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FDA Grants 510(k) Clearance To Boston Scientific’s SpyScope Access And Delivery Catheter For Use In Endoscopic Procedures

Boston Scientific Corporation announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its SpyScope 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 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 US 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 technologies such as electrohydraulic lithotripsy (EHL) and lasers for stone ablation inside the biliary and hepatic ducts.

Until the introduction of the SpyGlass System, direct visualization of the pancreatico-biliary system was not widely performed, due to the significant limitations of traditional cholangioscopy systems. For many patients, exploratory surgery has been the only practical way to secure a diagnosis.

The SpyGlass Direct Visualization System is a single-operator system developed to overcome the limitations of traditional cholangioscopy systems and reduce the need for exploratory surgery. The SpyGlass System is designed to enable physicians to directly visualize the target site, obtain a diagnostic tissue sample with the disposable SpyBite Biopsy Forceps, and deliver therapies such as laser and EHL.

Being able to diagnose pancreatic disease without the need for an invasive surgical procedure represents significant progress, said Michael Phalen, President, Boston Scientific Endoscopy. With a more timely diagnosis, patients can begin treatment much earlier, resulting in the potential to dramatically improve outcomes. Physicians are already making the SpyGlass System an integral part of their practice, and they can now leverage this visualization technology across the entire pancreatico-biliary system to improve the quality of patient care. We are confident the SpyGlass System will be an important tool in the diagnosis and treatment of a broad range of diseases, most notably pancreatic cancer.

The upcoming Digestive Disease Week 2009 Conference will feature 14 abstracts on the clinical utility of the SpyGlass System in evaluating and treating pancreatic disease.