The FDA has issued 510(k) clearance to a novel dual-camera imaging device designed to help colonoscopists detect polyps behind folds in the wall of the colon, according to a company press release.
The Third Eye Panoramic device (Avantis Medical Systems) uses technology developed for its single-camera predecessor, the Third Eye Retroscope, but “instead has two video cameras that are directed laterally from its left and right sides,” the release said. By displaying images on both sides of the colonoscope’s forward image, a panoramic, ultra-wide-angle view exceeds 300 degrees and areas behind the colon’s folds and flexures are now visible.
“We spent thousands of hours observing endoscopists as they performed colonoscopies using the Third Eye Retroscope, and we listened to their concerns regarding the ease of use,” Jack Higgins, MD, chief medical officer for Avantis, said in the release. “They liked the fact that additional cameras allowed them to see more of the colon, and they asked us to find a way to do that more easily and inexpensively, and without occupying the channels of their colonoscopes.”
The device attaches to the tip of the colonoscope, leaving the channel free unlike its predecessor, and can be used during insertion and withdrawal phases, according to the release. It can be used with any standard adult or pediatric sized colonoscope, thus reducing costs.
Data from a feasibility study of the device performed at New York Hospital Queen Weill Cornell Medical College by Sang Kim, MD, and Moshe Rubin, MD, were recently presented at the American College of Gastroenterology Annual Scientific Meeting. The results indicated that the device worked well with a standard colonoscope, safely provided enhanced imaging and enabled a 48% adenoma detection rate.
“Improving the quality of colonoscopy with enhanced imaging has been shown in recent studies to increase our ability to detect precancerous polyps,” Rubin said in the release. “Gastroenterologists can continue to utilize their existing high definition standard colonoscopies without new investments in capital equipment. Additionally, the non-obtrusive video cap does not change the dynamics of scope insertion of maneuverability, thus providing an enhanced nearly 360-degree view without sacrificing scope familiarity, usability or efficiency.”
The company awaits feedback on the device from leaders in the field, and will develop a resposable version of the device, Doug Gielow, vice president of sales and marketing for Avantis, said in the release.