Cordis Corporation Receives U.S. Food and Drug Administration Clearance for S.M.A.R.T. Nitinol Stent Transhepatic Biliary System for 120 mm and 150 mm

WASHINGTON - (Business Wire) Cordis Corporation announced today at the 33rd Annual Scientific Meeting of the Society of Interventional Radiology meeting it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System for lengths of 120 mm and 150 mm. These stents are indicated for use in the palliative treatment of malignant strictures in the biliary tree that can restrict the flow of digestive fluids and compromise digestion.
Available for the first time in the US in the new lengths, the stents have demonstrated accurate stent placement, which may decrease the need for additional stents to cover the full narrowing of the bile duct. The safety and effectiveness of this device for use in the vascular system have not been established.