The international registry infrastructure for cardiovascular device evaluation and surveillance

Journal JAMA
Authors Sedrakyan, Art; Marinac-Dabic, Danica; Holmes, David
Year Published 2013
Link to publication

Since the creation of the US Food and Drug Administration (FDA) Medical Device Epidemiology Network (MDEpiNet), there has been an increasing FDA commitment to support the development of a global medical device research and surveillance infrastructure. The FDA’s new postmarket surveillance plan strengthens this commitment and highlights the importance of national and international registries, and multi-stakeholder involvement for ensuring this commitment is fulfilled.This Viewpoint summarizes the potential for development of an International Consortium of Cardiovascular Registries, modeled on a consortium established for orthopedic devices, as an initial project in the realm of cardiovascular devices with the focus on transcatheter aortic valve replacement (TAVR).