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November 13, 2019

The March of Transcatheter Aortic Valve Replacement Therapy—US Food and Drug Administration Perspectives on Device Approval for Patients at Low Surgical Risk

Author Affiliations
  • 1Division of Circulatory Support, Structural and Vascular Devices, Office of Cardiovascular Devices, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
  • 2Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
JAMA Cardiol. Published online November 13, 2019. doi:https://doi.org/10.1001/jamacardio.2019.4383

On August 16, 2019, the US Food and Drug Administration (FDA) became the first regulatory body worldwide to expand the indications for use of transcatheter aortic valve replacement (TAVR) devices to patients with severe aortic stenosis who are at low risk for surgical aortic valve replacement (SAVR). The primary data to support this new approval for the SAPIEN 3 and SAPIEN 3 Ultra (Edwards Lifesciences LLC) and the CoreValve Evolut R and CoreValve Evolut PRO (Medtronic CoreValve LLC) TAVR devices came from 2 randomized clinical trials (namely, the PARTNER 3 Trial—the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis trial [NCT02675114] and the Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial; NCT02701283]).1,2 This first-in-the-world approval for patients at low surgical risk stands in stark contrast to the FDA’s 2011 approval of the first-generation SAPIEN device (Edwards Lifesciences LLC; for patients deemed inoperable for SAVR), in which the United States was the 42nd country in the world to approve a TAVR device.

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