Healthcare Industry News:  Interventional Radiology 

Devices Interventional FDA

 News Release - March 17, 2008

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 Lengths

WASHINGTON--(HSMN NewsFeed)--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.

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular and gastroenterology technology. Through research, development and innovation, physicians worldwide are better able to treat the millions of patients who require interventional procedures. For more information about Cordis, please visit www.cordis.com.


Source: Cordis

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