FDA Approves GORE TAG to Treat Descending Thoracic Aneurysms

The FDA has approved the GORE TAG Endoprosthesis System, an endovascular grafting system that is intended to prevent ruptures of descending thoracic aneurysms by making a new path for blood flow.

The GORE TAG Endoprosthesis System, manufactured by Flagstaff, Ariz.-based W.L. Gore, consists of an endovascular graft made of expanded polytetrafluoroethylene and a metallic support structure, along with a delivery system used to implant the graft. The endovascular graft is delivered by a catheter inserted into the femoral artery in the groin. The graft re-lines the inside of the weakened aortic wall, strengthening the vessel and relieving pressure that could cause a rupture.

The FDA approved the Endoprosthesis System based on review of two clinical studies of the system's safety and effectiveness. The agency is requiring that Gore conduct postapproval studies to assure that when the endovascular grafting system is used in the large general population, its safety and effectiveness will be comparable to the clinical trials, and to evaluate the long-term clinical performance of the device.