Panel Critiques TAG Graft Study Size, But Deems Approval “Common Sense”
This article was originally published in The Gray Sheet
Executive Summary
The appeal of WL Gore's TAG thoractic endograft as a less-invasive alternative to open-heart surgery swayed FDA panelists to recommend device approval Jan. 13
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TAG Thoracic Endograft Approval Makes Gore First To Market In U.S.
Gore is negotiating with FDA the number of participants required for a post-approval study of TAG endoprosthesis to treat thoracic aortic aneurysms
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