FDA approves 45mm GORE TAG Thoracic Endoprosthesis device

W. L. Gore & Associates (Gore) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market a 45 mm diameter version of the GORE^® TAG^® Thoracic Endoprosthesis for 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 - 42 mm and is now available for commercial use in the U.S.

"The availability of the 45 mm GORE TAG Device will provide physicians treating thoracic aneurysms with more options," explained Dr. Michel Makaroun, Chief of the Division of Vascular Surgery and Professor of Surgery at the University of Pittsburgh Medical Center (UPMC). Dr. Makaroun acted as the National Principal Investigator for the 45 mm GORE TAG Device clinical study.

The 45 mm GORE TAG Device is available in 10, 15 and 20 cm lengths. In addition, all GORE TAG Devices, including the 45 mm device are delivered on a modified device delivery catheter that is designed for enhanced trackability and deliverability. The modified GORE TAG Device delivery catheter is a simple, single-step deployment system engineered to optimize placement and control. The novel 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. With more than 40,000 devices sold worldwide, the GORE TAG Device is the leading option for the less invasive treatment of TAA, an aneurysm of the descending thoracic aorta, the body's main circulatory vessel. TAA is a life-threatening condition generally believed to be significantly under-diagnosed, and patients with TAA are at risk of death due to internal bleeding resulting from a ruptured aorta.

"We are excited to expand the use of this proven device to a wider range of patients. The larger diameter GORE TAG Device provides physicians with a safe and effective way to treat TAA in patients with larger neck diameters," said David Abeyta, Aortic Business Unit Leader at Gore. "This is an endovascular option for treating TAA with proven results and benefits to the patient, and we look forward to continuing to provide innovative solutions for thoracic and other conditions moving forward."

The GORE TAG Device internally relines the thoracic aorta and isolates the diseased segment from blood circulation. The GORE TAG Device is comprised of an ePTFE 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.

The GORE TAG Device is also the only endovascular thoracic device with more than 10 years of worldwide commercial data. Five year follow-up data from the clinical study indicates that subjects treated with the GORE TAG Device have improved aneurysm-related survival and a consistently lower incidence of major adverse events compared to subjects treated with open surgical repair. Clinical studies are currently under way in the U.S. to evaluate the safety and efficacy of the next generation Conformable GORE TAG Device in three primary etiologies: aneurysms of the descending thoracic aorta (DTA), traumatic aortic transection of the DTA and acute complicated type B dissection.