FDA Clears Boston Scientific's SpyScope(R) Access and Delivery Catheter for Use in Endoscopic Procedures Throughout Pancreatico-Bili...( SpyGlass(R) Direct Visualization Syst...)

SpyGlass(R) Direct Visualization System can now be used for diagnostic and therapeutic procedures for pancreatic disease

NATICK, Mass., May 28 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SpyScope(R) Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system. The SpyScope Catheter is used in conjunction with the SpyGlass(R) Direct Visualization System. Previously available for use only in the bile and hepatic ducts, the SpyGlass System can now be used to guide visualization and accessory devices throughout the entire pancreatico-biliary system, enabling physicians to diagnose and treat pancreatic cancer or pre-cancerous tissues.

According to the American Cancer Society, in 2008 nearly 38,000 Americans were diagnosed with cancer of the pancreas -- the fourth-leading cause of cancer death in the U.S. Pancreatic cancer is a "silent" disease, with patients often not exhibiting symptoms until late in the disease process. As a result, the majority of patients with late-stage disease have a poor prognosis for survival.

"Early detection is critical to improving outcomes in patients with pancreatic cancer, but the 'silent' nature of the disease -- coupled with the inadequate diagnostic options of traditional x-ray or surgery -- have historically made this very difficult," said Douglas Pleskow, M.D., Beth Israel Deaconess Medical Center, Boston. "The SpyGlass System represents a tremendous advance in both the diagnosis and treatment process of pancreatic disease. With SpyGlass, I can navigate the ducts seamlessly, visualize the areas of interest and deliver treatment. In addition, I can use complementary
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