W. L. Gore & Associates, Inc. Receives FDA Approval for Modification to GORE TAG(R) Thoracic Endoprosthesis

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today announced at the annual International Congress of Endovascular Interventions XXII, that it has received approval from the US Food & Drug Administration (FDA) to market a modified version of the GORE TAG Thoracic Endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The improved delivery catheter enhances the previous version of the GORE TAG Thoracic Endoprosthesis by adding a soft flexible tip to the leading end of the delivery system. The soft tip improves flexibility at the wire / catheter interface to facilitate tracking through challenging aortic anatomy. The hub component has also been modified to improve ease of use and durability.

In North America, the GORE TAG Thoracic Endoprosthesis is the leading option for less invasive treatment of TAA, an aneurysm of the descending thoracic aorta, the body’s main circulatory vessel. TAA is a life-threatening condition generally believed to be significantly under-diagnosed, and patients with TAA are at risk of death due to internal bleeding resulting from a ruptured aorta. The GORE TAG Thoracic Endoprosthesis is also the only thoracic device with more than 10 years of worldwide clinical data. It was first approved by the FDA in March 2005 and has been granted regulatory approval in Europe, Japan and South Korea. Gore has already begun distribution of the upgraded delivery system, and plans to have this completed across the U.S. within the next few months.

David Abeyta, associate with the Gore Aortic Products Business stated, “The modification of the GORE TAG Thoracic Endoprosthesis builds on Gore’s reputation for bringing high quality, innovative technology to the medical community. We look forward to even better patient and physician results through this improved delivery system.”

The GORE TAG Thoracic Endoprosthesis internally relines the thoracic aorta and isolates the diseased segment from blood circulation. The GORE TAG Thoracic Endoprosthesis is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted by a catheter delivery technique through a small incision in the patient’s groin.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 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 12th consecutive year. For more information, visit http://www.goremedical.com.

GORE, TAG®, and designs are trademarks of W. L. Gore & Associates. AN0041-EN1

Contact:

Schwartz Communications, Inc. for W. L. Gore & Associates Shannon Murphy or Andrea Hawley, 415-512-0770 GoreMedical@schwartz-pr.com

Source: W. L. Gore & Associates