The FDA expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates to include treatment of thoracic aortic transection.
The Gore TAG Thoracic Endoprosthesis is the first FDA-approved endovascular graft to treat a variety of thoracic lesions, including "dangerously large" aneurysms as well as thoracic aortic transections, according to the agency. The FDA added that expanded approval of the Gore TAG endovascular graft provides surgeons with a minimally invasive and potentially less risky alternative to open chest surgery for the treatment of thoracic aortic transection and other lesions.
“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 Christy L. Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.
The FDA first approved the Gore TAG in 2005 to treat aortic aneurysms to reduce the risk of rupture. The expanded approval represents the latest design, which features materials that conform to the bends and angles common in the area where thoracic aortic transections typically occur.
The FDA said it based the expanded approval on data from 51 patients implanted with the Gore TAG to treat thoracic aortic transection 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 Flagstaff, Ariz.-based company will continue to follow patients for five years.