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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-13
March 23, 2005

Media Inquiries: Julie Zawisza, 301-827-6242
Consumer Inquiries: 301-443-7490


 

FDA Approves First-of-Kind Device to Treat Descending Thoracic Aneurysms

The Food and Drug Administration (FDA) today approved a new device that is intended to prevent ruptures of descending thoracic aneurysms by making a new path for blood flow. The GORE TAG Endoprosthesis System is the first endovascular grafting system approved to treat aneurysms of the thoracic aorta, the main artery that carries blood in the body.

A thoracic aortic aneurysm is a diseased, weakened, and bulging section of the aorta in the chest. This condition, if not treated, could result in a rupture (bursting) of the aorta, leading to life-threatening internal bleeding. The aneurysm may be caused by vascular disease, injury, or an inherited (genetic) defect of the tissue.

The GORE TAG Endoprosthesis System consists of an endovascular graft made of ePTFE (expanded polytetrafluoroethylene) and a metallic support structure, and 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, thus strengthening the vessel and relieving pressure that could cause a rupture. The procedure, while less-invasive, than conventional surgery, does require regular follow-up medical visits and tests to monitor the success of the treatment over time.

Typically, descending thoracic aneurysms are managed either medically with blood pressure-lowering drugs to reduce risk of rupture, or by surgical repair. Large aneurysms are at significant risk of rupture, which often is fatal. Conventional surgical repair requires a major chest operation in which the aneurysm is replaced by a graft. Such surgery is associated with prolonged hospitalization, post-operative monitoring in an intensive care unit, and a recuperation period of three to six months.

FDA approved the Endoprosthesis System based on review of two clinical studies of the System's safety and effectiveness. These studies involved approximately 200 people. Study results showed that aneurysm-related deaths were lower in patients who had received the endoprosthesis than in the surgical control group.

FDA is requiring that Gore conduct post-approval 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.

The GORE TAG Endoprosthesis System is manufactured by W.L. Gore and Associates, Inc. of Flagstaff, Arizona.

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