Results of Spyglass Registry Presented at DDW

NATICK, Mass., and SAN DIEGO -- Boston Scientific Corporation announced that results from an international, multi-center patient registry documenting the safety and clinical utility of the SpyGlass® Direct Visualization System were presented at Digestive Disease Week® (DDW), which ran from May 17-22 in San Diego. Registry results were announced in three separate scientific oral presentations on Tuesday, May 20. In addition, a total of 15 abstracts on the clinical utility of the SpyGlass System were presented at the conference, underscoring its widespread acceptance in physician practices.

The SpyGlass patient registry reports on clinical data from 296 patients at 15 U.S. and European medical centers who required peroral cholangioscopy (PO) for the treatment or diagnosis of biliary stones or indeterminate strictures with suspected pathology.

The SpyGlass System is the first single-use direct visualization system that requires only a single 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 (ERC) procedures.

SpyGlass Patient Registry Presentations
Tuesday, May 20th
• Peroral Cholangioscopy Using a Disposable Steerable Single Operator Catheter for Biliary Stone Therapy and Assessment of Indeterminate Strictures – A Multi-Center Experience
Yang K. Chen, MD, division of gastroenterology and hepatology, University of Colorado at Denver and Health Sciences Center, and primary principal investigator of the SpyGlass registry, presented results that document the performance and utility of PO using the SpyGlass System over a 12-month period.

• Peroral Cholangioscopy Guided Stone Therapy – Report of an International Multi-Center Registry
Mansour Parsi, MD, department of gastroenterology and hepatology, The Cleveland Clinic Foundation, and principal investigator in the SpyGlass registry, will present results on a subset of patients that underwent PO using the SpyGlass System to determine its effectiveness in the treatment of difficult-to-remove biliary stones and assess its utility for the detection of missed stones by ERC.

• Biopsy of Indeterminate Biliary Strictures – Does Direct Visualization Help?
Kenneth F. Binmoeller, MD, Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, and principal investigator in the SpyGlass registry, will present results on a subset of patients with indeterminate biliary strictures or filling defects who underwent ERC followed by PO using the SpyGlass System and the SpyBite® Biopsy Forceps. The lead author of the analysis is Douglas Pleskow, MD, division of gastroenterology, Beth Israel Deaconess Medical Center, Boston, and principal investigator in the SpyGlass registry.

Source: Boston Scientific