Results of international, multi-center registry presented at conference
NATICK, Mass., May 16 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that results from an international, multi-center patient registry documenting the safety and clinical utility of the SpyGlass(R) Direct Visualization System will be presented at Digestive Disease Week(R) (DDW), which runs from May 17-22 in San Diego, CA. Registry results will be announced in three separate scientific oral presentations scheduled for Tuesday, May 20. In addition, a total of 15 abstracts on the clinical utility of the SpyGlass System will be presented at the conference, underscoring its widespread acceptance in physician practices.
The SpyGlass patient registry reports on clinical data from 296 patients at 15 U.S. and European medical centers who required peroral cholangioscopy (PO) for the treatment or diagnosis of biliary stones or indeterminate strictures with suspected pathology.
The SpyGlass System is the first single-use direct visualization system that requires only a single physician operator and provides four-way steerability in a four lumen single-use catheter. The catheter provides two dedicated irrigation channels in addition to a 1.2 mm working channel through which diagnostic and therapeutic devices can be used in the biliary ducts. The system includes a miniature 6,000-pixel fiber optic probe attached to a camera that provides physicians with a direct view of a patient's bile ducts, overcoming some of the visual challenges of conventional endoscopic retrograde cholangiography (ERC) procedures.
"We are excited that DDW provides an opportunity to highlight the
safety and therapeutic benefits of the SpyGlass System at the one-year
anniversary of its worldwide launch," said Michael P. Phalen, President,
Boston Scientific Endoscopy. "We have received positive feedback from the
GI community regarding the ability of the SpyGlass System to provide
excellent direct visual access to the bile ducts. We have nearly 300
patients enrolled in our comprehensive patient registry, which enables us
to build further evidence of the clinical utility of cholangioscopy using
the SpyGlass System." Schedule of SpyGlass Patient Registry Presentations:
Tuesday, May 20th (all times are PT)
-- Peroral Cholangioscopy Using a Disposable Steerable Single Operator
Catheter for Biliary Stone Therapy and Assessment of Indeterminate
Strictures - A Multi-Center Experience
Yang K. Chen, M.D., Division of Gastroenterology and Hepatology,
University of Colorado at Denver and Health Sciences Center, and
primary principal investigator of the SpyGlass registry, will present
results that document the performance and utility of PO using the
SpyGlass System over a 12-month period. The presentation will take
place at 4:00 p.m. in Room 1 at the San Diego Convention Center.
-- Peroral Cholangioscopy Guided Stone Therapy - Report of an
International Multi-Center Registry
Mansour Parsi, M.D., Department of Gastroenterology and Hepatology, The
Cleveland Clinic Foundation, and principal investigator in the SpyGlass
registry, will present results on a subset of patients that underwent
PO using the SpyGlass System to determine its effectiveness in the
treatment of difficult-to-remove biliary stones and assess its utility
for the detection of missed stones by ERC. The presentation will take
place at 4:36 p.m. in Room 1 at the San Diego Convention Center.
-- Biopsy of Indeterminate Biliary Strictures - Does Direct Visualization
Kenneth F. Binmoeller, M.D., Interventional Endoscopy Services,
California Pacific Medical Center, San Francisco, CA, and principal
investigator in the SpyGlass registry, will present results on a subset
of patients with indeterminate biliary strictures or filling defects
that underwent ERC followed by PO using the SpyGlass System and the
SpyBite(R) Biopsy Forceps. The lead author of the analysis is Douglas
Pleskow, M.D., Division of Gastroenterology, Beth Israel Deaconess
Medical Center, Boston, MA, and principal investigator in the SpyGlass
registry. The presentation will take place at 5:00 p.m. in Room 1 at
the San Diego Convention Center.
The SpyGlass Direct Visualization System will be available for demonstrations at Boston Scientific's booth #3314. The Company will also offer hands-on demonstration sessions in its Simulated Clinical Endoscopy Suite for the following products: WallFlex(R) Stents, Polyflex(R) Esophageal Stents, Radial Jaw(R) 4 Biopsy Forceps, Resolution(R) Clip, CRE(TM) Balloon Dilators and the RX Biliary System(TM).
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 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://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: http://www.bostonscientific.com.
About Boston Scientific Endoscopy
Boston Scientific Endoscopy develops innovative technology for less invasive, more efficient gastrointestinal procedures. We stand beside our physicians, surgeons and nurses, providing comprehensive support locally and through hands-on education and industry sponsorships, to help improve patient outcomes.
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CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation
|SOURCE Boston Scientific Corporation|
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