The Evolution of the Flexible Endoscope

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Backward. In all 4 directions. In high def. If you haven't looked lately, much has changed about how scopes let your docs see.


If you're in the market for a flexible endoscope, you'll want to know about the latest innovations that will let your doctors visualize more hard-to-see tissues in hard-to-reach places than ever before. They'll be able to see backward during extubation. In all 4 directions. In HD. With enhanced contrast. And they'll have an easier time maneuvering today's slimmed-down scopes.

Are Disposable Scopes the Cure for Cross-Contamination?

In the wake of high-profile reports of pathogens transmitted to patients via flexible endoscopy equipment, the ECRI Institute ranked "cross-contamination from flexible endoscopes" No. 1 on its annual list of the Top 10 Health Technology Hazards in 2010. "Such incidents are almost always associated with failure to follow established cleaning and disinfection/sterilization guidelines, or with the use of damaged or malfunctioning equipment," says ECRI. "The best defense against" this hazard "continues to be careful development of and strict adherence to comprehensive, model-specific reprocessing protocols."

But what if your staff didn't have to reprocess endoscopes? That's the idea behind a newly FDA-approved flexible endoscope from Lumenis. The single-use PolyScope, approved for use in GI and urology procedures, has just 1 reusable element, a fiber optic bundle encased in plastic that's inserted through the disposable catheter's sealed channel, thereby eliminating the potential for patient-to-patient contamination. Invendo Medical's Invendoscope, a disposable flexible endoscope designed specifically for colonoscopy, also could solve the cross-contamination problem; it's currently awaiting FDA approval.

— Irene Tsikitas

Better visualization
Here are 3 visualization-enhancing features your GI docs might be clamoring for:

  • High-definition video. While many physicians prefer HD, until recently there wasn't much research showing a definitive clinical benefit to using HD over standard-definition imaging for endoscopy. In fall 2009, Michael Wallace, MD, professor and director of research for the department of medicine at the Mayo Clinic in Jacksonville, Fla., and colleagues published a study comparing SD and HD colonoscopy that found the latter to be more effective in spotting precancerous polyps. Dr. Wallace says the study is unique in that it wasn't designed as a clinical trial. Researchers retrospectively tracked the rates of polyp detection during the clinic's phased upgrade to HD scopes, with about half of the nearly 2,500 patients getting HD colonoscopy and half getting SD screenings. The rate of adenoma detection was about 29% in the HD rooms vs. 24% in the SD rooms. "That may seem relatively small," says Dr. Wallace, "but if you consider the fact that we do about 14 million colonoscopies a year in the United States, most done for colon cancer prevention, that 5 percentage-point difference adds up to quite a lot." Indeed, it's about 700,000 more detections.
  • Contrast enhancement. This feature filters the light shined on the examination area to increase the contrast between normal and abnormal tissue. The top 3 flexible endoscope manufacturers each have proprietary names for this feature: Fujinon's FICE, Olympus' Narrow Band Imaging (NBI) and Pentax's i-Scan. HD and contrast enhancement aren't mutually exclusive; some endoscope models feature both. For now, however, there is no 5mm HD scope available on the market, since the camera chip needed to achieve HD resolution can't fit in such a small channel. Dr. Wallace says one of the benefits of both technologies is that they let physicians better target tissue for biopsies. He points to a 2008 study that showed high-resolution endoscopy with NBI "detected significantly more patients with dysplasia and higher grades of dysplasia with fewer biopsy samples compared with standard resolution endoscopy."
  • More flexibility. In addition to enhancing image quality, some new flexible endoscopes also promise to help physicians access hard-to-reach areas of the anatomy. For example, Avantis Medical Systems' Third Eye Retroscope lets the physician see backward, behind folds in the lining of the colon, during extubation. And both Boston Scientific's SpyGlass Direct Visualization System and Olympus's new super-slim GIF-XP180N videoscope move in 4 directions, giving physicians better maneuverability and access when examining the bile duct and upper GI tract, respectively.

Ergonomics
Flexible endoscopes that are easier to maneuver through tight strictures of the body require less effort from the physician and cause less pain for the patient, thereby potentially shortening case times and reducing the number of physicians, anesthesia providers and drugs needed to perform procedures. For example, Olympus says its super-slim GIF-XP180N is so small and easy to maneuver that a physician could use the scope to perform a complete EGD exam on a patient using just topical anesthesia and no sedation at all. Similarly, the Invendoscope aims to minimize the need for sedation in colonoscopy by letting the physician maneuver the scope through the colon via remote control, which exerts less pressure on the colon wall than the traditional manual technique. And the SpyGlass system from Boston Scientific is specifically designed to replace traditional endoscopic retrograde cholangiopancreatography (ERCP), which requires 2 physicians, with a single-operator solution.

The Latest in Flexible Endoscopes

Third Eye Retroscope from Avantis Medical Systems This colonoscopy screening tool provides physicians with a backward view to complement the colonoscope's forward view of the lining of the colon. Using a reinforced catheter that fits through the working channel of most standard colonoscopes, the disposable Retroscope delivers a continuous retrograde view of the colon to let you see backward, behind natural folds in the tissue, says the company. Literature documents that up to 12% to 24% of polyps can be missed during examination. The Third Eye has been shown in clinical studies to help physicians find 13.2% more polyps than a colonoscope alone, says the company. $20,000 (video processor), $350 per scope (retroscope catheter), $25 (disposable colonoscope polarizing filter cap), thirdeyeretroscope.com

SpyGlass Direct Visualization System from Boston Scientific Direct visualization of the pancreatico-biliary system with the SpyGlass System offers potential advantages over traditional endoscopic retrograde cholangiopancreatography (ERCP), says the company. Because the system attaches directly to a standard duodenoscope, it eliminates the need for a second physician operator. Combining both capital and consumable components, this single-operator, intraductal system uses a miniature fiber-optic probe that attaches to a camera head and is inserted through a single-use access and delivery catheter. The probe can be steered in 4 directions for an optical view of the bile duct and optically guided biopsies, potentially letting 1 physician diagnose and perform therapeutic intervention in 1 procedure, says the company. spyglassinfo.com

Invendoscopy System from Invendo Medical This single-use, remote-controlled colonoscope features a no-touch/no-push, inverted sleeve technology that lets the physician maneuver the scope more easily through the colon via a handheld remote control. This technique also reduces forces on the colon wall, thereby increasing patient comfort and reducing or potentially eliminating the need for sedation during colonoscopy. Finally, as a single-use device, the scope significantly reduces potential cross-contamination. Although it's not yet approved for use in the United States, Invendo announced last month that it had completed a successful clinical study of the Invendoscope that will serve as the basis for a 510(k) notice submission; the company expects FDA approval sometime in 2010. nvendo-medical.com

PolyScope Disposable Flexible Endoscope from Lumenis Your surgeons can tell their patients that the scope they will use has never been used on any other patient, thanks to this newly FDA-approved, disposable endoscopic system with a reusable fiber optic. Featuring a truly disposable endoscopic catheter system, the PolyScope solves many of the drawbacks of reusable flexible scopes, such as costly and frequent repairs and scope reprocessing problems, says the company. The PolyScope system is easily connected to existing endoscopic towers. With a minimal investment in the reusable 10,000-pixel fiber optic and the disposable catheters, a surgical facility can quickly be up and running with PolyScope, says the company. $650 for disposable catheter, $7,500 for reusable fiber optic, lumenis.com/polyscope

Cellvizio GI from Mauna Kea Technologies Your GI docs can view live, cellular-level images of internal human tissue in real time during endoscopy with this probe-based confocal laser endomicroscopy system. The system consists of confocal miniprobes coupled with a laser scanning unit which, when passed through the endoscope's operating channel, provide physicians with video-rate sequences of tissues at the microscopic level. This advanced imaging technique helps physicians more effectively assess and differentiate normal from abnormal tissue that may be indicative of cancer, potentially letting them treat patients earlier and reduce the number of biopsies needed, says the company. Cellvizio miniprobes for EGD and colonoscopy are compatible with any endoscope with an operating channel of 2.8mm or more. maunakeatech.com

GIF-XP180N from Olympus This super-slim gastrointestinal videoscope, which measures 5.5mm in diameter at the distal end and insertion tube, offers much of the functionality of a larger scope while enhancing insertion capability and patient comfort due to its small size. By letting the physician bend the scope in 4 directions rather than the conventional 2 for super-slim scopes, the GIF-XP180N optimizes maneuverability through the upper GI tract for a more thorough examination and detection of abnormalities. In addition to 4-way angulation, the scope also features Olympus's proprietary Narrow Band Imaging technology, which filters white light to let specific wavelength bands provide a better view of microvessels and subtle changes of the mucosa, says the company. olympusamerica.com

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