Medtronic plc a global leader in healthcare technology, today announced four-year results from the Evolut Low Risk Trial. The Medtronic Evolut™ transcatheter aortic valve replacement (TAVR) system demonstrated exceptional outcomes and sustained valve performance, proven by significantly better hemodynamics than surgical aortic valve replacement (SAVR). Only Evolut TAVR has reported consistently lower and diverging rates of death or disabling stroke versus state-of-the-art surgery, at four years. The data were presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation and simultaneously published in the Journal of the American College of Cardiology.
Since the approval of TAVR in low-risk surgical patients, there is an ongoing need for evidence to better understand the intermediate and longer-term durability of TAVR devices of different designs.
"As we see patients in the Evolut Low Risk trial continue to show positive outcomes and sustained valve performance compared to surgery out to four years, this helps us establish intermediate-term evidence for Evolut TAVR and helps define what this might look like in the long term," said Dr. Michael Reardon, Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital and principal investigator of the trial. "These results are not only encouraging, but pivotal in shaping treatment decisions for low-risk patients with symptomatic severe aortic stenosis. We are seeing sustained, excellent valve performance in patients treated with Evolut TAVR, which ultimately translates into improved outcomes, including mortality and disabling stroke.1 This intermediate-term result underscores the belief that valve design matters, and previously published data points to superior outcomes* and better design in the Evolut TAVR platform."