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FDA approves first endovascular grafts for aortic tears | Regulatory Roundup
The FDA granted W.L. Gore & Associates the first U.S. clearance for using an endovascular graft to treat tears or ruptures in the aortic wall.
Gore’s Conformable TAG thoracic endoprosthesis was approved as a treatment for a transection or tear in the aortic wall, an injury typically the result of a car accident, crushing of the chest or a fall from a high place, according to an FDA release.