Medtronic Releases New AAA Stent Graft in U.S. and Europe

Minneapolis, Minn.-based Medtronic Inc. has released its Endurant IIs AAA (abdominal aortic aneurysm) stent graft, which recently earned CE mark and U.S. Food and Drug Administration approval, in Europe and the United States. The new device joins the Endurant family of products, which according to the company have been used to treat more than 160,000 patients worldwide since they were first introduced in Europe in 2008.

The Endurant IIs stent graft is a new bifurcated component for a system based on a predicate device, and expands the system’s anatomical customization options. The new device is designed to be used as part of a three-piece configuration.

“Every AAA patient has different anatomical features, which is why it’s so important for a stent graft system to provide for a wide variety of anatomical customization options,” explained William Jordan Jr., M.D., professor of surgery and chief of vascular surgery and endovascular therapy at the University of Alabama Birmingham. ”The Endurant stent graft system sets the standard for configuration possibilities, and the addition of the Endurant IIs stent graft expands the possibilities even further.”

“The new Endurant IIs stent graft gives a winning idea new legs,” added Professor Hence Verhagen, M.D., Ph.D., chief of vascular surgery at the Erasmus Medical Center in Rotterdam, the Netherlands. ”It stands to broaden the already broad appeal of the Endurant system, especially for physicians who prefer a three-piece configuration for endovascular aneurysm repair.”

Affecting an estimated 2.5 million people in the United States and Western Europe, an abdominal aortic aneurysm, or AAA, is a potentially dangerous bulge in the body’s main artery where it traverses the mid-section. Those with a diameter of 5.5 centimeters, or twice the diameter of the patient’s normal abdominal aorta, typically warrant treatment. Outside a hospital setting, a ruptured AAA usually results in death.

A stent graft is a tubular medical device that creates a new path for blood flow through the diseased segment of the aorta, thereby reducing pressure on the aneurysm and the risk of rupture. It consists of a wire frame (stent) that is sewn onto a specially woven fabric (graft).

The bifurcated component in a stent graft system for AAA repair resembles a pair of pants with uneven legs. The top of the bifur fits the inner diameter of the aorta, while the “legs” fit the inner diameter of the iliac arteries, which branch off from the lower end of the aorta. The legs are different lengths to facilitate the implant procedure. They accommodate “limbs” that extend into the iliac arteries. The limbs are extensions of the legs.