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: EXCLUDER™ Bifurcated Endoprosthesis (A prosthetic endovascular graft)
Manufacturer: W. L. Gore & Associates, Inc.
Address: 3450 West Kiltie Lane, Flagstaff, Arizona 86001
Approval Date: November 6, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020004a.pdf
What is it? The Gore EXCLUDER™ Bifurcated Endoprosthesis is a set of ePTFE grafts that a physician uses to repair an abdominal aneurysm in the main (aortic) artery where it branches into the two iliac arteries. An aneurysm is a diseased or weakened section of an artery wall that tends to balloon or bulge due to arterial blood pressure. Each graft in this device is housed in a long flexible delivery tube (catheter).
How does it work? First the physician inserts the Y-shaped graft into an incision in an artery in one leg, and threads it up until it is inside the aneurism. The physician then repeats this procedure with the second graft, using an artery in the other leg. When both grafts are inside the aneurism, they are attached to each other. The end of each graft has metal anchors that help hold it in place. Once the set of two grafts is in place inside the aortic aneurism and iliac arteries, blood flows through the aorta without filling the aneurysm. This can prevent further growth and possible rupture of the aneurysm. In some patients where the grafts need to be longer, the physician may add extension grafts that are similar to the second graft.
When is it used? The EXCLUDER™ Bifurcated Endoprosthesis is used in patients who have an abdominal aortic aneurysm when the more invasive open surgery is too risky.
What will it accomplish? The EXCLUDER™ Bifurcated Endoprosthesis should benefit patients with an abdominal 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 to be used in patients who are unable to undergo the necessary preoperative and postoperative imaging and implantation studies, or patients who are sensitive to, or allergic to the device materials.
Additional information: Summary of Safety and Effectiveness is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020004