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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.