Michael D. Dake
Publication Details
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Endovascular repair of the thoracic aorta in the post-FDA approval era.
J Thorac Cardiovasc Surg. 2009; (1): 117-23
Endovascular repair of thoracic aortic disease is rapidly progressing as an alternative to open surgical therapy. In March of 2005, the Gore TAG thoracic endoprosthesis (W. L. Gore & Associates, Inc, Flagstaff, Ariz) received Food and Drug Administration (FDA) approval for the treatment of descending thoracic aortic aneurysms. Subsequently, off-label use of the technology expanded to include additional thoracic aortic diseases. The purpose of this study was to examine whether the outcomes with this device changed after the inclusion and exclusion criteria of FDA-controlled trials no longer governed patient selection.
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