Medtronic Receives FDA Marketing Clearance for Complete SE Biliary Stent System

Medtronic, Inc. (NYSE: MDT), announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the Complete SE (self-expanding) Biliary Stent System, which is indicated for use in the palliative treatment of malignant neoplasms in the biliary tree – 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.

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

The safety and effectiveness of this device in the vascular system have not been established.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.