W. L. Gore & Associates announced the first human implants of the next generation Conformable GORE TAG® Thoracic Endoprosthesis in the United States for the treatment of traumatic transection of the thoracic aorta. The first implants were performed by Dr. Joseph Van Camp at Hennepin County Medical Center in Minneapolis, Minnesota and Dr. Clifford Buckley assisted by Dr. Ruth Bush at Scott & White Hospital in Temple, Texas. Dr. Joseph Van Camp, thoracic surgeon at Hennepin County Medical Center said, "It is exciting to be part of the traumatic transection trial for the next generation Conformable GORE TAG Device and to investigate the potential expansion of TEVAR indications to include traumatic transections."
Gore received approval of an investigational device exception (IDE) from the US Food and Drug Administration (FDA) to investigate the use of the next generation Conformable GORE TAG Thoracic Endoprosthesis in traumatic aortic transection patients. Dr. Mark Farber from the University of North Carolina at Chapel Hill will serve as the national principle investigator (PI) for the Conformable GORE TAG Device Traumatic Aortic Transection Trial.
The next generation Conformable GORE TAG Device portfolio includes device diameters ranging from 21 – 45 mm as well as tapered devices, and the study will investigate the treatment of patients with aortic diameters of 16 – 42 mm. The smaller devices were designed to treat trauma patients who tend to be younger than patients with degenerative thoracic aortic disease.