Medtronic's CoreValve TAVR System Approved in Japan

March 30, 2015—Medtronic plc announced Japanese regulatory approval for the self-expanding transcatheter CoreValve system for patients with severe aortic stenosis unable to undergo surgery and for whom treatment with the CoreValve is determined to be the best option. Japanese regulatory authorities granted approval of the CoreValve system for transcatheter aortic valve replacement (TAVR) based on data from the CoreValve US Pivotal Trial of the device in extreme-risk and high-risk patients and the Medtronic CoreValve Japan trial.

In Medtronic’s press release, Yoshiki Sawa, MD, commented, “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 TAVR treatment decisions for patients who may benefit from a less-invasive valve replacement procedure with this proven, self-expandable valve.” Dr. Sawa is Professor in the Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine in Osaka, Japan.

Medtronic advised that data from the Extreme Risk study and High Risk studies in the CoreValve US Pivotal Trial demonstrated that the CoreValve system is safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported. The CoreValve system, with a supra-annular valve design, has achieved hemodynamic results after implantation similar to surgical valves.

The Medtronic CoreValve Japan trial confirmed the performance of CoreValve shown in the US Pivotal Trial. At 6 months, 91.7% of the transfemoral-access TAVR patients in the Japan trial met the primary endpoint of improvement of at least one New York Heart Association class and aortic valve area > 1.2 cm².  For all patients in the trial, freedom from all-cause mortality at 6 months was 90.8%. The trial also demonstrated the functional and anatomic effectiveness of the CoreValve device.

The company stated that the CoreValve self-expanding nitinol frame enables controlled delivery and accurate placement of the device. Valves are delivered via an 18-F TAVR delivery system that allows for the treatment of patients with difficult or small vasculature. The CoreValve system received European CE Mark approval in 2007. The device also received US Food and Drug Administration approval for extreme-risk patients in January 2014 and high-risk patients in June 2014.