Hospital Buyer

The S.M.A.R.T. Nitinol Stent Transhepatic Biliary System, designed by Cordis Corporation, has been granted marketing clearance by the Food and Drug Administration. News of the approval was printed by Smartbrief.

The system is indicated as a palliative treatment option for treat patients with malignant strictures of the biliary tree. Stricture can compromise patient’s digestion by impeding the low of digestive fluids. It is available in two different lengths: 120 and 150 mm. Patients have the stent placed via a Rapid Exchange Stent Delivery System.

The device is essentially similar to previously approved devices cited in the Cordis application for approval. This is the first time the device is available in these new lengths. Previous data on the device indicates that the stents are accurately placed. This minimizes the need for additional stents to be placed in the same location, covering the entire length of the bile duct.

Cordis is a Johnson & Johnson Company. This subsidiary specializes in the development of interventional technology for gastroenterology and vascular applications.

March 21, 2008 Related topics: Product Approval & Certification, Surgery, Gastroenterology