When it comes to diagnosing and treating digestive diseases, visualization is key — a fact that evidentially has not gone unnoticed by the 280-some med-tech developers in their exhibit booths at this week's Digestive Disease Week (DDW) meeting in Washington D.C.

DDW — considered the largest international gathering of professionals in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery — kicked off Saturday and runs through Thursday at the Washington Convention Center.

A glance at just some of the new technologies being launched at the DDS event suggests that finding new ways to help physicians see more clearly into the digestive tract is at the top of the agenda for many companies in this sector.

Among those competing for the attention of DDW attendees is Boston Scientific (Natick, Massachusetts), which just reported worldwide commercial availability of its SpyGlass Direct Visualization System for single-operator duodenoscope-assisted cholangiopancreatoscopy (SODAC) — that lengthy description boiling down to mean visual examination of the bile ducts.

According to Boston Scientific, the SpyGlass System requires only one physician operator, providing unprecedented, direct visualization of all bile-duct quadrants. SpyGlass is designed to provide 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.

The SpyGlass Direct Visualization System will be demonstrated at booth 2401 at DDW.

"The primary benefit is that one physician can do this," Len Farris, a global marketing director for Boston Scientific, told Medical Device Daily.

Farris said the SpyGlass system provides the opportunity for a more definitive diagnosis of digestive diseases, which leads to earlier treatment.

Direct visualization of the biliary system (via cholangioscopy) has been possible for more than 30 years and its benefits are well documented in numerous published studies, the company says. However, it says that the technology has not been widely adopted due to the cost and limitations of available devices.

Boston Scientific said it designed the SpyGlass System to help GI endoscopists overcome these hurdles and to make cholangioscopy feasible for a larger number of physicians. Direct visualization with the SpyGlass System potentially offers significant procedural and clinical advantages over conventional Endoscopic Retrograde Cholangiopancreatography (ERCP), according to the company.

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 tumors. 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, 2D, black and white images often do not provide sufficient information to obtain a complete diagnosis, according to Boston Scientific. 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, the company said.

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 another to steer the cholangioscope (or baby scope) and to operate its working channel. Thus, conventional cholangiopancreatoscopy has failed to gain widespread adoption as a solution because available systems are labor-intensive, and include instrumentation commonly viewed as fragile and difficult to manipulate.

SpyGlass, Boston Scientific says, 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 uses a miniature 6,000-pixel fiber-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 the size of the DDW conference, Farris told MDD that "it's terrific timing" to be able to introduce the company's SpyGlass system this week.

DDW is jointly sponsored by the American Association for the Study of Liver Diseases (Alexandria, Virginia), the American Gastroenterological Association (Bethesda, Maryland), the American Society for Gastrointestinal Endoscopy (Oak Brook, Illinois) and the Society for Surgery of the Alimentary Tract (Beverly, Massachusetts).

Another company promoting advanced GI visualization is Given Imaging (Yoqneam, Israel), which said that data from 88 posters and 79 oral presentations on its PillCam capsule endoscopy will be presented at the conference. The company also will host a number of events throughout the week at booth 2419.

The company also just reported receiving FDA clearance for its PillCam SB 2 video capsule and RAPID 5 Software (see Product Briefs, p. 9.)

Also at DDW this week:

• Mauna Kea Technologies (MKT; Paris), a developer in the field of in vivo cellular imaging for biomedical research and clinical practice, said that five oral presentations and eight posters on MKT's Cellvizio-GI will be presented at the conference.

Cellvizio-GI is the company's technology platform for gastrointestinal applications designed to enable real-time viewing of tissues at the microscopic level. Cleared by the FDA in September 2005, the company said Cellvizio-GI is the first and only confocal endo-microscopy instrument compatible with all endoscopes and allowing real-time imaging of the mucosa at 12 frames per second.

• Mereteck Diagnostics (Lafayette, Colorado) is exhibiting its BreathTek UBT (urea breath test) kit at its DDW booth 3351.

According to the company, BreathTek UBT is the only breath test available that is FDA cleared to test for both initial diagnosis and post-treatment monitoring of H. pylori infection in adults, an important pathogen in the upper GI tract of humans. BreathTek UBT is 95% sensitive and specific, and is also used to confirm eradication four weeks following completion of treatment.