June 8, 2010 – A 45 mm diameter stent graft to treat thoracic aortic aneurysms (TAA) has been cleared by the U.S. Food and Drug Administration (FDA). W. L. Gore & Associates said its new, larger version of the Gore Tag Thoracic Endoprosthesis is for the treatment of aneurysms of the descending thoracic aorta.
The larger diameter device allows treatment of TAAs with proximal and distal neck diameters ranging from 37 to 42 mm.
“The availability of the 45 mm Gore Tag Device will provide physicians treating thoracic aneurysms with more options,” explained Michel Makaroun, M.D., chief of the division of vascular surgery and professor of surgery at the University of Pittsburgh Medical Center (UPMC). Makaroun acted as the national principal investigator for the device clinical study.
The Gore Tag is available in 10, 15 and 20 cm lengths. In addition, the devices are delivered on a modified device delivery catheter that is designed for enhanced trackability and deliverability. The modified device delivery catheter uses simple, single-step deployment. The sheathless delivery catheter provides flexibility for navigating tortuous anatomy and low deployment forces.
The Gore Tag device was first approved by the FDA in March 2005. It internally relines the thoracic aorta and isolates the diseased segment from blood circulation. The device is comprised of an ePTFE (Gore-Tex) graft with a self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted via a catheter delivery technique through a small incision in the patient’s groin.
For more information: www.goremedical.com