This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: GORE TAG Thoracic Endoprosthesis (A prosthetic endovascular graft)
Manufacturer: W. L. Gore & Associates, Inc.
Address: 3450 West Kiltie Lane, Flagstaff, Arizona 86001
Approval Date: March 23, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040043a.pdf
What is it? The GORE TAG Thoracic Endoprosthesis is used to repair aneurysms of the aorta in the chest (thoracic aorta). An aneurysm is a diseased, weakened and bulging section of an artery wall. The GORE TAG Thoracic Endoprosthesis is an endovascular graft made of ePTFE (expanded polytetrafluoroethylene), with an outer metallic support structure known as a stent. Each endovascular graft is compressed into the end of a long, thin, tube-like device called a delivery catheter.
The GORE TAG Endoprosthesis is the first endovascular grafting system approved to treat aneurysms of the thoracic aorta.
How does it work?
- The delivery catheter containing the endovascular graft is inserted into an artery in the groin through a small surgical cut in the skin (incision).
- It is carefully guided within the artery through the abdomen into the chest (near the heart) to bridge the site of the aneurysm in the aorta.
- The endovascular graft is then released (deployed) and self-expands to the diameter of the aorta, to seal off (exclude) the aneurysm and reline the artery wall. This can prevent further growth and possible rupture of the aneurysm.
When is it used? The GORE TAG Thoracic Endoprosthesis is used instead of more invasive open surgery in patients who have a descending thoracic aortic aneurysm.
What will it accomplish? The GORE TAG Thoracic Endoprosthesis should benefit patients with a descending thoracic aortic aneurysm by preventing further growth and rupture of the aneurysm.
When should it not be used? Although there are no known contraindications for use, the device should not be used in patients who are
- unable to undergo the necessary preoperative and postoperative imaging and implantation studies
- sensitive to, or allergic to the device materials
The Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040043