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FDA Expands Indication for Several Transcatheter Heart Valves to Patients at Low Risk

Friday, August 16, 2019

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Source Name: US Food and Drug Administration



The FDA-approved use of TAVR has now expanded to low-risk patients with severe aortic stenosis.  This includes both Edwards Lifesciences' Sapien 3 and Sapien 3 Ultra as well as Medtronic's  Evolut R and Evolut PRO.   

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