TAVR Registry Data Triggers Expansion Of FDA-Approved Indication
This article was originally published in The Gray Sheet
FDA has changed the indication for transcatheter aortic valves to include any access approach for inoperable patients. The new indication, based largely on registry data, is significant due to the “message that FDA is sending in that they are looking at ways of post-market surveillance,” said surgeon Michael Mack.
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The trade group released revised data registry principles aimed at ensuring adequate data governance and containing “threshold questions” one should consider before implementing a registry as opposed to another form of information gathering.
The first report from the U.S. TVT Registry of transcatheter aortic valve replacement shows procedural and in-hospital outcomes comparable to those seen in randomized trials and international registries.
The agency held a stakeholder meeting to discuss the creation of an international consortium of transcatheter valve registries to serve as the model for future cardiovascular device registry collaborations.