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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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J Am Coll Cardiol 2013 Sep 10;62(11):1026-34

The STS-ACC Transcatheter Valve Therapy National Registry: A New Partnership and Infrastructure for the Introduction and Surveillance of Medical Devices and Therapies.

Carroll JD, Edwards FH, Marinac-Dabic D, Brindis RG, Grover FL, Peterson ED, Tuzcu EM, Shahian DM, Rumsfeld JS, Shewan CM, Hewitt K, Holmes DR Jr, Mack MJ


The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) transcatheter valve therapy (TVT) registry is a novel, national registry for all new TVT devices created through a partnership of the STS and the ACC in close collaboration with the Food and Drug Administration, the Center for Medicare and Medicaid Services, and the Duke Clinical Research Institute. The registry will serve as an objective, comprehensive, and scientifically based resource to improve the quality of patient care, to monitor the safety and effectiveness of TVT devices, to serve as an analytic resource for TVT research, and to enhance communication among key stakeholders.

Category: Journal Article
PubMed ID: #23644082 DOI: 10.1016/j.jacc.2013.03.060
Includes FDA Authors from Scientific Area(s): Medical Devices
Entry Created: 2013-10-07