Surgery, general care

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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