Boston Scientific received FDA clearance to expand the use of the company’s CRE Wireguided Balloon Dilator to endoscopic dilation of the Sphincter of Oddi (aka sphincter of ampulla) following sphincterotomy, permitting Dilation Assisted Stone Extraction (DASE), an alternative method of purging stones in the biliary duct.
The dilator offers three pressure-controlled dilation sizes that can be set by the physician and is shaped to allow for easy placement, help with endoscopic visualization and for use in balloon endoscopy.
In the press release, Kenneth Sigman, M.D., at Birmingham Gastroenterology Associates in Birmingham, AL, is quoted as saying,
“Since becoming available, the DASE procedure with the CRE Wireguided Balloon has significantly changed my approach to the endoscopic removal of large common bile duct stones. It is an easy-to-use technique, and I have had great success in managing difficult stone. The CRE Wireguided Balloon is easy to place and is consistent and reliable for inflation size and pressure. I am very comfortable with this balloon for the DASE application as I’ve been using it for many years for esophageal and gastric stenosis.”