Endovascular Graft Approved for Tears of Aorta
The body's largest artery
MONDAY, Jan. 16 (HealthDay News) -- The U.S. Food and Drug Administration has expanded approval of an endovascular graft to include ruptures of the aorta, the body's largest artery.
The Gore Tag Thoracic Endoprosthesis was first sanctioned in 2005 to treat aortic bulges called aneurysms, the agency said in a news release. Use of the graft to treat aortic tears will spare patients more invasive open chest surgery.
The graft, produced by Flagstaff, Arizona-based W.L. Gore and Associates, contains a metal mesh frame surrounded by a fabric tube. Implantation is done via a catheter inserted into a leg artery.
Approval for the new use was granted based on clinical studies involving 51 people with aortic tears. Gore will follow patients implanted with the device for five years, the FDA said.
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