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: Zenith® AAA Endovascular Graft (A prosthetic endovascular graft)
Manufacturer: Cook Incorporated
Address: 750 Daniels Way, Bloomington, Indiana 47404
Approval Date: May 23, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020018a.pdf
What is it and how does it work? The Cook Zenith® AAA Endovascular Graft (the graft) is a device used to treat an abdominal aortic aneurysm (AAA). An AAA is a bulge that occurs in the body’s largest artery -- the aorta -- as it passes through the abdomen. The bulge is caused by a weakening or thinning in the wall of the artery. A synthetic tubular device (a graft) is used within the vessel (endovascular) to treat the AAA by sealing it off.
The graft has three parts: a “main body” and two “legs.” It is made of a polyester material attached to a frame of stainless steel stents or scaffolds. The stents support the graft and hold it open within the vessel.
The graft is delivered to the aneurysm in the aorta by way of a long flexible delivery tube. The delivery tube containing the graft is inserted through a small incision (surgical cut) in the groin where it is threaded through a blood vessel and advanced to the location of the aneurysm. The doctor uses fluoroscopy (a type of X-ray) to guide the graft. The graft has several gold markers to help the doctor see the device during placement of the graft.
The graft is then attached to the wall of the aorta by the self-expanding stents and a specially designed attachment system. Once it is in place, blood flow can continue through the aorta without filling the aneurysm. This is intended to prevent further growth and possible rupture of the aneurysm. For a drawing of an AAA: http://www.nlm.nih.gov/medlineplus/ency/imagepages/18072.htm
When is it used? The Zenith® AAA Endovascular Graft may be used instead of the more invasive standard open surgery in certain patients who have an abdominal aortic aneurysm.
What will it accomplish? The Zenith® AAA Endovascular Graft 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, not all patients are candidates for treatment with an endovascular graft. The device should not be used in patients who are:
- unable to undergo the implantation and radiographic imaging studies necessary before and after implanting the graft.
- sensitive or allergic to the device materials.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020018