Medtronic receives FDA clearance for biliary stent system

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Medtronic has received FDA 510(k) marketing clearance for the Complete self-expanding (SE) Biliary Stent System, for use in the palliative treatment of cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids.

The company said that U.S. commercial sales of the new biliary stent will begin immediately in a wide size range, with diameters of 4-10 mm and lengths of 20-150 mm.

Bench testing has shown the Complete SE Biliary Stent System to be extremely accurate in terms of stent placement which can decrease the likelihood that additional stents are necessary to cover the entire narrowing of the bile duct, according to the company.