09.11.2011 – 07:03
Boston Scientific CRE? Wireguided Balloon Dilator CE Marked for Expanded Indication
Now available for endoscopic dilation of the Sphincter of Oddi following sphincterotomy
Boston Scientific Corporation's CRE(TM) 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(R) 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 Duesseldorf. "Our clinical experience is consistent with study findings that DASE is safe, effective and easy to employ. It reduces the need for mechanical lithotripsy and simplifies removal of larger stones or stone fragments."
"The new indication provides physicians an alternative method for treating patients requiring difficult stone extraction in the biliary duct, and demonstrates Boston Scientific's ongoing commitment to innovation and clinical science to expand endoscopic therapies available to physicians and patients," said David Pierce, President of Boston Scientific's Endoscopy Division. "The CRE Balloon has been a key offering in our Endoscopy product portfolio for more than 14 years and has helped solidify our market leadership."
The presence of stones in the common bile duct affects more than 61 million people worldwide, resulting in 800,000 therapeutic ERCP procedures each year. If not treated, the condition can cause biliary obstruction, infection, jaundice and liver damage.
In the U.S., the CRE Wireguided Balloon is not cleared for dilation of the Sphincter of Oddi following sphincterotomy.
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Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
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