Ireland-based medical technology firm Medtronic has received approval from the Japanese regulatory authority for its self-expanding transcatheter CoreValve system to treat patients with severe aortic stenosis (AS) who are unable to undergo surgery.
Approval for the CoreValve system for transcatheter aortic valve implantation (TAVI) was based on data from the CoreValve US Pivotal Trial and the Medtronic CoreValve Japan Trial.
The CoreValve Japan Trial is the first study to evaluate a self-expandable transcatheter valve in the Japanese patient population.
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.
"Physicians in Japan should have confidence in making TAVI treatment decisions for patients who may benefit from a less invasive valve replacement procedure with this proven self-expandable valve."
Data from the CoreValve US trial showed 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 company said the CoreValve System, with a supra-annular valve design, also achieved haemodynamics or blood flow, post-implant with results similar to the gold standard surgical valves.
The CoreValve self-expanding nitinol frame allows physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.
Medtronic Heart Valve Therapies business vice-president Rhonda Robb said: "The feedback from heart teams around the world using CoreValve has been overwhelmingly positive and we are confident that Japanese physicians will embrace the therapy.
"We look forward to working with Japan’s Ministry of Health, Labour 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 CoreValve System secured CE Mark in 2007 and the FDA approved the system for patients at extreme risk in January 2014 and for high-risk patients in June 2014.