FDA approves the CoreValve Evolut PRO TAVR valve for high or extreme risk patients
The FDA approved the CoreValve Evolut PRO valve for transcatheter aortic valve replacement (TAVR) in patients with severe, symptomatic aortic stenosis who are at high or extreme risk for open heart surgery.
Medtronic announced the approval on March 22.
The self-expanding, repositionable Evolut PRO is Medtronic's next generation TAVR valve. The FDA previously approved Medtronic’s original CoreValve and Evolut R valves.
The Evolut PRO is built on the Evolut R’s platform and includes a self-expanding nitinol frame with its supra-annular valve position, according to Medtronic. The Evolut PRO is indicated for vessels down to 5.5 mm and is available in 23 mm, 26 mm and 29 mm sizes in the U.S. The valve is not approved outside the U.S.
The approval of the Evolut PRO came a few days after Medtronic presented data at the American College of Cardiology (ACC) scientific session from a study of 60 patients who were implanted with the valve.
At 30 days, 1.7 percent of patients had died and 1.7 percent of patients had disabling strong. In addition, 72.4 percent of patients had none or trace paravalvular leaks (PVL) and the remaining 27.6 percent had mild PVL. There were no incidents of moderate or severe PVL at 30 days.
Further, Medtronic said the valve had strong hemodynamic performance and had a new permanent pacemaker rate of 10 percent.
“The 30-day clinical outcomes presented at ACC demonstrate the Evolut PRO valve to be an outstanding treatment option for patients with severe aortic stenosis who are at a high or extreme risk for surgery,” John Forrest, MD, an assistant professor of medicine at Yale University School of Medicine who presented the 30-day data, said in a news release.
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.