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

FLAGSTAFF, Ariz.–(BUSINESS
WIRE)–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 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 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 patients 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. For more information, visit www.goremedical.com.

Posted by Sean Fenske, Editor-in-Chief, MDT