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Medtronic Receives FDA Approval for Abdominal Stent Graft

by Astrid Fiano, DOTmed News Writer | April 23, 2008
The company's new
device repairs abdominal
aortic aneurysms
Medtronic's Talent™ Abdominal Stent Graft on the CoilTrac Delivery System has just been approved by the FDA to repair abdominal aortic aneurysms (AAA). The procedure is a minimally invasive treatment and repair offering significant advantages over surgery, and prevents further growth and/or rupture of an aneurysm with or without iliac involvement. The Talent™ Stent Graft System is comprised of a fabric tube supported by a metal framework. Each endovascular graft is compressed into the end of a long tube-like delivery catheter. The stent graft also has radiopaque markers for visual guidance during deployment and follow up.

The delivery catheter with the graft is inserted into an artery in the groin area through a small incision. Once guided in the artery into the site of the aneurysm, the graft is then released in the aorta where it will self-expand to the aorta's diameter and seal off the aneurysm.

The stent has a proximal aortic neck length requirement of only 10 mm, making endovascular repair accessible to an additional 20 percent of AAA patients. Estimates suggest over one million people in the United States have had an abdominal aortic aneurysm. Patients with AAA generally are asymptomatic until a rupture occurs. When the AAA patient is diagnosed, open surgical treatment is usually necessary due to the danger posed by weakening of the body's main artery. An inexpensive ultrasound screening test, covered by Medicare, can detect nearly all such aneurysms, which are responsible for about 15,000 annual deaths, particularly in older men.
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In Medtronic's clinical trials of the Talent™ stent, there were no aneurysm ruptures and no necessity for open surgery at 12 months after implantation. The patient participants in clinical studies experienced lower rates of death and fewer incidences of myocardial infarction, respiratory failure, and blood loss compared with open surgery patients.