Gore's next generation Conformable GORE TAG Thoracic Endoprosthesis enters clinical trial

W. L. Gore & Associates (Gore) 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.”

“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 (Gore TAG 08-02).

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.

Traumatic thoracic aortic transection often results in death. Injury to the thoracic aorta from motor vehicle collisions account for up to 15 percent of all deaths, and patients who survive usually have small tears or partial-thickness tears of the aortic wall with pseudoaneurysm formation. The proximal descending aorta is at greatest risk from the shearing forces of sudden deceleration. Therefore, the aorta is at greatest risk in frontal or side impacts, and falls from heights. Trauma patients with thoracic aortic transections often have multiple, complex injuries that increase the risk of standard surgical repair of the aorta. “We hope to gain insight and knowledge from this trial that will not only illustrate the GORE TAG Device’s capabilities, but will also help show that thoracic endografts can offer patients with traumatic aortic transection a less invasive alternative,” stated Dr. Farber, the national PI for the Gore TAG 08-02 Trial.

In addition to traumatic aortic transection, the next generation Conformable GORE TAG Device has been approved to investigate endovascular repair of other etiologies including thoracic aortic aneurysm and aortic dissection.

The commercially available GORE TAG Thoracic Endoprosthesis is a minimally invasive option for safely and effectively treating patients with descending thoracic aortic aneurysms. It is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. It received pre-market approval from the FDA in 2005.

“The clinical community has been looking for a minimally invasive treatment alternative to help treat traumatic aortic transection of the descending thoracic aorta,” said David Abeyta, Aortic Business Unit Leader at Gore. “This clinical trial highlights Gore’s legacy in aortic clinical research and our ongoing commitment to bring to market innovative technology that will allow the medical community to more effectively treat patients.”

Investigational Device – Limited by United States Law to Investigational Use.

http://www.goremedical.com/

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