Built upon the proven Evolut platform, the Evolut PRO+ system offers the lowest delivery profile for 23-29 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealing with an external tissue wrap. Medtronic also announced plans to begin a feasibility study of the Evolut™ TAVR platform to evaluate the self-expanding, supra-annular valve in patients with symptomatic moderate and asymptomatic severe aortic stenosis, new patient populations outside of current guidelines and indications for aortic valve replacement. For many of these and other TAVR patients, valve design matters,” said Howard C. Herrmann, M.D., the John Winthrop Bryfogle Professor of Cardiovascular Diseases and director of interventional cardiology in the Perelman School of Medicine at the University of Pennsylvania, and principal investigator and chair of the Steering Committee of the SMART Trial. The Evolut TAVR platform – including the Evolut™ R, Evolut™ PRO and Evolut™ PRO+ TAVR Systems – is indicated for symptomatic severe AS patients across all risk categories (extreme, high, intermediate and low) in the U.S. Medtronic has now added to the evidence by releasing results from a clinical trial of its Evolut TAVR devices in bicuspid patients. Medtronic estimates the market for bicuspid and tricuspid aortic stenosis patients combined, who are at low risk for surgery, at 320,000 individuals in the U.S., Western Europe and Japan, a company spokesperson told MedTech Dive in an email. “Moderate aortic stenosis, if left untreated, can be just as deadly for patients as the more severe forms of the disease,” said Jeffrey Popma, M.D., chief medical officer and vice president, medical affairs for the Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic. Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients. The CE mark for Evolut includes new labeling that permits treatment of patients with bicuspid aortic valves for patients at extreme, high and intermediate risk of surgical mortality. The congenital heart defect occurs in 1% to 2% of people, yet bicuspid aortic valve stenosis represents almost 40% of the intermediate- and high-risk symptomatic aortic stenosis patient population, according to Medtronic data. FDA authorization in the low-risk group followed the release of results from two key studies at the American College of Cardiology's annual meeting in March 2019. About Medtronic DOWNLOAD BROCHURE Sep 22 – Nov 19, 2020, •

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