Gore Receives First FDA Approval for Endovascular Repair of Traumatic Aortic Transections

19 January 2012 (Flagstaff, Arizona)

Conformable GORE® TAG® Thoracic Endoprosthesis Designed for Endovascular Repair of the Descending Thoracic Aorta Provides Conformability without Compromise

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 US 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 at 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 through a small incision in the groin and carefully guided up the leg artery through the abdomen into the chest and to the site of the transection. 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.

“We are proud to deliver to endovascular specialists and their patients the first FDA approved minimally invasive treatment option for treating traumatic aortic transection,” said David Abeyta, Gore Aortic Business Leader. “The Conformable GORE TAG Device provides an optimal fit and maximum conformability for each patient’s anatomy.”

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 14th consecutive year.

Products listed may not be available in all markets. GORE®, TAG®, and designs are trademarks of W. L. Gore & Associates. AQ4875-EN1 JANUARY 2012