TAG Thoracic Endograft Approval Makes Gore First To Market In U.S.
This article was originally published in The Gray Sheet
Executive Summary
Gore is negotiating with FDA the number of participants required for a post-approval study of TAG endoprosthesis to treat thoracic aortic aneurysms
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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...
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...