TAG THORACIC ENDOPROSTHESIS RECEIVES FDA ADVISORY PANEL RECOMMENDATION FOR CONDITIONAL APPROVAL

W. L. Gore announced that its Gore TAG Thoracic Endoprosthesis received conditional approval for marketing clearance by the Circulatory System Devices Panel of the FDA.

Gore is now uniquely positioned to provide the first endovascular device to U.S. patients with thoracic aortic aneurysms (TAA), a condition that can lead to rupture of the aneurysm and death. TAA treatment has traditionally necessitated highly invasive open surgery.

The FDA panel's conditional approval paves the way for the Gore TAG Thoracic Endoprosthesis to be used as an alternative to invasive open surgery, a procedure that is often associated with high complication rates such as paraplegia. The less invasive endovascular method allows the Gore TAG Device to be inserted through a small incision in the patient's groin.