Fridley-based Medtronic Inc. Monday announced its latest medical device approval from the U.S. Food and Drug Administration. The FDA gave Medtronic approval to market and sell it's Assurant Cobalt Iliac Balloon-Expandable Stent System in the United States. The new device features the first balloon-expandable stent made from a cobalt-chromium alloy for the treatment of narrowed iliac arteries.
The iliac arteries branch off from the aorta in the abdomen carrying blood to the pelvis, legs and feet. By using the cobalt chromium alloy, Medtronic is able to create a device that is ultra-thin and round without sacrificing strength. The FDA approval was supported by a medical trial that examined 123 patients at 17 U.S. sites.
The Assurant Cobalt stent system compliments Medtronic's self-expanding Complete SE Vascular stent, which had received prior approval for use on iliac arteries.
Patrick Kennedy • 612-673-7926
