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Boston Scientific Announces CE Mark Approval for Expanded Indication of WallFlex® Biliary RX Stent
Date:10/22/2010

NATICK, Mass., Oct. 22 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced that its WallFlex® Biliary RX Fully Covered Stent has received CE Mark approval for the treatment of benign biliary strictures.  

"The WallFlex Biliary RX Fully Covered Stent has proved effective in the management of malignant biliary strictures, and I'm pleased that physicians in Europe and other CE Mark countries can now use this stent to treat benign biliary strictures," said Professor Jacques Deviere, M.D., Ph.D., Hopital Erasme in Brussels.  "The WallFlex Stent incorporates the latest innovations in self-expanding metal stent technology and may provide significant benefits as a less-invasive alternative to surgery in these patients."

"This new indication gives me the confidence to perform what I have found to be the most effective therapy – metal stent placement – during the initial ERCP(1) procedure in patients where previously I would have waited for a confirmed diagnosis of the stricture," said Adrian Hatfield, M.D., University College London Hospital.  "It may help to reduce the number of procedures my patients must undergo, while containing costs and providing the best possible care."

The WallFlex Biliary RX Stent is constructed of braided, Platinol™ (platinum-cored Nitinol) wire and features three key attributes: radial force to help maintain duct patency and resist migration, flexibility to aid in conforming to tortuous anatomies, and full-length radiopacity to enhance stent visibility under fluoroscopy.  The WallFlex Biliary RX family of stents is available in fully covered, partially covered and uncovered versions.  The covered stents have a silicone polymer Permalume® coating designed to reduce the potential for tumor/tissue ingrowth, and an integrated retrieval loop for removing or repositioning the
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