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: Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent)
Manufacturer: Cook Incorporated
Address: 750 Daniels Way, PO Box 489, Bloomington, IN 47402
Approval Date: April 4, 2012
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf2/p020018s040a.pdf
What is it? The Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) is an endovascular stent graft used to repair abdominal aortic aneurysms or aneurysms that involve both the abdominal aorta and iliac arteries (the large arteries that supply blood to the pelvis and legs).
An abdominal aortic aneurysm (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 tube-like device (a graft) is used within the blood vessel (endovascular) to treat the AAA by sealing it off.
The Zenith® Fenestrated AAA Endovascular Graft is made of a fabric tube supported by a metal framework. The fabric has carefully positioned holes to allow blood to continue to flow to the body's organs. The graft has three parts: an upper “main body”, a lower “main body” and one “leg.” 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 blood vessel. The adjunctive Zenith Alignment Stent is made of stainless steel and is used to help keep the holes in the graft lined up with the arteries that go to the organs.
How does it work? 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 in the groin where it is threaded through a blood vessel and advanced to the location of the aneurysm. The doctor uses a type of x-ray (fluoroscopy) to guide the graft. The graft is attached to the wall of the aorta by the self-expanding stents. Blood flow can then continue through the aorta without filling the aneurysm. This is intended to prevent further growth and possible rupture of the aneurysm.
Stents may be placed through the holes in the graft to help keep the blood flowing into the arteries that supply the organs.
When is it used? The Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) is used instead of an open (more invasive) surgery in patients who have a n abdominal aortic aneurysm or aneurysms that involve the aorta and the iliac arteries.
What will it accomplish? The Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) should benefit patients with an abdominal aortic aneurysm or aneurysms that involve the aorta and the iliac arteries by preventing further growth and rupture of the aneurysm.
When should it not be used? The Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) should NOT be used in patients:
- who have a condition that threatens to infect the graft
- who have sensitivities or allergies to the device materials or,
- who are unable to undergo the necessary preoperative and postoperative imaging and post-implantation studies.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
- NIH MedlinePlus - Aortic Aneurysm Repair - Endovascular
- NIH - MedlinePlus - Abdominal Aortic Aneurysm - Tutorial