W. L. Gore & Associates, Inc. (Gore) has 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, although CE Mark approval for this indication dates back over two years.
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 in the USA prior to the approval.
The Conformable GORE TAG Thoracic Endoprosthesis is designed for multiple thoracic etiologies and gained FDA approval as recently as November 2011 for endovascular repair of thoracic aortic aneurysms. It already has CE mark approval, including for this new indication(dating back to 2009).
About the product
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 company claims 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.
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.
Dr. Mark Farber, principal investigator in the Traumatic Aortic Transection Trial stated; “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.”
“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.”
Source: W L Gore & Associates Inc
GORE®, TAG®, and designs are trademarks of W. L. Gore & Associates.