Multi-Center Patient Registry Supports Safety and Clinical Utility of Boston Scientific's...

Multi-Center Patient Registry Supports Safety and Clinical Utility of Boston
Scientific's SpyGlass(R) Direct Visualization System
Positive results presented at Digestive Disease Week(R) 2008

NATICK, Mass. and SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- Boston
Scientific Corporation (NYSE: BSX) today announced results from an
international, multi-center patient registry documenting favorable safety and
clinical utility data for its SpyGlass(R) Direct Visualization System, which
offers extensive visual access to the biliary tract. Results from the
registry were presented by Yang K. Chen, M.D., Division of Gastroenterology &
Hepatology, University of Colorado at Denver and Health Services Center and
lead investigator, at Digestive Disease Week(R) (DDW) in San Diego. Two
additional subset analyses from the SpyGlass patient registry were also
presented at the conference.
The patient registry reports on clinical data from 296 patients at 15
medical centers (10 U.S. and 5 European sites) who required peroral
cholangioscopy (PO) for stone therapy or investigation of suspected pathology
with or without biopsy. Results of the study indicate that PO using the
SpyGlass System can be safely performed by a single operator and provides
reliable access to target sites for visual inspection and stone therapy. In
addition, the SpyBite(R) Biopsy Forceps were found to obtain adequate
histologic tissue specimens.
"The SpyGlass registry provides important information to physicians in
assessing the safety and clinical effectiveness of the system," said Dr. Chen.
"Preliminary results demonstrate that visual examination combined with
directed tissue sampling using the SpyGlass System may improve accuracy of
diagnosis in patients with indeterminate bile duct lesions."
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 procedures (ERCP).
As part of the international multi-center SpyGlass registry, Mansour
Parsi, M.D., Department of Gastroenterology and Hepatology at the Cleveland
Clinic, also reported on clinical data from 98 patients, demonstrating that
peroral cholangioscopy using the SpyGlass System is safe and effective for the
treatment of difficult-to-remove biliary stones. In addition, Dr. Parsi
concluded that the rate of missed stones by an ERCP may be higher than
previously reported and more research is required.
An additional subset analysis from the patient registry, led by Douglas
Pleskow, M.D., Director, Colon Cancer Center and Co-Director, GI Endoscopy at
Beth Israel Deaconess Medical Center in Boston, involved 136 patients with
indeterminate biliary strictures or filling defects who underwent an ERCP
followed by peroral cholangioscopy using the SpyGlass System and the SpyBite
Biopsy Forceps. The study results indicate that targeted biopsies using the
SpyGlass System are feasible and safe, and provide specimens adequate for
histology in 89 percent of cases. Preliminary results also show that biliary
biopsies obtained under direct visualization by peroral cholangioscopy using
the SpyBite Biopsy Forceps can be useful in selected clinical situations
including histologic confirmation of malignant or benign intrinsic lesions of
the bile duct. Patient follow-up for this registry is ongoing.
"This multi-center registry adds to the growing body of evidence that
supports the benefits of the SpyGlass System for single-operator
duodenoscope-assisted cholangiopancreatoscopy in performing diagnostic and
therapeutic endoscopic procedures such as targeted biopsies and the management
of biliary stones," said Michael P. Phalen, President, Boston Scientific
Endoscopy. "The SpyGlass System is making cholangioscopy feasible for
physicians worldwide and improving the quality of healthcare for patients."
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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of Section 21E of the Securities Exchange Act of 1934. Forward-looking
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include, among other things, statements regarding clinical trials, regulatory
approvals, competitive offerings, product performance and our market position.
If our underlying assumptions turn out to be incorrect, or if certain risks or
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affect our future operations, see Part I, Item 1A - Risk Factors in our most
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contained in the forward-looking statements. This cautionary statement is
applicable to all forward-looking statements contained in this document.

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

SOURCE Boston Scientific Corporation

Media, Paul Donovan, +1-508-650-8541 (office), +1-508-667-5165 (mobile), or
Investors, Larry Neumann, +1-508-650-8696 (office), both of Boston Scientific
Corporation