Cook’s Zenith TX2 graft approval
This article was originally published in The Gray Sheet
Executive Summary
Cook gains PMA approval for its Zenith TX2 thoracic aortic aneurysm endovascular graft. The device is indicated for patients with "aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair," according to Cook. The company completed its modular PMA submission last August and announced approval May 23. Gore's TAG TAA device was approved in 2005; and Medtronic is seeking approval for its Talent TAA graft (1"The Gray Sheet" Aug. 13, 2007, In Brief)