Medtronic's iliac stent nets FDA clearance

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The FDA has granted approval for Medtronic's Assurant Cobalt iliac balloon-expandable stent system.

The device features a balloon-expandable stent made from a cobalt-chromium alloy to be approved by the FDA for the treatment of narrowed iliac arteries. The iliac arteries branch off the aorta in the abdominal area and carry blood to downstream vessels that perfuse the pelvis, legs and feet.

The device’s FDA approval was supported by the nine-month results from the ACTIVE (Use of the Assurant Cobalt iliac stent system in the Treatment of Iliac Vessel Disease) trial, which examined the outcomes of 123 patients at 17 U.S. sites.