The US Food and Drug Administration (FDA) has cleared the expanded use indication of Boston Scientific's CRE Wireguided Balloon Dilator.
The new indication facilitates physicians to perform dilation assisted stone extraction (DASE) of the Sphincter of Oddi, following sphincterotomy.
The CRE Wireguided Balloon Dilator is made of Pebax and is designed to open strictures by delivering three distinct pressure-controlled diameters in a single balloon.
Boston Scientific endoscopy division president David Pierce said the CRE Wireguided 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.
"The CRE Wireguided 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," Pierce added.
The CRE Wireguided Balloon Dilator is also indicated to dilate narrowed areas in the digestive tract.