Office of Cardiovascular Devices - Meadowbrook Care Center

FDA Expands TAVR Indication to Low-Risk Patients

By Meadowbrook Staff | August 21, 2019 |

Hot off the Press…The U.S. Food and Drug Administration (FDA) approves an expanded indication for several transcatheter heart valves (Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO) to include patients with severe aortic valve stenosis at low surgical risk. According to the FDA, the incidence of aortic valve stenosis increases with age.…