GORE® TAG® Thoracic Branch Endoprosthesis Gains FDA Approval
Gore and Associates recently announced U.S. approval by the Food and Drug Administration (FDA) for the GORE® TAG® Thoracic Branch Endoprosthesis (TBE). This device is indicated for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery. This is for patients who have adequate iliac/femoral access, and eligible proximal aorta, left subclavian or distal landing zones (isolated lesion patients only). This approval is supported by data from the pivotal study including 238 patients of varying conditions of the descending thoracic aorta, to evaluate the safety and effectiveness of the TBE in treating lesions of the aortic arch and descending thoracic aorta.
According to GORE’s press release: “As the first flexible, off-the-shelf single branch thoracic endoprosthesis for the aortic arch, the TBE Device combines the proven conformability and durability of the Conformable GORE® TAG® Device with the ability to endovascularly perfuse the left subclavian artery,” said Eric Zacharias, Medical Products Division Leader at Gore. “This approval is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market.”
