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TAVR Registry Data Triggers Expansion Of FDA-Approved Indication

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.

FDA has agreed to expand the labeling for Edwards Lifesciences Corp.’s Sapien transcatheter aortic valve replacement, currently the only FDA-approved TAVR system, based largely on data from a post-market registry, the agency announced Sept. 23.

The new indication represents between 10 and 20 percent of TAVR patients, but the approval is even more significant due to the “message that FDA is sending in that they are looking at ways of post-market surveillance,” said Michael Mack, a cardiothoracic surgeon who chairs the steering committee of the

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