Medtronic Gets FDA Clearance for New Stent

November 15, 2007

Medtronic has received 510(k) marketing clearance from the FDA for the Complete SE (self-expanding) Biliary Stent System.

The device is indicated for use in the treatment of cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids.

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, the company said.

Bench testing has shown the stent system to be accurate in terms of stent placement. The safety and effectiveness of this device in the vascular system have not been established.