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)...