The SpyGlass DS Direct Visualization System was designed to build on the existing feature set and expand the procedural opportunities for diagnostic and therapeutic cholangioscopy and pancreatoscopy
by offering improvements over the current platform--namely ease-of-setup, ease-of-use, image quality and illumination.
Food and Drug Administration 510(k) clearance of its next-generation SpyGlass DS Direct Visualization System used for cholangioscopy and pancreatoscopy procedures.
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.
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.
NYSE: BSX) has received 510(k) clearance and the first cases of the SpyGlass DS Direct Visualization System used for cholangioscopy and pancreatoscopy procedures, the company said on Thursday.
In the event that x-ray imaging is not sufficient to make a definitive diagnosis or therapeutic intervention requires direct visualisation, 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.
B: SpyGlass pancreatoscopy
revealed whitish-green surgical wire in main duct.
A new endoscopic method: the peroral choledocho- pancreatoscopy