Medtronic Gains CE Mark Approval for 31-mm CoreValve System

August 18, 2011—Medtronic, Inc. (Minneapolis, MN) announced it has received CE Mark approval for its 31-mm CoreValve transcatheter aortic valve system for the treatment of patients with larger valve openings (up to 29 mm). It can be compressed to be deployed through the same 18-F delivery system used for the smaller-sized CoreValve devices. The company's CoreValve portfolio includes 26-, 29-, and 31-mm valves; all are based on the self-expanding platform that received CE Mark approval in 2007. The CoreValve system is designed for treatment of patients with symptomatic, severe aortic stenosis who are at high risk or ineligible for open heart surgery. The CoreValve system is currently limited to investigational use in the United States, the company advised.

“The 31-mm CoreValve size allows us to provide a lifesaving treatment option for more patients with severe aortic stenosis,” commented Prof. Ulrich Schäfer, MD. “We have seen positive clinical outcomes with the CoreValve system and are pleased to offer it to individuals who, until now, have been denied transcatheter aortic valve implantation due to their larger native valve size.”