The Food and Drug Administration (FDA) today expanded the approved usage of the Gore® TAG® Thoracic Endoprosthesis for an endovascular graft to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). The Gore TAG Thoracic Endoprosthesis is the first endovascular graft approved by the FDA to treat a variety of thoracic lesions, including dangerously large bulges in the aorta (aneurysms) as well as thoracic aortic transections. The expanded approval of the graft provides surgeons with a minimally invasive and potentially less risky alterative to open chest surgery for the treatment of thoracic aortic transection and other lesions. A thoracic aortic transection, most often caused by a traumatic injury to the chest as a result of a motor vehicle accident, crushing of the chest, or a fall from a high height, results in profuse bleeding and is frequently fatal. An endovascular graft is a fabric tube supported with a metal mesh frame. The endovascular graft is compressed into a long, thin, tube-like delivery catheter. The catheter is inserted into an artery in the leg and directed through the arteries to the site of the rupture or tear, where the endovascular graft is released. Once released, the endovascular graft expands against the wall of the aorta to redirect blood flow away from the tear or rupture. The FDA first approved the Gore TAG in 2005 to treat aortic aneurysms to reduce the risk of rupture. The expanded approval represents the latest design, which features materials that conform to the bends and angles common in the area where thoracic aortic transections typically occur. The FDA based its expanded approval on data from 51 patients implanted with the Gore TAG to treat thoracic aortic transection caused by trauma. The patients were monitored for 30 days with physician examinations and follow-up x-ray and computed tomography (CT) scans. All survived the implant procedure; 4 patients died from causes unrelated to the device or implant procedure. The company will continue to follow the patients for 5 years.
-
Food and Drug Administration (FDA). News & Events. FDA News Release. FDA expands use of endovascular graft to treat aortic tears. January 13, 2012. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm287698.htm. Accessed January 17, 2012.