FDA clears Boston Scientific endoscopic catheter

Boston Scientific has received 510(k) clearance from the FDA to market its SpyScope Access and Delivery catheter for diagnostic and therapeutic applications during endoscopic procedures of the pancreatico-biliary system.

The SpyScope catheter is used in conjunction with the SpyGlass Direct Visualization system, according to the Natick, Mass.-based company.

Previously available for use in the bile and hepatic ducts, the SpyGlass system can now be used to guide visualization and accessory devices throughout the pancreatico-biliary system, allow physicians to diagnose and treat pancreatic cancer or pre-cancerous tissues, Boston Scientific said.

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