Medtronic Announces Japanese Regulatory Approval of CoreValve® System

Medtronic plc (NYSE: MDT) today announced Japanese regulatory approval for the self-expanding transcatheter CoreValve® System for patients with severe aortic stenosis (AS) 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 implantation (TAVI) based on robust data from the CoreValve U.S. Pivotal Trials and the Medtronic CoreValve Japan Trial, which is the first study to evaluate a self-expandable transcatheter valve in the Japanese patient population.
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news