Medtronic announced on August 1 that its CoreValve Evolut R system had received a CE mark in Europe to treat patients with aortic stenosis who are at intermediate risk for open heart surgery.
The Evolut R is the first transcatheter aortic valve replacement (TAVR) device to receive a CE mark for intermediate-risk patients, according to the company.
The FDA approved the Evolut R in June 2015 to treat high- or extreme-risk patients with severe aortic stenosis.
The device is not FDA-approved for intermediate- or low-risk patients. However, Medtronic is looking to expand the approval and enrolled the first patient in March in a trial examining the Evolut R in low-risk patients.
The CE mark was based on results of a subset analysis from the CoreValve U.S. high-risk pivotal trial and the NOTION (Nordic Aortic Valve Intervention) trial.