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FDA approves Medtronic Assurant Cobalt Stent System

The US Food and Drug Administration (FDA) has approved Medtronic's Assurant Cobalt Iliac Balloon-Expandable Stent System to treat narrowed iliac arteries.

The stent system is built with a cobalt-chromium alloy and features ultrathin, round, edgeless struts for smooth delivery to iliac artery lesions and conformability to the vessel wall without sacrificing radial strength.

The design features enable the stent to utilize a 6F sheath for the entire size matrix from the smallest (6mm x 20mm) to the largest (10mm x 60mm) size.

The approval was based on positive nine-month results from the the Assurant Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease (ACTIVE) trial.

ACTIVE co-principal investigator and New York Presbyterian Hospital MD William Gray said the Assurant Cobalt stent demonstrated excellent safety and long-term patency in the prospectively conducted and core lab controlled ACTIVE trial, with some of the lowest rates of 9-month TLR ever seen in an iliac interventional trial.