Interventional device developer Cook has received a Food and Drug Administration investigational device exemption (IDE) to begin a clinical investigation of its Zenith TX2 endovascular graft for thoracic aortic aneurysms (TAA).
The Bloomington, IN-based firm received conditional approval for a clinical trial involving 140 subjects at 20 U.S. institutions, and patient enrollment will begin soon. Zenith TX2 is already approved for commercial distribution in Australia and Asia.
By AuntMinnie.com staff writersDecember 11, 2003
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Cook gets OK to test new vascular stent, August 16, 2002
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