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® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System (A prosthetic endovascular graft)
PMA Applicant: William Cook Europe, ApS
Address: Sandet 6, DK 4632, Bjaeverskov, Denmark
Approval Date: May 21, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf7/p070016a.pdf
What is it?The Zenith® TX2 ® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction 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 Zenith® TX2 ® Thoracic TAA Endovascular Graft is made of a fabric tube supported by a metal framework. Each endovascular graft is compressed into the end of an H&LB One-Shot™ Introduction System, 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 released (deployed) and self-expands to the diameter of the aorta, to exclude (seal off) the aneurysm and reline the artery wall. This can prevent further growth and possible rupture of the aneurysm.
When is it used? The Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System is used instead of more invasive open surgery in patients who have a descending thoracic aortic aneurysm.
What will it accomplish? The Zenith® TX2® Thoracic TAA Endovascular Graft 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 Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System 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=p070016