GORE TAG® Thoracic Endoprosthesis
Traditional treatment of diseases of the thoracic aorta has involved high-risk surgery requiring a large incision in the chest to place a synthetic graft to repair the diseased artery. This method can result in long hospital stays and painful recoveries. Today, the medical community is seeking less invasive alternatives to this major open surgical approach.
The revolutionary GORE TAG® Thoracic Endoprosthesis means physicians now have a minimally invasive option for safely and effectively managing patients with aneurysms of the descending thoracic aorta. This time-tested, second generation endograft is the first approved thoracic stent-graft in the US.
The GORE TAG® Device has an elegantly simple design resulting from a decade of collaboration between physicians and scientists. It is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The function of the endoprosthesis is to internally reline the thoracic aorta and isolate the diseased segment from blood circulation.
The GORE TAG® Thoracic Endoprosthesis is inserted through a small incision in the patient's groin using a flexible catheter delivery system. This technique facilitates passage and access through narrow and tortuous aortic anatomies. Single sheath insertion eliminates the need for sheath re-insertion if additional devices are required.
In both clinical studies and real world commercial use, the GORE TAG® Thoracic Endoprosthesis has demonstrated a successful track record. Observed rates from the GORE TAG® Device US Pivotal Study demonstrated that the GORE TAG® Device group had lower operative paraplegia/paraparesis (3% vs. 14%), lower operative mortality (1% vs. 6%) and significantly less average procedural blood loss (472 ml vs. 2,402 ml) as compared to the open surgical control group.*
Additionally, through five years, subjects treated with the GORE TAG® Device had a consistently lower incidence of major adverse events (43% freedom from major adverse events in the Pivotal Study Test subjects vs. 21% in Pivotal Study Control subjects) and improved aneurysm-related survival (97.9% freedom from aneurysm-related death among Pivotal Study Test subjects vs. 90.4% for Pivotal Study Control subjects).
* See Instructions for Use or Annual Clinical Update for additional clinical data.
