Boston Scientific Corporation has announced it has received FDA clearance for expanded use indication for its CRE wire-guided balloon dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy, according to a news release.
The new indication allows physicians to perform dilation assisted stone extraction (DASE) with the CRE wire-guided balloon dilator. This approach may be considered as an alternative method for the removal of difficult stones in the biliary duct.
The CRE wire-guided balloon dilator is also indicated to dilate narrowed areas (or strictures) in the digestive tract.
"The CRE wire-guided balloon dilator for the DASE procedure provides a new and alternative endoscopic therapy for the more than 60 million people worldwide affected by the presence of stones in the common bile duct," said David Pierce, president of the endoscopy division at Boston Scientific, in the release. "The CRE wire-guided balloon dilator is a core product in our endoscopy portfolio, and it underscores our ongoing commitment to advancing treatments that meet the needs of patients and physicians."
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