Gore has 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 Joseph Van Camp at Hennepin County Medical Center in Minneapolis, United States, and Clifford Buckley, assisted by Ruth Bush at Scott and White Hospital in Temple. Van Camp, thoracic surgeon, 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 exemption from the United States Food and Drug Administration to investigate the use of the next generation conformable Gore TAG thoracic endoprosthesis in traumatic aortic transection patients. Mark Farber from the University of North Carolina at Chapel Hill will serve as the national principal investigator 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 21–45mm as well as tapered devices, and the study will investigate the treatment of patients with aortic diameters of 16–42mm. The smaller devices were designed to treat trauma patients who tend to be younger than patients with degenerative thoracic aortic disease.
At LINC in Leipzig in January 2010, Peter Taylor, vascular surgeon, London, United Kingdom reported early experiences with the Gore TAG endoprosthesis. Good points, he noted, were that the device conforms to the arch unless it is very angulated, allowing arch aneurysms to be treated with a device which conforms to the inner curvature. The risk of device collapse is also reduced, and the absence of flares should reduce the problem of arch vessel emboli. Remaining problems he highlighted, however, are that dislocation of the nose cone exposes the leading edge of the device. Accurate positioning is also a problem, Taylor noted, and there may be problems with iliac rupture due to the size of the sheath and bringing a non-deployed device back into the sheath.
Traumatic thoracic aortic transection often results in death. Injury to the thoracic aorta from motor vehicle collisions account for up to 15% 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 Farber.
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.