Good news for W. L. Gore & Associates: The FDA has signed off on an expanded use for the privately held company's TAG thoracic endoprosthesis (pictured) for use in repairing aortic tears, the company announced last week. It is the first endoprosthesis designed to treat the anatomy of young trauma patients.
The indication expansion could prove a major win for the company, which is known for its Gore-Tex fabrics. The endoprosthesis will help those patients who injure their aorta in a car accident or fall, Mark Farber, the national principal investigator for the trial used to help expand the indication, told FierceMedicalDevices. The device, a metal and fabric combination, is delivered by a catheter and inserted into the femoral artery through a small incision in the groin and guided up to the injury location. It helps stops blood flow and helps allow the artery to heal. And, unlike open surgery, the procedure is quick, taking roughly 30 to 45 minutes, Farber added.
The device also helps improve surgical outcomes as the patient experiences less potential for blood loss and paraplegia after the procedure versus traditional surgery, Farber told FMD.
The FDA first approved the Gore TAG in 2005 to treat aortic aneurysms to reduce the risk of rupture. The agency based its decision on data from 51 patients who were implanted with the Gore TAG. All survived the implant procedure with four dying from causes unrelated to the device or implant procedure. The company will continue to follow patients for 5 years.
The company is not stopping with this latest indication, however. It also has an ongoing U.S. trial investigating the device for acute dissection.
- read Gore's release
- check out the FDA's release