January 19, 2012 – W. L. Gore & Associates, Inc. (Gore) 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. The durable endoprosthesis is the first such device to receive approval for an indication that includes traumatic transection. The Conformable Gore Tag Thoracic Endoprosthesis is designed for multiple thoracic etiologies. Extensive clinical research has been conducted with the device in the areas of aneurysm and trauma, and there is an ongoing U.S. trial investigating its use for the treatment of acute dissection.
A transection is a tear in the wall of the aorta, typically the result of a motor vehicle accident, that causes internal bleeding and is frequently fatal. Open surgical repair was the only treatment option prior to the approval.
The Conformable Gore Tag Device is the only FDA-approved thoracic endoprosthesis specifically designed to treat the anatomy of young trauma patients, with the ability to treat down to 16 mm aortas and extremely tapered anatomy. 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 percent, allowing physicians to choose the appropriate oversizing for the patient anatomy.
Mark Farber, MD, Director of the Aortic Center at the University of North Carolina at Chapel Hill, served as national principal investigator for the Conformable Gore Tag Device in the Traumatic Aortic Transection Trial (Gore TAG 08-02). According to Dr. Farber, “We gained a great deal of insight and knowledge from the traumatic transection trial for Conformable GORE TAG Device that ultimately led to the expansion of indications. 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.”
The Conformable Gore Tag Thoracic Endoprosthesis is delivered via catheter and inserted into the femoral artery. The device is available in diameters of 21-45 mm, allowing for the treatment of patients with aortic diameters of 16-42 mm. Tapered device configurations are also available.