FDA paves way for international cardiovascular registry

The FDA will hold a public meeting to discuss developing an international consortium of cardiovascular registries. The initial thrust of the effort will be on transcatheter cardiac valve registries, with a later expansion to include additional cardiovascular devices.

The consortium will be designed to harness resources from registries, which individually often are limited in scope and size. “Developing a comprehensive understanding of the performance of these devices requires not only an in-depth analysis across data sources to link device use to clinical outcomes, but also to incorporate data from international experience with these devices and procedures,” according to the FDA.

The FDA will oversee the meeting with the goal of including broad-based analysis and surveillance of medical devices and related clinical outcomes. The agency said it modeled its approach from the International Consortium of Orthopedic Registries (ICOR). After the meeting, participants and stakeholders are expected to develop a plan to develop an international consortium of cardiovascular registries, identify key issues and suggest a roadmap for full implementation.

The meeting will address postmarket surveillance; goals; lessons learned from ICOR; a pilot phase focused on transcatheter valve registries; analysis of outcomes reported through registries; and a discussion of capabilities, challenges and limitations of existing transcatheter valve registries.

The FDA will accept electronic or written comments through May 22. To learn more, or to register for the meeting, go here.