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Boston Scientific CRE™ Wireguided Balloon Dilator CE Marked for Expanded Indication
Date:11/9/2011

PARIS, November 9, 2011 /PRNewswire/ --

Now available for endoscopic dilation of the Sphincter of Oddi following sphincterotomy

Boston Scientific Corporation's (NYSE: BSX) CRE™ Wireguided Balloon Dilator is now CE marked for endoscopic dilation of the Sphincter of Oddi following sphincterotomy.  The new indication, which supplements the product's current indication for use in the alimentary (digestive) tract, lets physicians perform Dilation Assisted Stone Extraction (DASE), providing an alternative method to remove difficult stones in the biliary duct.

"DASE is a valuable technique to facilitate extraction of difficult-to-manage gallstones," said Prof. Marco Bruno, M.D., Professor of Gastrointestinal Oncology, Director of Gastroenterology & Endoscopy, Erasmus Medical Center, Rotterdam.  "This procedure should be considered as an option to treat large common bile duct stones, especially when conventional stone extraction fails or in challenging cases with anatomical variants.  When used appropriately, it has the potential to reduce the number of cumbersome and costly re-interventions."

Constructed of Pebax® material, the CRE Wireguided Balloon Dilator is designed to deliver three distinct, pressure-controlled diameters in a single balloon, allowing gradual dilation of strictures. The balloon's rounded-shoulder design is engineered to help facilitate endoscopic visualization or Balloon Endoscopy and provide greater usable balloon surface area during dilation.

"In our institution, DASE has become a routine intervention used to manage difficult bile stones," said Prof. Horst Neuhaus, M.D., Professor of Medicine, Head of the Department of Internal Medicine, Evangelisches Krankenhaus Düsseldorf.  "Our clinical experience is consistent with study findings that DASE is safe, effective and easy to employ. &
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