Medical equipment manufacturer Boston Scientific has received 510(k) approval from the US Food and Drug Administration (FDA) for its SpyGlass DS Direct Visualization System.


The new SpyGlass DS Direct Visualization System has been developed for cholangioscopy and pancreatoscopy procedures, which was based on the technology of the original SpyGlass System.

Cholangioscopy involves the examination of bile ducts using an endoscope to enable direct visualization of the biliary tree during ERCP, while pancreatoscopy is the examination of the pancreatic ducts.

Boston Scientific endoscopy senior vice-president and president David Pierce said: "Early detection is critical to improving outcomes in patients suffering from difficult pancreatico-biliary diseases, such as pancreatic cancer.

"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."

Introduced in 2007, the original SpyGlass System allowed single physician to perform cholangioscopy and pancreatoscopy procedures, 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 system further improves visualization and helps simplify the procedure, as it includes a fully integrated SpyScope DS Access and Delivery Catheter and a single-use scope to eliminate probe reprocessing and image degradation over multiple uses.

Image: SpyScope DS Catheter Tip. Photo: courtesy of Boston Scientific Corporation.