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

SILVER SPRING, Md., Jan. 13, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection).

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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 Gore TAG endovascular 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.

"The FDA commends the manufacturer for recognizing the need to expand the indication of Gore TAG and for proactively working to obtain the safety and effectiveness data needed to support it," said Christy Foreman, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health.

"By obtaining FDA approval for this expanded use, physicians will now have access to risk and benefit information that can help them determine if the Gore TAG is appropriate for treating a patient with a thoracic aortic transection," said Foreman.

The aorta is the largest artery in the body, branching directly from the heart to supply blood to the rest of the body. 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 cath
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SOURCE U.S. Food and Drug Administration
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