FDA expands approval for Medtronic’s CoreValve Evolut R system in larger size
The FDA approved Medtronic’s CoreValve Evolut R system in a new 34 mm size valve for patients undergoing transcatheter aortic valve replacement (TAVR).
The valve is indicated for patients with severe aortic stenosis who are at high or extreme risk for surgery and have an annulus size from 26 mm to 30 mm, according to the company. Medtronic said in a news release that some of these patients could not undergo TAVR until this approval.
The FDA originally approved the Evolut R system in June 2015 in 23 mm, 26 mm and 29 mm sizes.
“We’re pleased to have more options to offer patients suffering from severe aortic stenosis who are at high risk or unable to have open-heart surgery,” Mathew Williams, MD, co-primary investigator for the Evolut 34mm clinical study, said in a news release. “This new, larger valve offers patients with larger anatomical structures access to TAVR. For physicians, the recapturable and repositionable Evolut R can lead to increased accuracy in placement and control during the procedure.”
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.