FDA's new global cardiovascular registry to start with transcatheter heart valves

April 3, 2013 by Arezu Sarvestani

The FDA announces a public meeting to discuss international cooperation in monitoring and assessing cardiovascular medical devices, with an initial pilot phase to focus on transcatheter heart valves.

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The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.

The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."

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"Observational studies and registries have become increasingly important data sources for assessing the performance of cardiovascular therapeutic medical devices in the real-world setting," according to an FDA notice in the Federal Register. "However, these registries are often limited in scope and size to a specific country, region, or health care provider system."

The agency hopes to remedy some of the limitations of existing registries by combining efforts and sharing data. The new consortium would serve to consolidate observations from various data sources to enable broad analysis and surveillance of the medical technologies and their clinical outcomes.

The FDA hopes to glean lessons from the success of the International Consortium of Orthopedic Registries, which has a globally coordinated analysis team and a framework for which the cardiovascular consortium to build on.