Avantis Medical Systems Announces FDA 510(k) Clearance for the Third Eye(R) Retroscope(R) for Improved Polyp Detection in... ( SUNNYVALE Calif. Feb. 17 /- Avantis M...)

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Avantis Medical Systems Announces FDA 510(k) Clearance for the Third Eye(R) Retroscope(R) for Improved Polyp Detection in the Colon

Date:2/17/2009

SUNNYVALE, Calif., Feb. 17 /PRNewswire/ -- Avantis Medical Systems, Inc., a technology leader in developing novel chip-on-catheter digital imaging devices, announced today that it has received a new 510(k) clearance for its Third Eye(R) Retroscope(R) (Third Eye), supporting the claim for increased detection of cancerous and pre-cancerous polyps in the colon. This is the first technology that has been cleared by the FDA to enhance polyp detection when used in conjunction with the gold standard in colonoscopy.

"FDA clearance of our new 510(k) is important to physicians and patients alike because it acknowledges the value of the Third Eye in providing physicians an additional view of the colon, which enables them to detect more polyps than colonoscopy alone," said Scott Dodson, President & CEO of Avantis Medical. "We are excited about the demonstrated capability of our device and its potential for saving lives."

Colorectal cancer is the second leading cause of cancer death in the US and Europe.(1) However, most cancers of the lower gastrointestinal (GI) tract can be successfully treated if detected early. Even more cases can be prevented if pre-cancerous polyps are removed before they become malignant. Every year tens of millions of people have a colonoscopy to screen for colorectal cancer.

Colonoscopy is widely regarded as the "gold standard" for detection of abnormalities in the colon. However, research has revealed that 12-24 percent of polyps and a significant number of cancers can be missed during colonoscopy.(2,3,4)

Furthermore, a recent large study analysis involving more than 10,000 cancer patients who died of colorectal cancer indicated that colonoscopy missed about one-third of colorectal cancers (CRCs) on the left side of the colon and 40-67 percent of the CRCs on the right side of the colon.(5) The authors stated that, of the study patients who later passed away from CRC
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Avantis Medical Systems Announces FDA 510(k) Clearance for the Third Eye(R) Retroscope(R) for Improved Polyp Detection in...( SUNNYVALE Calif. Feb. 17 /- Avantis M...)