Boston Scientific Announces Expanded Indication For CRE Wireguided Balloon Dilator

Indication Provides New Therapeutic Option for Extraction of Difficult-to-Manage Biliary Stones


May 30, 2012

Boston Scientific Corp. announces the U.S. Food and Drug Administration has cleared an expanded use indication for the CRE Wireguided Balloon Dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy.  The new indication offers physicians the ability to now perform Dilation Assisted Stone Extraction (DASE) with the CRE Wireguided Balloon Dilator.  This is an alternative method for the removal of difficult stones in the biliary duct.

The CRE Wireguided Balloon Dilator is constructed of Pebax to provide durability and flexibility, and is designed to gradually open strictures by delivering three distinct pressure-controlled diameters in a single balloon. The rounded-shoulder design of the balloon is engineered to help facilitate endoscopic visualization or balloon endoscopy and provide greater usable balloon surface area during dilation.

The CRE Wireguided Balloon Dilator is also indicated to dilate narrowed areas (or strictures) in the digestive tract.

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