Boston Scientific (NYSE:BSX) said the FDA granted 510(k) clearance for the latest iteration in its line of cholangioscopy and pancreatoscopy devices, the SpyGlass DS.
Marlborough, Mass.-based Boston Scientific said the endoscope is designed to provide images of the biliary system in endoscopic retrograde cholangiopancreatography procedures when X-ray imaging isn’t sufficient.
"Early detection is critical to improving outcomes in patients suffering from difficult pancreatico-biliary diseases, such as pancreatic cancer," endoscopy president David Pierce said in prepared remarks. "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."
Boston Scientific said it 1st launched the SpyGlass device in 2007.
"I’m extremely pleased with the overall functionality of the new SpyGlass DS system," Dr. Robert Hawes of Florida Hospital Orlando added in a statement. "It was quick and easy to set up (‘plug and play’), the image quality and stability excellent and the 4-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."