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FDA Expands Use of Endovascular Graft to Treat Aortic Tears
Date:1/13/2012

eter. 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.

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.

FDA based its expanded approval on data from 51 patients implanted with the Gore TAG to treat thoracic aortic transection caused by trauma. Patients were monitored for 30 days with physician exams and follow-up X-ray and CT scans. All survived the implant procedure; four patients died from causes unrelated to the device or implant procedure. The company will continue to follow patients for five years.

W.L. Gore and Associates Inc. is based in Flagstaff, Ariz.

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FDA: Medical Devices

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Michelle Bolek, 301-796-2973, Michelle.Bolek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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