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TAVR Registry Data Triggers Expansion Of FDA-Approved Indication

This article was originally published in The Gray Sheet

Executive Summary

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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