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: Talent™ Abdominal Stent Graft System (A prosthetic endovascular graft)
PMA Applicant: Medtronic Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403 USA
Approval Date: April 15, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf7/p070027a.pdf
What is it? The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Abdominal Stent Graft System is made of a fabric tube supported by a metal framework. Each endovascular graft is compressed into the end of a long, thin, tube-like device called a delivery catheter.
How does it work? The delivery catheter containing the endovascular graft is inserted into an artery in the groin through a small skin incision (cut). It is carefully guided within the artery into the abdomen to bridge the site of the aneurysm in the aorta. The endovascular graft is then released (deployed) in the aorta where it self-expands to the diameter of the aorta to exclude (seal off) the aneurysm and reline the artery wall. This endovascular graft goes from the aorta to the arteries that supply blood to one leg. Another delivery catheter containing an endovascular graft is inserted through a small skin incision on the other side of the groin. This endovascular graft connects the first endovascular graft with the arteries that go to the other leg.
When is it used? The Talent™ Abdominal Stent Graft System is used instead of more invasive open surgery in patients who have an abdominal aortic aneurysm.
What will it accomplish? The Talent™ Abdominal Stent Graft System should benefit patients with an abdominal aortic aneurysm by preventing further growth and rupture of the aneurysm.
When should it not be used? The Talent™ Abdominal Stent Graft should not be used in patients who have a condition that threatens to infect the graft or in patients with sensitivities or allergies to the device materials. In addition, the device should not be used in patients who are unable to undergo the necessary preoperative and postoperative imaging and implantation studies.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p070027