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Zenith TX2 graft

This article was originally published in The Gray Sheet

Executive Summary

Cook projects first quarter 2008 U.S. launch of its Zenith TX2 thoracic aortic aneurysm endovascular graft following submission to FDA of the final PMA module, announced Aug. 7. The PMA includes data from the 230-patient STARZ-TX2 trial, which was presented at the Society for Vascular Surgery conference in Baltimore June 9. Zenith's TX2 is already available in Europe, Australia and New Zealand. Gore's TAG TAA device was approved in 2005, and Medtronic is seeking approval for its Talent TAA graft (1"The Gray Sheet" Jan. 1, 2006, In Brief)...

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Cook’s Zenith TX2 graft approval

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)

Medtronic’s Valiant thoracic aneurysm stent graft

Firm begins two clinical trials of its Valiant second-generation thoracic aortic aneurysm stent graft. Announced Dec. 15, the 125-patient Valor II U.S. trial will evaluate Valiant to treat descending thoracic aortic aneurysms. The firm also has initiated a 100-patient Virtue registry study in Europe to collect extra data on treatment of descending thoracic aortic dissections. Medtronic plans a U.S. marketing submission in two years. CE marked in 2005, Valiant is the leading thoracic aortic aneurysm endograft outside the United States, the firm says. Medtronic also offers its Talent thoracic stent graft outside the United States and hopes to gain FDA approval soon. Competitors include Cook (Zenith TX2) and Gore (TAG); the latter device is approved by FDA (1"The Gray Sheet" Aug. 7, 2006, In Brief)...

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