Boston Scientific CRE? Wireguided Balloon Dilator CE Marked for Expanded Indication

Paris, November 9 (ots/PRNewswire) -

Now available for endoscopic dilation of the Sphincter of Oddi
following sphincterotomy

Boston Scientific Corporation's CRE(TM) Wireguided Balloon
Dilator is now CE marked for endoscopic dilation of the Sphincter of
Oddi following sphincterotomy. The new indication, which supplements
the product's current indication for use in the alimentary
(digestive) tract, lets physicians perform Dilation Assisted Stone
Extraction (DASE), providing an alternative method to remove
difficult stones in the biliary duct.

"DASE is a valuable technique to facilitate extraction of
difficult-to-manage gallstones," said Prof. Marco Bruno, M.D.,
Professor of Gastrointestinal Oncology, Director of Gastroenterology
& Endoscopy, Erasmus Medical Center, Rotterdam. "This procedure
should be considered as an option to treat large common bile duct
stones, especially when conventional stone extraction fails or in
challenging cases with anatomical variants. When used appropriately,
it has the potential to reduce the number of cumbersome and costly
re-interventions."

Constructed of Pebax(R) material, the CRE Wireguided Balloon
Dilator is designed to deliver three distinct, pressure-controlled
diameters in a single balloon, allowing gradual dilation of
strictures. The balloon's rounded-shoulder design is engineered to
help facilitate endoscopic visualization or Balloon Endoscopy and
provide greater usable balloon surface area during dilation.

"In our institution, DASE has become a routine intervention used
to manage difficult bile stones," said Prof. Horst Neuhaus, M.D.,
Professor of Medicine, Head of the Department of Internal Medicine,
Evangelisches Krankenhaus Duesseldorf. "Our clinical experience is
consistent with study findings that DASE is safe, effective and easy
to employ. It reduces the need for mechanical lithotripsy and
simplifies removal of larger stones or stone fragments."

"The new indication provides physicians an alternative method for
treating patients requiring difficult stone extraction in the biliary
duct, and demonstrates Boston Scientific's ongoing commitment to
innovation and clinical science to expand endoscopic therapies
available to physicians and patients," said David Pierce, President
of Boston Scientific's Endoscopy Division. "The CRE Balloon has been
a key offering in our Endoscopy product portfolio for more than 14
years and has helped solidify our market leadership."

The presence of stones in the common bile duct affects more than
61 million people worldwide, resulting in 800,000 therapeutic ERCP
procedures each year. If not treated, the condition can cause biliary
obstruction, infection, jaundice and liver damage.

In the U.S., the CRE Wireguided Balloon is not cleared for
dilation of the Sphincter of Oddi following sphincterotomy.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices whose products are used in a broad range
of interventional medical specialties. For more information, please
visit: http://www.bostonscientific.com.

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