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Medtronic announces FDA approval and U.S. launch of next-gen Evolut PRO+ TAVR system for symptomatic severe aortic stenosis

Press releases may be edited for formatting or style | September 23, 2019 Operating Room

Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body and, therefore, impacting an individual’s daily activities. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.

“We anticipate the Evolut PRO+ TAVR System will help heart teams fine-tune their TAVR procedures, further building on the consistent and reliable outcomes that they have come to expect from the Evolut TAVR platform – including positive hemodynamic outcomes in part, due to its supra-annular valve design – which we continue to see with the Evolut platform across large-scale, randomized clinical trials,” said Pieter Kappetein, M.D., Ph.D., vice president and chief medical officer for the Structural Heart and Cardiac Surgery businesses, which are part of the Cardiac and Vascular Group at Medtronic. “In addition to a decrease in profile for the core sizes to help minimize burden on the vessels during the procedure, the Evolut PRO+ TAVR System gives heart teams a familiar technology that’s been fine-tuned to help drive excellent patient outcomes.”

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The Evolut TAVR platform, including the Evolut™ R, Evolut™ PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.


About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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