Medtronic’s Assurant stent gets FDA nod

3 November 2011 (Last Updated November 3rd, 2011 03:30)

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.

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.