FDA Approves Conformable Gore TAG Thoracic Endoprosthesis

November 16, 2011—Gore & Associates (Flagstaff, AZ) announced that it has received approval from the US Food and Drug Administration to market the Conformable Gore TAG thoracic endoprosthesis as a minimally invasive treatment of thoracic aortic aneurysms. The company made the announcement at the annual VEITHsymposium in New York City.

According to the company, the device is an expanded polytetrafluoroethylene thoracic endoprosthesis designed for endovascular repair of the descending thoracic aorta. Gore stated that the device offers conformability and ease of use, while accommodating tapered anatomy and resisting compression. The broad oversizing window for the device ranges from 6% to 33%, allowing interventionists to choose the appropriate oversizing for the patient anatomy. The device is available in diameters of 21 to 45 mm, allowing for the treatment of patients with aortic diameters of 16 to 42 mm. Tapered device configurations are also available, the company advised. 


William Jordan, MD, served as national Principal Investigator for the Gore TAG 08-03 clinical trial that evaluated the Conformable Gore TAG device in the thoracic aortic aneurysm.

Dr. Jordan commented, “This new device represents a substantial product improvement brought to us by a company that was already leading the market in aneurysm devices. Gore evaluated the real-world results of the first-generation endograft and engineered improvements so that the device can be used across a wider range of aortic diameters with stronger radial force to resist compression. These modifications are intended to improve the lives of our patients and provide better outcomes for challenging clinical problems.”