Medical technology firm Medtronic has received Japanese regulatory approval for its self-expanding transcatheter, CoreValve system, to treat severe aortic stenosis (AS).
The approval was based on data from the CoreValve US pivotal trials and Medtronic CoreValve Japan trial.
Osaka University Graduate School of Medicine cardiovascular surgery department professor Dr Yoshiki Sawa said: "We are excited to be able to offer this new option for our patients, as the CoreValve system has demonstrated exceptional clinical results in studies globally as well as in Japan."
According to the company, the CoreValve US trials demonstrated the safety and efficacy of the system with high rates of survival, while the Japanese trial also showed functional and anatomical effectiveness of CoreValve.
The CoreValve System received CE mark approval in 2007, and the FDA approval for patients at extreme risk in January 2014, while for high risk patients in June 2014.
Medtronic cardiac and vascular group heart valve therapies business general manager and vice-president Rhonda Robb said: "We look forward to working with Japan’s Ministry of Health, Labor and Welfare to gain reimbursement for CoreValve, and to initiating comprehensive training and education programs to support heart teams so that more patients may benefit from this break-through technology."
The company also markets recapturable CoreValve Evolut R transcatheter valve and CoreValve EnVeo R Delivery Catheter System in Europe and other countries that accept the CE mark.