FDA approvals

FDA approves next generation SpyGlass DS for pancreaticobiliary diseases

The FDA has granted 510(k) clearance to the SpyGlass DS Direct Visualization System for cholangioscopy and pancreatoscopy procedures, updated from the original model to improve ease of setup, ease of use and image quality, the manufacturer announced.

“I’m extremely pleased with the overall functionality of the new SpyGlass DS,” Robert Hawes, MD, FASGE, from the Center for Interventional Endoscopy at Florida Hospital in Orlando, said in the press release from Boston Scientific. “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 [endoscopic retrograde cholangiopancreatography (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.”

The original model was launched in 2007, and by enabling a single physician to perform cholangioscopy and pancreatoscopy and guide devices, helped to re-establish the procedures as valuable diagnostic and therapeutic tools, the release said. The new model offers improved visualization and a simplified procedure. The system includes a fully integrated SpyScope DS Access and Delivery Catheter, a single-use scope eliminates the need for probe reprocessing and prevents image degradation over time, an integrated digital sensor with improved imaging and resolution and a 60% wider field of view, and an integrated controller that fits on a standard ERCP cart, the release said.

“Early detection is critical to improving outcomes in patients suffering from difficult pancreatico-biliary diseases, such as pancreatic cancer,” David Pierce, senior vice president of Endoscopy at Boston Scientific, said in the release. “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."

The FDA has granted 510(k) clearance to the SpyGlass DS Direct Visualization System for cholangioscopy and pancreatoscopy procedures, updated from the original model to improve ease of setup, ease of use and image quality, the manufacturer announced.

“I’m extremely pleased with the overall functionality of the new SpyGlass DS,” Robert Hawes, MD, FASGE, from the Center for Interventional Endoscopy at Florida Hospital in Orlando, said in the press release from Boston Scientific. “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 [endoscopic retrograde cholangiopancreatography (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.”

The original model was launched in 2007, and by enabling a single physician to perform cholangioscopy and pancreatoscopy and guide devices, helped to re-establish the procedures as valuable diagnostic and therapeutic tools, the release said. The new model offers improved visualization and a simplified procedure. The system includes a fully integrated SpyScope DS Access and Delivery Catheter, a single-use scope eliminates the need for probe reprocessing and prevents image degradation over time, an integrated digital sensor with improved imaging and resolution and a 60% wider field of view, and an integrated controller that fits on a standard ERCP cart, the release said.

“Early detection is critical to improving outcomes in patients suffering from difficult pancreatico-biliary diseases, such as pancreatic cancer,” David Pierce, senior vice president of Endoscopy at Boston Scientific, said in the release. “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."