FDA clears Gore TAG for endovascular repair of TAA

19 January 2012 (Last Updated January 19th, 2012 18:30)

The US Food and Drug Administration (FDA) has approved W. L. Gore & Associates's Conformable Gore TAG for endovascular repair of isolated lesions of the thoracic aorta, including traumatic aortic transections (TAA).

The US Food and Drug Administration (FDA) has approved W. L. Gore & Associates's Conformable Gore TAG for endovascular repair of isolated lesions of the thoracic aorta, including traumatic aortic transections (TAA).

The item is intended for multiple thoracic etiologies, and is currently part of an ongoing US trial for the treatment of acute dissection.

The device is specifically designed to treat the anatomy of young trauma patients, with the ability to be used on aortas as small as 16mm, while accommodating tapered anatomy and resisting compression.

Mark Farber , the principal investigator for the Conformable Gore TAG device in the Traumatic Aortic Transection Trial (Gore TAG 08-02), said: "Through the research, we were able to illustrate the capabilities of the Conformable GORE TAG Device, and help demonstrate that thoracic endografts can offer patients with traumatic aortic transection a less invasive alternative to open surgical repair."

The Gore TAG thoracic endoprosthesis is delivered via a catheter and inserted into the femoral artery through a small incision in the groin, then guided up the leg artery through the abdomen into the chest and to the site of the transection.

The device is available in 21-45mm diameters, allowing for the treatment of patients with aortic diameters of 16-42 mm.

Gore Aortic Business leader David Abeyta said the device can offer endovascular specialists and their patient's a minimally invasive treatment option for traumatic aortic transection. "The Conformable GORE TAG Device provides an optimal fit and maximum conformability for each patient's anatomy," he said.

A transection is a tear in the wall of the aorta, resulting in internal bleeding and is regularly fatal.

Gore Medical's range of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, as well as staple line reinforcement and sutures for use in vascular, cardiac and general surgery.