Boston Scientific launches Spyglass bile duct examination system
4 June 2007 Natick, Mass., USA. Boston Scientific Corporation
(NYSE:BSX) has announced the worldwide availability of SpyGlass, a
single-operator system for visual examination of the bile ducts.
SpyGlass is a direct visualization system for single-operator
duodenoscope assisted cholangiopancreatoscopy (SODAC). It provides
unprecedented, direct visualization of all bile-duct quadrants. It has
four-way steerability and dedicated irrigation channels in addition to a 1.2
mm working channel through which diagnostic and therapeutic devices can be
used. Overcoming limitations Direct visualization of the biliary
system (cholangioscopy) has been possible for more than 30 years and its
benefits are well documented in numerous published studies. However, the
technology has not been widely adopted due to the cost and limitations of
available devices. Boston Scientific designed the SpyGlass System to help
gastrointestinal (GI) endoscopists overcome these hurdles and to make
cholangioscopy feasible for a larger number of physicians. Direct
visualization with the new system potentially offers significant procedural
and clinical advantages over conventional Endoscopic Retrograde
Cholangiopancreatography (ERCP).
How ERCP is used ERCP is used to diagnose and treat challenging
conditions of the bile ducts and pancreas, such as removing gallstones,
opening obstructed bile ducts and obtaining biopsies in suspected tumours.
With conventional ERCP, physicians use an endoscope to view the entrance
to the biliary tract while access to the ducts is gained with small
catheters passed through the scope's working channel. Visualization is
achieved by injecting contrast media and taking x-rays of the treatment
area. However, the resulting flat, two-dimensional, black and white images
often do not provide sufficient information to obtain a complete diagnosis.
Estimates indicate that at least 30% of ERCPs performed using brush cytology
or biopsy forceps for tissue acquisition result in the need for additional
testing. If ERCP is insufficient to make an adequate diagnosis, or
therapeutic intervention requires direct visualization into the bile ducts,
the physician may choose to perform cholangiopancreatoscopy. Historically,
this procedure has required two endoscopists, one to operate the therapeutic
duodenoscope (mother scope) and a second to steer the cholangioscope (baby
scope) and to operate its working channel. Conventional
cholangiopancreatoscopy has failed to gain widespread adoption as a solution
because available systems are labour intensive, and include instrumentation
that is commonly viewed as fragile and difficult to manipulate.
Advantages of the new system The SpyGlass System overcomes the
shortcomings of both conventional ERCP and currently available peroral
cholangiopancreatoscopy systems, enabling a single physician to potentially
secure a definitive diagnosis and perform therapeutic intervention in one
procedure.
The SpyGlass System utilizes a miniature 6,000-pixel fibre-optic probe
that attaches to a camera head. The probe is inserted through a single-use
access and delivery catheter that can be steered in four directions to
access and inspect the treatment area. The System attaches directly to a
standard duodenoscope, eliminating the need for a second physician operator.
"Given that nearly half a million ERCP procedures are performed in the US
each year, Boston Scientific is committed to developing a product that can
overcome technical issues, and facilitate the widespread adoption of direct
visualization technology," said Michael Phalen, President of Boston
Scientific's Endoscopy division.
"We worked closely with leading gastroenterologists to develop the
SpyGlass System and provide an enhanced visual method to perform ERCP. We
are delighted to formally make the SpyGlass System available to the GI
community and help improve the quality of health care to patients."
Boston Scientific is also establishing a comprehensive patient registry to
build further evidence of the clinical utility of the SpyGlass System.
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