Digital Imaging device specialist Avantis Medical Systems tells us it has gained U.S. FDA 510(k) clearance of its of Third Eye® Panoramic™ Device for Colonoscopy
Background
Colonoscopy is the “gold standard” for detecting cancers and pre-cancerous adenomas in the colon. However, extensive research has shown that even when performed carefully by experienced physicians, standard colonoscopy misses approximately 24% of adenomas of all sizes. Even more importantly, standard colonoscopy misses 12% of large adenomas – measuring at least 1 cm in diameter – which are the ones most likely to progress to colon cancer. A number of factors have been shown to affect adenoma detection rates, including adequacy of bowel preparation and the amount of time spent examining the lining of the colon. However, approximately 2/3 of adenomas that are missed are located behind the numerous folds in the colon, where they are hidden from the forward view of the colonoscope. Adenomas and other abnormalities in those “blind spots” behind folds are easily missed with a standard colonoscope.
The Third Eye Panoramic device utilizes technology that was developed for the company’s earlier product, the Third Eye® Retroscope®. Like its predecessor, the Panoramic device is designed to help physicians see behind folds in the wall of the colon that can hide pre-cancerous polyps called adenomas, but with improved ease-of-use and reduced expense.
While the Retroscope device had one additional camera that was aimed backward, the new Panoramic device instead has two video cameras that are directed laterally from its left and right sides. The video monitor displays the lateral images on both sides of the colonoscope’s forward image, resulting in an ultra-wide-angle view of more than 300 degrees. This “panoramic” view reveals areas behind folds and flexures in the colon.
The Third Eye Panoramic device is attached to the tip of any standard adult or pediatric size colonoscope so avoids any substantial capital expense and it allows physicians to continue using the high-quality technologies in which their facilities have already invested, generally including colonoscopes with high-resolution or even high-definition video cameras. It is attached at the beginning of the procedure, and can be used during both the insertion and withdrawal phases. Because it clips onto the outside of the colonoscope, it leaves the channel completely free, in contrast to the earlier device that occupied the channel of the colonoscope and had to be removed when the physician inserted instruments to remove polyps.
Investigator comments
Dr. Sang Kim and Dr. Moshe Rubin recently performed a feasibility study of the Third Eye Panoramic device at New York Hospital Queens Weill Cornell Medical College. They found that the Panoramic device worked well in conjunction with a standard colonoscope and provided enhanced, wide-angle imaging of the colon without adverse events.
“Because our study involved the first use of this device in humans, we didn’t perform tandem procedures to compare use of the Third Eye Panoramic device with routine colonoscopy. Instead, we were focused on the feasibility of using the device along with a standard colonoscope,” said Dr. Rubin. “However, we found that the side views from the Panoramic device were helpful for seeing areas behind folds, and the overall adenoma detection rate when using the device was 48%. As for the feasibility of the device, I was able to complete all procedures with no restrictions or changes in terms of how I always perform colonoscopy, except that I benefited from the additional side views. The adjustment to using the Third Eye Panoramic device came naturally to me because it attaches to any standard colonoscope, so I was able to use the scope I prefer. I expect this to be a great advantage in terms of physician adoption.”
Company comments
“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,” said Jack Higgins, MD, Chief Medical Officer for Avantis Medical Systems. “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.”
“Now that the Third Eye Panoramic device has been cleared by the FDA for marketing, it will allow other leaders in the field of gastroenterology to provide us with feedback as we develop a resposable version of the device,” said Doug Gielow, Avantis’ Vice President for Sales & Marketing. “At the same time we can finalize our selection of a partner with broad domestic and international commercial distribution that is beyond the reach of a development company.”
Source: Avantis Medical Systems, Inc.
