|The single-use SpyScope DS Catheter Tip--Courtesy of Boston Scientific|
Boston Scientific ($BSX) touted its new cleared endoscopic SpyGlass DS Direct Visualization System enabling direct visualization of the biliary tree and pancreatic ducts. With the FDA's 510(k) clearance now in hand, the device can hit the market.
The endoscope can be used when X-ray imaging is insufficient for diagnosis or when visualization is needed to guide the surgical procedure, such as to obtain biopsy samples, Boston Scientific says.
The SpyGlass DS is an upgrade over the previous version of SpyGlass, launched in 2007. Improvements include a single-use scope to eliminate the need for reprocessing, an integrated digital sensor that enhances the field of view by 60% and an easy-to-set-up device controller, according to the company.
The SpyGlass DS is for use during endoscopic retrograde cholangiopancreatography procedures for diagnosis and treatment of conditions of the liver, gallbladder, pancreas and bile ducts. Specific conditions treated using the surgery include gall stones and pancreatic cancer.
Boston Scientific says the device will reduce the number of repeat ERCPs performed.
"Early detection is critical to improving outcomes in patients suffering from difficult pancreatico-biliary diseases, such as pancreatic cancer," said the president of Boston Scientific's endoscopy division, David Pierce, in a statement. "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."
The company's explanatory video of the device says its catheter attaches to a duodenoscope for single-operator use. That's significant because the launch occurs in the context of growing safety concerns over duodenoscopes, which are implicated in spreading a class of fatal "superbug" pathogens.
The FDA is taking action to fix the growing problem. Note that the affected manufacturers of duodenoscopes appear to be Pentax Medical, Fujifilm Holdings and Olympus.
- read the release