W. L. Gore & Associates (Gore) announced today that the first patient has been enrolled in a US Food and Drug Administration (FDA) approved IDE study for the 45 mm* GORE TAG® Thoracic Endoprosthesis for treatment of aneurysms of the descending thoracic aorta. Grayson Wheatley, MD, Arizona Heart Institute, enrolled the first patient in the multi-center clinical study which will assess the safety and efficacy of the 45 mm GORE TAG Device for the primary treatment in patients with aortic inner diameters adjacent to the aneurysm ranging from 37 to 42 mm.
“We’re pleased to have initiated this study by enrolling the first patient,” said Dr. Wheatley. “The procedure went very smoothly, and the patient will likely be discharged from the hospital in 2-3 days. Without the availability of this 45 mm GORE TAG Device, the patient’s only alternative would have been open surgical repair which typically requires a hospital stay of 8-10 days.”
“This trial marks an important milestone at Gore as we continue our long history of leadership in providing medical device innovations that improve the treatment of patients affected with aortic aneurysms,” said John Sininger, for Gore. “We anticipate that the 45 mm GORE TAG Endoprosthesis could increase the potential treatment population of patients who may be available for endovascular repair by 10 to 15 percent.”
“We are very excited about the initiation of this clinical study of the 45 mm GORE TAG Thoracic Endoprosthesis as this new device enables us to expand the range of patients for which endovascular repair is an option. Patients treated by minimally invasive endovascular means typically suffer fewer early complications than those treated by the standard open surgical therapy,” commented Dr. Michel Makaroun, Chief, Division of Vascular Surgery, Professor of Surgery, University of Pittsburgh Medical Center, and National Principal Investigator for this study.
In March 2005, Gore received FDA approval to market the GORE TAG Thoracic Endoprosthesis in diameters ranging from 26-40 millimeters. As the first device of its kind approved in the US that provides a minimally invasive alternative to open surgery for treatment of aneurysms of the descending thoracic aorta, the GORE TAG Thoracic Endoprosthesis has had a profound impact on the lives of patients suffering from thoracic aortic aneurysms (TAA). Five year follow-up data indicates that subjects treated with the GORE TAG Endoprosthesis have improved aneurysm-related survival and a consistently lower incidence of major adverse events compared to subjects treated with open surgical repair.
Through 2006, approximately 16,000 GORE TAG Thoracic Endoprostheses have been implanted worldwide. The GORE TAG Device internally relines the thoracic aorta and isolates the diseased segment from blood circulation. The GORE TAG Endoprosthesis is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted by a catheter delivery technique through a small incision in the patient’s groin.
ABOUT W. L. GORE & ASSOCIATES, INC.
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 23 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery.
*Investigational Device. Limited by United States law to Investigational Use.
GORE and TAG® are trademarks of W. L. Gore & Associates.