Conformable Gore TAG Studied for Traumatic Thoracic Transections

January 7, 2010—W. L. Gore & Associates (Flagstaff, AZ) announced that the first human implants in the United States of the next-generation Conformable Gore TAG thoracic endoprosthesis for treating traumatic transection of the thoracic aorta were conducted under an investigational device exception from the US Food and Drug Administration (FDA). Mark Farber, MD, is serving as the national principal investigator for the Conformable Gore TAG device traumatic aortic transection trial (Gore TAG 08-02). The device is limited to investigational use by United States law, the company advised.

“We hope to gain insight and knowledge from this trial that will not only illustrate the Gore TAG device's capabilities but will also help show that thoracic endografts can offer patients with traumatic aortic transection a less-invasive alternative,” commented Dr. Farber.

According to the company, the next-generation Conformable Gore TAG device has also been approved to investigate its efficacy for endovascular repair of other etiologies, including thoracic aortic aneurysms and aortic dissections. The commercially available first-generation Gore TAG device received premarket approval from the FDA in 2005 as a minimally invasive option for safely and effectively treating patients with descending thoracic aortic aneurysms.