May 29, 2012
Boston Scientific Product Clears FDA Hurdle
By Rick Saia
Natick-based Boston Scientific said the U.S. Food and Drug Administration has approved expanded use of a product that can remove difficult stones in a patient's common bile duct.
The action by the FDA, called an "indication," allows doctors to perform a stone-removal procedure with the product, called the CRE Wireguided Balloon Dilator. The procedure is called dilation assisted stone extraction, or DASE. The dilator "provides a new and alternative endoscopic therapy for more than 60-million people worldwide (who are) affected by the presence of stones in the common bile duct," said David Pierce, president of Boston Scientific's endoscopy division.
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