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- Title
The International Registry Infrastructure for Cardiovascular Device Evaluation and Surveillance.
- Authors
Sedrakyan, Art; Marinac-Dabic, Danica; Holmes Jr., David R.
- Abstract
The authors discuss the aspects of potential for development of national and international registries surveillance infrastructure for cardiovascular devices by the U.S. Food and Drug Administration (FDA) Medical Device Epidemiology Network (MDEpiNet). They also reflect on the aspects of the development of infrastructure as an initial project with the focus on transcatheter aortic valve replacement (TAVR).
- Subjects
CARDIOVASCULAR diseases; MEDICAL equipment; MEDICAL supplies; UNITED States. Food &; Drug Administration; AORTIC valve transplantation
- Publication
JAMA: Journal of the American Medical Association, 2013, Vol 310, Issue 3, p257
- ISSN
0098-7484
- Publication type
Opinion
- DOI
10.1001/jama.2013.7133