Medtronic has received US Food and Drug Administration (FDA) clearance for its Assurant cobalt iliac balloon-expandable stent system, designed to treat narrowed iliac arteries.
The approval is supported by the nine-month results from a trial that demonstrated technical, procedural and clinical success with the use of the Assurant stent.
Co-principal investigator William Gray said that the Assurant stent demonstrated good safety and long-term patency in the trial, with some of the lowest rates of nine-month target lesion revascularisation and target vessel revascularisation.
The new Medtronic stent uses a modular design to allow for smooth delivery to iliac artery lesions and conformability to the vessel wall.
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