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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.