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FDA OKs expanded use of endovascular graft to treat aortic tears
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The FDA has approved expanded use of the Gore TAG Thoracic Endoprosthesis endovascular graft to include treatment of life-threatening tears or ruptures of the aorta.
The device (W.L. Gore and Associates) is the first endovascular graft approved by the FDA to treat a variety of thoracic lesions, including aneurysms and thoracic aortic transections. The expanded approval provides surgeons with a minimally invasive and potentially less risky alternative to open chest surgery for the treatment of thoracic aortic transaction and other lesions.
The endovascular graft is compressed into a long, thin, tube-like delivery catheter. 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, according to information in a FDA press release.
The FDA first approved the Gore TAG Thoracic Endoprosthesis in 2005 to treat aortic aneurysms to reduce the risk for rupture. The expanded approval represents the latest design, which features materials that confirm to the bends and angles common in the area where thoracic aortic transections typically occur, according to the release.
FDA approval for expanded use was based on data from 51 patients implanted with the Gore TAG to treat thoracic aortic transaction 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 5 years.
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