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

JAMA Cardiol. 2020 Jan 1;5(1):5-6. doi: 10.1001/jamacardio.2019.4383.

Authors

Changfu Wu¹, Bernard Vasseur¹, William Maisel²

Affiliations

¹ Division 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.
² Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.

PMID: 31721988
DOI: 10.1001/jamacardio.2019.4383

No abstract available

MeSH terms

Age Factors
Aortic Valve / pathology*
Aortic Valve / surgery
Aortic Valve Stenosis / surgery*
Calcinosis / surgery*
Decision Making, Shared
Device Approval*
Heart Valve Prosthesis Implantation
Heart Valve Prosthesis*
Humans
Patient Selection
Product Labeling
Prosthesis Failure
Risk
Severity of Illness Index
Transcatheter Aortic Valve Replacement / methods*
United States
United States Food and Drug Administration

Supplementary concepts

Aortic Valve, Calcification of