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 Data (SSED) 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
Manufacturer: W.L. Gore & Associates, Inc.
Address: 3450 W. Kiltie Lane, Flagstaff, AZ 86001
Approval Date: September 10, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf4/p040043s051a.pdf
What is it? The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat all isolated lesions of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include aneurysms, transections and dissections. An aneurysm is a diseased, bulging, weak section of an artery wall; in this case it’s the aorta. A transection is a rupture or tear of the aortic wall, typically resulting from blunt force trauma. A dissection is a serious condition where the inside lining of the aorta tears away from the outer wall.
The GORE TAG Thoracic Endoprosthesis is made of expanded polytetrafluoroethylene (ePTFE), with an outer metallic support structure known as a stent. Each endovascular stent 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 stent grafting system approved to treat all lesions, including dissections, of the descending thoracic aorta. Approval of the broad indications was based on the addition of information from a clinical study of the highest risk type of dissection with the previously provided data from clinical studies of aneurysms and transections.
How does it work? The delivery catheter containing the endovascular stent graft is inserted into the femoral artery in the groin through a small incision. It is carefully guided within the artery into the descending thoracic aorta to bridge the site of the lesion. The endovascular stent graft is then released (deployed) and the stent self-expands to the diameter of the aorta. The endovascular stent graft redirects blood flow away from the lesion and it relines the artery wall. This can prevent further growth and possible rupture of the aorta, or prevent the severe bleeding from a transection.
When is it used? The GORE TAG Thoracic Endoprosthesis is used instead of an open (more invasive) surgery in patients who have lesions of the descending thoracic aorta. This supplement expands the indication for use to include dissections.
What will it accomplish? The GORE TAG Thoracic Endoprosthesis should benefit patients with an isolated lesion in the aorta in the chest by preventing further growth and rupture of the lesion. If the device doesn't completely seal off the lesion from pressurized blood flow, there is a chance that additional treatment will be needed to prevent these problems.
When should it not be used? The GORE TAG Thoracic Endoprosthesis should not be used in patients who are unable to undergo the necessary preoperative and postoperative imaging and implantation studies, patients who have an infection that might threaten to infect the endovascular stent graft, and in patients who are sensitive to, or allergic to the device materials.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.