Medtronic’s Valiant thoracic aneurysm stent graft
This article was originally published in The Gray Sheet
Executive Summary
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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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)...
Cook TAA graft trial
Firm completes enrollment for its STARZ-TX2 clinical trial comparing the Zenith TX2 endovascular graft to open surgery in the treatment of thoracic aortic aneurysms. The 200-patient trial, conducted at 39 sites, will evaluate patient survival and rupture rates over 12 months. WL Gore (Gore TAG) was first-to-market in the TAA endograft space in March 2005, with Medtronic (Talent) aiming to be next (1"The Gray Sheet" March 28, 2005, p. 13). Medtronic completed enrollment of its VALOR pivotal trial for Talent in June 2005...
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