FDA approves Cordis bilary stent system
Cordis has received 510(k) marketing clearance from the FDA for the S.M.A.R.T. Nitinol Stent Transhepatic Biliary System for lengths of 120 mm and 150 mm, which was announced at the at the 33rd annual scientific meeting of the Society of Interventional Radiology (SIR).
Cordis reported that while the 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, the safety and effectiveness of the device in the vascular system have not been established.
Available for the first time in the United States in the new lengths, the Miami Lakes, Fla.-based Cordis said that the stents have demonstrated accurate stent placement, which may decrease the need for additional stents to cover the full narrowing of the bile duct.
Cordis reported that while the 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, the safety and effectiveness of the device in the vascular system have not been established.
Available for the first time in the United States in the new lengths, the Miami Lakes, Fla.-based Cordis said that the stents have demonstrated accurate stent placement, which may decrease the need for additional stents to cover the full narrowing of the bile duct.