Diagnostics & Imaging Week

Avantis Medical Systems (Sunnyvale, California) is getting a better view when it comes down to properly finding tumors during colonoscopies. And the company literally means that.

The company reported this week that it has received 510(k) clearance from the FDA for its Third Eye Restroscope, a chip-on catheter device. Avantis said it is in a limited market release of the device.

The device literally is the "third eye" when it comes to performing colonoscopies, said Scott Dodson, CEO of Avantis.

"One eye is the physician's eye, another is the colonscope's eye and the third and final eye is the third eye," he told Diagnostics & Imaging Week.

The Third Eye Retroscope is indicated for use with colonoscopy to provide the physician with an additional view of the colon for diagnostic and detection purposes.

Shaped like a J, the device is passed through the instrument channel of a standard colonoscope until it extends beyond its tip. As it emerges, the device automatically turns 180 degrees to aim "backward" toward the tip of the colonoscope. Then, as the colonoscope is withdrawn from the colon, the device provides a continuous retrograde view to reveal polyps, cancers and other lesions that might be hidden from the view of a standard colonoscope.

"It operates as a rear-view mirror for the physician," Dodson told D&IW.

The device includes:

An integrated light source on the catheter provides illumination without the need for a costly additional external light source.

Retrograde view that reveals areas behind folds in the colon wall.

A foot pedal that captures still images from both the forward and retrograde views simultaneously.

A video processor and monitor integrate with standard colonoscopy systems and display both forward and retrograde views on the same monitor.

To date the device has been used in clinical trial settings and is being prepped to hit the market.

"Our national study indicated that the Third Eye Retroscope, when used in combination with a standard forward-viewing colonoscope, revealed areas that are often hidden from the standard colonoscope," said Douglas Rex, MD, Third Eye investigator, at Indiana University School of Medicine and director of endoscopy at Indiana University Hospital (both Indianapolis). "The device also enabled detection of 13% more polyps and 10.9%more adenomas than the colonoscope alone. These results are important to doctors and patients because most cases of colon cancer arise from adenomas."

Colorectal cancer is the second-leading cause of cancer death in the U.S. and Europe. Most of these cancers can be treated if hif they are detected early and even more cases can be prevented if pre-cancerous polyps are removed before they become malignant. However research has shown that 12% to 24% of polyps and a significant number of cancers can be missed during colonscopies.

Even more revealing is a recent large study analysis involving more than 10,000 cancer patients who died of colorectal cancer that indicated that colonoscopy missed about one-third of colorectal cancers on the left side of the colon and 40% to 67% of the colorectal cancers on the right side of the colon. The company said that the study showed that twice the number of patients had polyps on the right-side of the colon vs. the left side.

"Unlike most market development technologies, there isn't a need to prove the need for the device, there is well-documented evidence that shows us there is a clear need for the device," Rex said. "The miss rates for a colonoscopy is incredible. This remains one of the most hotly contested topics for gastrointestinal specialists (GI)."

One could argue the point that this was not only a serious matter for GIs but also for venture capitalists and financers. Even in a tough economy, financiers continued to support Avantis and its vision and the company was able to close on $10 million in Series C founding to facilitate the launch of the Third Eye in January. The company raised $12 million in its Series B round of financing in October 2006.

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