Medtronic (NYSE:MDT) said today that the FDA granted pre-market approval for its CoreValve Evolut R replacement heart valve, less than a week after approving the competing Sapien 3 valve made by Edwards Lifesciences (NYSE:EW).
The devices are 3rd-generation transcatheter aortic valve implants designed to treat leaky heart valves. Both the CoreValve Evolut R and the Sapien 3 are designed to reduce the paravalvular leakage that plagued earlier iterations.
“The FDA approval of Evolut R marks a significant milestone for Medtronic and TAVI, and ushers in a new era in transcatheter aortic valves with advanced, recapturable capabilities,” vice president Rhonda Robb said in prepared remarks. “This approval is an outcome of our commitment to building a market-leading innovation pipeline in the transcatheter space, and we look forward to supporting heart teams as they look to next-generation technologies that optimize valve performance for a broad range of patients.”
“In a short time, the TAVI procedure has become an established treatment option for high-risk patients with severe aortic stenosis who are unable undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes,” added Dr. Mathew Williams of New York’s NYU Langone Medical Center. “Clinical data have shown the best patient outcomes are achieved when the valve is properly positioned. The advancement of recapturability with Evolut R gives physicians more confidence during the procedure and provides advantages that are non-existent in other TAVR systems.”
Williams is co-principal investigator of Medtronic’s U.S. clinical study of the CoreValve Evolut R, which won CE Mark approval in the European Union in September 2014.