Boston Scientific said the system has been installed in approximately 600 medical facilities worldwide and used globally in more than 25,000 patient procedures.
The SpyGlass Direct Visualization System was developed to overcome limitations of traditional cholangioscopes and ERCP (endoscopic retrograde cholangio-pancreotography) while reducing the need for exploratory surgery, potentially reducing cost and procedure time.
The SpyGlass System features a miniature 6,000-pixel fiber optic probe attached to a camera that permits direct visualization of the pancreatico-biliary system.
Using dedicated irrigation and working channels, physicians can sample diagnostic tissues within the bile duct using the disposable SpyBite Biopsy Forceps and deliver therapeutic devices, such as electrohydraulic lithotripsy (EHL) or laser probes, to break up large stones.
Boston Scientific also announced results of an international, multi-center registry of 297 patients who underwent cholangioscopy for stone therapy or investigation of suspected pathology with the SpyGlass System.
Results showed targeted biopsies using the SpyGlass System with SpyBite Forceps provided specimens adequate for histology in 89% of cases.
Results also demonstrated a 92% success rate in large stone management procedures.
The company has completed compatibility testing with the Lumenis SlimLine GI Fiber 365 micron laser probe and the Northgate EHL probe, which allows the SpyGlass System to be used during ERCP for laser or EHL stone ablation procedures within the bile ducts, expanding the product’s functional capabilities.
