Multi-Center Patient Registry Supports Safety and Clinical Utility of Boston Scientific's SpyGlass(R) Direct Visualizat...( Positive results presented at...),Health

Positive results presented at Digestive Disease Week(R) 2008

NATICK, Mass. and SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced results from an international, multi-center patient registry documenting favorable safety and clinical utility data for its SpyGlass(R) Direct Visualization System, which offers extensive visual access to the biliary tract. Results from the registry were presented by Yang K. Chen, M.D., Division of Gastroenterology & Hepatology, University of Colorado at Denver and Health Services Center and lead investigator, at Digestive Disease Week(R) (DDW) in San Diego. Two additional subset analyses from the SpyGlass patient registry were also presented at the conference.

The patient registry reports on clinical data from 296 patients at 15 medical centers (10 U.S. and 5 European sites) who required peroral cholangioscopy (PO) for stone therapy or investigation of suspected pathology with or without biopsy. Results of the study indicate that PO using the SpyGlass System can be safely performed by a single operator and provides reliable access to target sites for visual inspection and stone therapy. In addition, the SpyBite(R) Biopsy Forceps were found to obtain adequate histologic tissue specimens.

"The SpyGlass registry provides important information to physicians in assessing the safety and clinical effectiveness of the system," said Dr. Chen. "Preliminary results demonstrate that visual examination combined with directed tissue sampling using the SpyGlass System may improve accuracy of diagnosis in patients with indeterminate bile duct lesions."

The SpyGlass System is the first single-use direct visualization system that requires only a s
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