Studies to be presented on safety and efficacy of SpyGlass System for diagnostic and therapeutic procedures throughout pancreatico-biliary system
NATICK, Mass., May 28 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that 14 abstracts and additional clinical data analyses involving the SpyGlass(R) Direct Visualization System will be presented at Digestive Disease Week(R) (DDW), which runs from May 30 to June 4 in Chicago.
"The impressive number of presentations on the SpyGlass System underscores the potential of this technology as a vital new tool in endoscopic procedures for diagnosing and treating pancreatic and biliary disease," said Michael P. Phalen, President, Boston Scientific Endoscopy. "Boston Scientific is dedicated to developing technologies and expanding indications that enhance the quality of life for patients, as demonstrated by our new pancreatic indication for the SpyGlass System, as well as the broad range of endoscopic innovations showcased at DDW."
Previously available for use only in the bile and hepatic ducts, Boston Scientific recently received clearance from the Food and Drug Administration to market its SpyScope(R) Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the entire pancreatico-biliary system, including the pancreatic ducts. The SpyScope Catheter is used in conjunction with the SpyGlass Direct Visualization System. The system is intended to guide visualization and accessory devices throughout the pancreatico-biliary system, enabling physicians to diagnose and treat pancreatic cancer or pre-cancerous tissues.
The SpyGlass System is a single-operator system developed to overcome the challenges 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(R) Biopsy Forceps, and deliver therapies such as laser and electrohydraulic lithotripsy (EHL).
Schedule of Key Podium and Poster Presentations (partial listing, all times are Central Time):
All posters are available from 8:00 a.m. - 5:00 p.m. in South Hall of McCormick Place.
Sunday, May 31
This multi-center cumulative study reports on the use of Holmium-YAG laser lithotripsy with SpyGlass cholangioscopy in the management of difficult intraductal biliary stones. Five to ten percent of biliary stones are not amenable to standard endoscopic extraction techniques and while electrohydraulic and laser lithotripsy have been shown to be effective, they have been used sparingly. The study reports that the SpyGlass System now permits for routine use of these technologies. Lead author of the study is Sandeep Patel, M.D.
Tuesday, June 2
This study is designed to evaluate the characteristics of bile duct lesions in patients with primary sclerosing cholangitis (PSC) using the SpyGlass System and compare them to the characteristics of cholangiocarcinoma (CC) found in the literature with the cholangioscopic findings in combination with histologic, cytologic follow-up results. Patients with PSC are at increased risk of developing CC but the absence of symptoms and the lack of reliable diagnostic instruments for early detection of tumors contribute to the poor prognosis in patients. Direct visualization of the biliary system is not yet a standard tool for excluding malignancy in bile duct stenoses, but certain cholangioscopic characteristics of CC have been described. This podium presentation will be given by Alexander Dechene, M.D., Gastroenterology and Hepatology, University Hospital Essen, Essen, Germany, at 8:42-8:54 a.m. in Room S100 of McCormick Place.
This study describes the performance, safety and utility of the SpyGlass System for peroral cholangioscopy and pancreatoscopy in patients at Beth Israel Deaconess Medical Center in Boston. Peroral cholangioscopy and pancreatoscopy allow direct visualization of the bile and pancreatic ducts while being able to take site-directed biopsies and perform electrohydraulic lithotripsy. Lead authors of the study are Ram Chuttani, M.D., and Douglas K. Pleskow, M.D.
A poster presentation reports the results of a prospective 297- patient, 15-center registry that studied the utility and performance of the SpyGlass System for peroral cholangioscopy (POC). The international study was led by Yang K. Chen, M.D.
The SpyGlass Direct Visualization System will be available for demonstration at Boston Scientific's booth #734. The Company will also offer hands-on demonstration sessions in its Simulated Clinical Endoscopy Suites and at its booth stations for the following products: WallFlex(R) Biliary, Esophageal and Enteral Stents, Polyflex(R) Esophageal Stents, Radial Jaw(R) 4 Biopsy Forceps, Resolution(R) Clip, CRE(TM) Balloon Dilators, the RX Biliary System(TM) and the EndoVive(R) Enteral Feeding initial placement and replacement devices. For more information on Boston Scientific's presence at DDW, visit www.bostonscientific.com/ddw2009.
To date there have been more than 50 clinical studies published or presented on the SpyGlass System.
About Digestive Disease Week(R)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 30 - June 4, 2009, at the McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in gastrointestinal research, medicine and technology. For more information, visit www.ddw.org.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
About Boston Scientific Endoscopy
Boston Scientific Endoscopy develops innovative technology for less invasive, more efficient gastrointestinal procedures.
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CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
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