FDA Clears Boston Scientific Spyglass DS System

Marlborough, Mass.-based Boston Scientific Corp has earned 510(k) clearance for its Spyglass DS direct visualization system used for cholangioscopy and pancreatoscopy procedures. Built on the technology of the original Spyglass System, the new Spyglass DS system is designed to optimize procedural efficiency and productivity with improved ease of setup, ease of use and image quality.

More than one million people worldwide undergo endoscopic retrograde cholangiopancreatography (ERCP) procedures each year to diagnose and treat diseases and conditions of the liver, gallbladder, pancreas and bile ducts. In the event that X-ray imaging is not sufficient to make a definitive diagnosis or therapeutic intervention requires direct visualization, cholangioscopy or pancreatoscopy may be performed. Cholangioscopy is the examination of the bile ducts using an endoscope to enable direct visualization of the biliary tree during ERCP while pancreatoscopy is the examination of the pancreatic ducts. Direct visualization of the bile and pancreatic ducts during ERCP can help obtain biopsy specimens, lead to the diagnosis of abnormalities, and guide stone therapy.

“I’m extremely pleased with the overall functionality of the new Spyglass DS system,” said Robert Hawes, M.D., FASGE, The Center for Interventional Endoscopy at Florida Hospital Orlando. “It was quick and easy to set up (‘plug and play’), the image quality and stability excellent and the four-way tip deflection intuitive. The system now enables endoscopists with ERCP expertise to perform cholangioscopy with or without intervention. My expectation is that this technology will increase our ability to diagnose and treat pancreatobiliary diseases and reduce the number of repeat ERCPs.”

Launched in 2007, the original Spyglass system helped re-establish cholangioscopy and pancreatoscopy as a valuable diagnostic and therapeutic procedure by allowing a single physician to perform the procedure as well as guide devices to examine, diagnose and treat conditions such as gallstones and suspected malignancies of the biliary tree and pancreas. The new Spyglass DS system builds on this technology with enhanced features to further improve visualization and help simplify the procedure. The system consists of a fully integrated Spyscope DS access and delivery catheter, and a single-use scope to eliminate probe reprocessing and image degradation over multiple uses. The integrated digital sensor provides superior imaging, far greater resolution and a 60 percent wider field of view than the first generation system. In addition, the Spyglass DS system offers physicians an integrated controller that fits on a standard ERCP cart for improved accessibility and ‘plug and play’ setup, helping to reduce procedure time, the company claims.

“Early detection is critical to improving outcomes in patients suffering from difficult pancreatico-biliary diseases, such as pancreatic cancer,” said David Pierce, senior vice president and president, Endoscopy, Boston Scientific. “The new Spyglass DS System can be performed as an extension of any ERCP procedure, enabling physicians to diagnose and treat more of their patients effectively and efficiently. Boston Scientific is proud to bring single-operator cholangioscopy to a new level of treatment.”