Medical Letter on the CDC & FDA
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Aortic Aneurysms
Panel recommends conditional approval of the TAG Thoracic Endoprosthesis
February 20th, 2005
W. L. Gore & Associates, Inc., (Gore), announced that its GORE TAG Thoracic Endoprosthesis received conditional approval for marketing clearance by the Circulatory System Devices Panel of the United States Food and Drug Administration (FDA). Gore is now 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. 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...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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