conformability and sealing at the annulus. Its extended sealing skirt on the 26mm and 29mm valve sizes will further promote valve sealing at the annulus.
CoreValve system is the first self-expanding TAVI system that secured approval in Japan in March 2015.
Medtronic cardiac and vascular group’s heart valve therapies business general manager and vice president Rhonda Robb said: "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."