FDA Approves Conformable Gore TAG to Treat Traumatic Aortic Transections

January 19, 2012—Gore & Associates (Flagstaff, AZ) announced that the US Food and Drug Administration (FDA) has approved the Conformable Gore TAG thoracic endoprosthesis for endovascular repair of isolated lesions of the descending thoracic aorta, including traumatic aortic transections.

According to the company, the Conformable Gore TAG device is designed to treat multiple thoracic etiologies, including young trauma patients. The device's broad oversizing window ranges from 6% to 33%, which allows interventionists to choose the appropriate oversizing for each patient's 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 stated.

Mark Farber, MD, served as national Principal Investigator for the Gore TAG 08-02 trial of the Conformable Gore TAG device in the traumatic aortic transection.

“We gained a great deal of insight and knowledge from the traumatic transection trial for the Conformable Gore TAG device that ultimately led to the expansion of indications," commented Dr. Farber. "Through the research, we were able to illustrate the capabilities of the Conformable Gore TAG device and help to demonstrate that thoracic endografts can offer patients with traumatic aortic transection a less invasive alternative to open surgical repair.”