News | February 10, 2009

Gore Receives FDA Clearance for Modification to TAG Thoracic Endoprosthesis

February 10, 2009 - W. L. Gore and Associates today said at the annual International Congress of Endovascular Interventions XXII, it received FDA approval 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 company said. The hub component has also been modified to improve ease of use and durability.

The GORE TAG Thoracic Endoprosthesis is an option for less invasive treatment of TAA, an aneurysm of the descending thoracic aorta. 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.

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.

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