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.
An aortic tear causes internal bleeding and is frequently fatal. The only other approved treatment option prior to Gore’s win was open surgical repair, according to agency.
The latest approval was made on the basis of data from 51 patients implanted with the Gore device to treat aortic tears caused by trauma.
All patients survived the implant procedure, and 4 died from causes unrelated to the device or implant procedure within the 30-day monitoring period. Gore plans to continue following the patients for 5 years, according to the release.
An endovascular graft is a fabric tube supported with a metal mesh frame, compressed into a catheter for delivery to the injury site.
Gore calls its device the only FDA cleared endoprosthesis specifically designed for young trauma patients. It is inserted via catheter through a small incision in the groin and threaded up the leg artery and into the chest, according to a press release.
The Conformable device first won FDA clearance in 2005 to treat aortic aneurysms to reduce the risk of rupture. The expanded approval applies to the latest device design, which features more flexible materials to conform to the curved areas where aortic tears commonly occur, according to the FDA release.
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