Boston Scientific announces expanded indication for CRE wire-guided
30 May 2012
Boston Scientific Corporation has announced FDA approval for
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
"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 stones," said Kenneth Sigman, MD, at Birmingham
Gastroenterology Associates in Birmingham, AL. "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."
"Large stone extraction with DASE is easy, procedures are
completed faster, and I have achieved a high rate of complete stone
clearance," said Riad Azar, MD, Barnes Jewish Hospital, St. Louis,
MO. "The technique is easy to learn, and I have taught a number of
referring physicians who are now doing it successfully."
"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," said David Pierce, president of the endoscopy
division at Boston Scientific. "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."
The CRE Wireguided Balloon Dilator is also indicated to dilate
narrowed areas (or strictures) in the digestive tract.
Source: Boston Scientific