Medtronic Wins FDA Approval for New Device

Medtronic is expanding its products for endovascular aortic repair in the U.S. with two new devices: the FDA-approved Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA 510(k)-cleared Sentrant Introducer Sheath.

The company today announced it had recently received "first-of-its-kind FDA approval" for the Endurant system.

When a weak area of the abdominal aorta bulges, it is called an abdominal aortic aneurysm (AAA), a potentially fatal condition. An endovascular stent graft is a fabric tube supported by a metal mesh stent. The stent graft creates a tight seal with the artery wall above and below the aneurysm, allowing blood to pass through without causing the artery to bulge further and risking a potentially fatal hemorrhage.

The Sentrant Introducer Sheath enables passage of the stent graft delivery system to the aneurysm repair site. Meanwhile, Medtronic's AUI Stent Graft System is now the only FDA-approved AUI device in the United States for the primary treatment of aortic aneurysms below the level of the kidneys, or for aneurysms in the region where the aorta splits into the two iliac arteries. It allows for repair of a single branch of the iliac artery.

Previously, access to both arteries was necessary.

Current global usage of the AUI stent graft configurations averages 5% for intact aneurysms and 39% for ruptured aneurysms, according to Medtronic. This new product should push those numbers upward significantly.


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