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Multi-Center Patient Registry Supports Safety and Clinical Utility of Boston Scientific's SpyGlass(R) Direct Visualization System
Date:5/20/2008

ingle physician operator and provides four-way steerability in a four lumen single-use catheter. The catheter provides two dedicated irrigation channels in addition to a 1.2 mm working channel through which diagnostic and therapeutic devices can be used in the biliary ducts. The system includes a miniature 6,000-pixel fiber optic probe attached to a camera that provides physicians with a direct view of a patient's bile ducts, overcoming some of the visual challenges of conventional endoscopic retrograde cholangiography procedures (ERCP).

As part of the international multi-center SpyGlass registry, Mansour Parsi, M.D., Department of Gastroenterology and Hepatology at the Cleveland Clinic, also reported on clinical data from 98 patients, demonstrating that peroral cholangioscopy using the SpyGlass System is safe and effective for the treatment of difficult-to-remove biliary stones. In addition, Dr. Parsi concluded that the rate of missed stones by an ERCP may be higher than previously reported and more research is required.

An additional subset analysis from the patient registry, led by Douglas Pleskow, M.D., Director, Colon Cancer Center and Co-Director, GI Endoscopy at Beth Israel Deaconess Medical Center in Boston, involved 136 patients with indeterminate biliary strictures or filling defects who underwent an ERCP followed by peroral cholangioscopy using the SpyGlass System and the SpyBite Biopsy Forceps. The study results indicate that targeted biopsies using the SpyGlass System are feasible and safe, and provide specimens adequate for histology in 89 percent of cases. Preliminary results also show that biliary biopsies obtained under direct visualization by peroral cholangioscopy using the SpyBite Biopsy Forceps can be useful in selected clinical situations including histologic confirmation of malignant or benign intrinsic lesions of the bile duct. Patient follow-up for this registry is ongoing.

"This multi-center registry adds to the growing
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SOURCE Boston Scientific Corporation
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