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news.Avantis Medical Systems, a developer of novel chip-on-catheter digital imaging devices, has received a new 510(k) clearance for its Third Eye Retroscope, supporting the claim for increased detection of cancerous and precancerous polyps in the colon.
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According to the company, 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.
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.
Scott Dodson, president and CEO of Avantis Medical, said: The 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. We are excited about the demonstrated capability of our device and its potential for saving lives.
The Third Eye Retroscope passes through the working channel of the standard colonoscope till it extends beyond its distal tip. As it emerges, the device automatically turns around 180 degrees to aim back toward the tip of the colonoscope and the endoscopist locks it into place.
As the colonoscope is withdrawn from the colon, the Third Eye comes along with it, providing a continuous retrograde view to complement the forward view of the colonoscope. When a lesion has been detected in the retrograde view, quick and easy removal of the Third Eye Retroscope frees up the working channel for polypectomy snare or biopsy forcep.