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™ Thoracic Stent Graft System
PMA Applicant: Medtronic Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: June 5, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf7/p070007a.pdf
What is it? The Talent™ Thoracic Stent Graft System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Thoracic 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 through the abdomen into the chest (near the heart) to bridge the site of the aneurysm in the aorta. The endovascular graft is then deployed (released) and self-expands to the diameter of the aorta, to exclude (seal off) the aneurysm and reline the artery wall. The other section of the endovascular graft is deployed into the aorta in the same fashion.
When is it used? The Talent™ Thoracic Stent Graft System is used instead of more invasive open surgery in patients who have a descending thoracic aortic aneurysm.
What will it accomplish? The Talent™ Thoracic Stent Graft System should benefit patients with a descending thoracic aortic aneurysm by preventing further growth and rupture of the aneurysm.
When should it not be used? The Talent™ Thoracic 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.
Additional information: The Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p070007