Multi-center Patient Registry Supports Safety, Utility of Boston Scientific's Spyglass System

NATICK, Mass., and SAN DIEGO -- Boston Scientific Corporation announced results from an international, multi-center patient registry documenting favorable safety and clinical utility data for its SpyGlass® Direct Visualization System, which offers extensive visual access to the biliary tract. Results from the registry were presented by Yang K. Chen, MD, division of gastroenterology & hepatology, University of Colorado at Denver and Health Services Center and lead investigator, at Digestive Disease Week® (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® 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 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 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 procedures (ERCP).

As part of the international multi-center SpyGlass registry, Mansour Parsi, MD, 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, 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, MD, 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 body of evidence that supports the benefits of the SpyGlass System for single-operator duodenoscope-assisted cholangiopancreatoscopy in performing diagnostic and therapeutic endoscopic procedures such as targeted biopsies and the management of biliary stones," said Michael P. Phalen, president, Boston Scientific Endoscopy. "The SpyGlass System is making cholangioscopy feasible for physicians worldwide and improving the quality of healthcare for patients."

Source: Boston Scientific