Healthcare Industry News:  colorectal cancer screening 

Devices Gastroenterology FDA

 News Release - May 3, 2007

Avantis Medical Systems Announces FDA 510(k) Approval for the Third Eye Retroscope

SUNNYVALE, Calif., May 3 (HSMN NewsFeed) -- Today Avantis Medical Systems, Inc. announced that it has received FDA clearance to market its Third Eye(TM) Retroscope(TM) Auxiliary Endoscopy System.

The Third Eye Retroscope is an imaging device that is used during colonoscopy to provide an additional view that can reveal polyps, cancers and other lesions that might be missed during a standard colonoscopy procedure.

Although colonoscopy is widely regarded as the "gold standard" for detection of abnormalities in the colon, research has shown that a significant number of polyps and cancers may be missed during colonoscopy. (1,2) In about 2/3 of cases where abnormalities are missed, it is because they lie behind flexures (tight turns) or behind folds in the colon wall that hide them from the forward-viewing colonoscope.(3)

Developed by Avantis Medical Systems, Inc. of Sunnyvale, Calif., the Third Eye Retroscope is passed through the instrument channel of a standard colonoscope until it extends beyond its tip. As it emerges, the device automatically turns around 180 degrees to aim back toward the tip of the colonoscope. Then, as the colonoscope is withdrawn, the Third Eye follows along to provide a continuous retrograde view of the colon. This retrograde view complements the forward view of the colonoscope and may reveal abnormalities that are hidden behind folds and flexures.

A laboratory bench study(4) found that the device dramatically improved the ability of endoscopists to detect simulated polyps in anatomical models, and a pilot study demonstrated the feasibility of the device for use in humans.(5) A larger clinical study to evaluate efficacy is currently in progress.

According to David Watts, MD, a co-founder of the company and member of the Avantis Scientific Advisory Board, "This is the most exciting new development for colorectal cancer screening in a decade."

Fred Seddiqui, Avantis' CEO, said, "We are delighted to have received FDA approval under the 510(k) process. It is a great step forward for the Third Eye Retroscope. There is growing recognition of the need for new technology to improve the detection rate during colonoscopy, and we believe the Third Eye offers the ideal solution."

"This cutting-edge technology is complementary to the existing infrastructure," said Dr. Watts. "Because the Third Eye works in conjunction with a standard colonoscope, it simply takes the best existing technology and makes it even better. That means facilities don't need to make major capital outlays to replace existing equipment, and endoscopists have to make only minor adjustments to the techniques that they've used successfully for years."

About Avantis

Avantis Medical Systems, Inc. is a medical device company founded to develop and manufacture catheter-based endoscopic devices. Based in Sunnyvale, Calif., the Company's initial focus is on devices for use in detecting and treating cancers and other abnormalities of the gastrointestinal (GI) tract.

The Avantis team has many decades of experience in the medical device industry, and focuses on developing solutions for problems, hazards and inconveniences associated with traditional technologies. The Company is developing a number of innovative devices based on the convergent technologies of micro-chips and reinforced catheters.

(1) Rex DK, Cutler CS, Lemmel GT, Rahmani EY. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology 1997;112:24-28.

(2) Pabby A, Schoen RE, Weissfeld JL, Burt R. Analysis of colorectal cancer occurrence during surveillance colonoscopy in the dietary Polyp Prevention Trial. Gastrointestinal Endoscopy 2005;61:385-391.

(3) Pickhardt PJ, Nugent PA, Mysliwiec PA, Choi JR. Location of adenomas missed by optical colonoscopy. Annals of Internal Medicine 2004;141:352-360.

(4) Triadafilopoulos G, Watts D, Higgins J, Van Dam J. A novel retrograde-viewing auxiliary imaging device ("Third Eye Retroscope(TM)") improves the detection of simulated polyps in anatomical models of the colon. Gastrointestinal Endoscopy 2007;65:139-44.

(5) Triadafilopoulos G, Li J, Watts D, Higgins J, Van Dam J. First Human Use Evaluation of the Third Eye Retroscope Auxiliary Imaging System. Gastrointestinal Endoscopy 2007;65:AB333.


Source: Avantis Medical Systems

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