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June 6, 2010
FDA Approves 45-mm Gore TAG Device
June 7, 2010—W. L. Gore & Associates (Flagstaff, AZ) announced that it has received approval from the US Food and Drug Administration (FDA) to market a 45-mm-diameter version of the Gore TAG thoracic endoprosthesis for treating aneurysms of the descending thoracic aorta. The larger-diameter device allows the treatment of thoracic aortic aneurysms with proximal and distal neck diameters ranging from 37 to 42 mm and is now available for commercial use in the United States. The FDA first approved the Gore TAG device in March 2005.
According to the company, the 45-mm TAG is available in 10-, 15-, and 20-cm lengths. Like other Gore TAG devices, the 45-mm version is delivered on a modified sheathless delivery catheter that is designed for enhanced trackability, deliverability, and flexibility for navigating tortuous anatomy and low deployment forces. It is composed of an expanded polytetrafluoroethylene graft with a self-expanding nitinol support structure.
“The availability of the 45-mm Gore TAG device will provide physicians treating thoracic aneurysms with more options,” commented Michel Makaroun, MD, who was the national principal investigator for the 45-mm Gore TAG device clinical study.
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