Conformable Gore TAG Device Used in IDE Trial

October 20, 2009—W. L. Gore & Associates (Flagstaff, AZ) announced the first human implants of the next-generation Conformable Gore TAG thoracic endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The company received approval of an investigational device exemption from the US Food and Drug Administration (FDA) to investigate the use of the Conformable Gore TAG in TAAs. It has also been approved for investigation of endovascular repair of other etiologies including traumatic aortic transection and aortic dissection.

William Jordan, MD, will serve as the national principal investigator in the Conformable Gore TAG Device in TAA trial (Gore TAG 08-03), which will evaluate device performance across the complete portfolio of sizes available with the device. Device diameters range from 21 to 45 mm, and there are tapered devices. The study will investigate the treatment of patients with aortic diameters of 16 to 42 mm.

According to the company, the Conformable Gore TAG's design enhancements include a modified stent frame, repositioned gold bands, and optimized graft material. The commercially available Gore TAG thoracic endoprosthesis, which received FDA premarket approval in 2005 to treat aneurysms of the descending thoracic aorta, is composed of an expanded polytetrafluoroethylene graft with an outer self-expanding nitinol support structure to combine device flexibility and material durability.