FDA grants 510(k) clearance for Avantis’s Third Eye Panoramic device for colonoscopy

20 November 2014 (Last Updated November 22nd, 2018 11:31)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Avantis Medical Systems's Third Eye Panoramic device for colonoscopy.

Third Eye

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Avantis Medical Systems's Third Eye Panoramic device for colonoscopy.

Avantis Medical Systems, which develops digital imaging devices, released the Third Eye Panoramic device using technology made for its product, Third Eye Retroscope.

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.

The Retroscope device had an additional camera aimed backwards, while the Panoramic device has two video cameras, directed laterally from its left and right sides.

Avantis Medical Systems said 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.

The Panoramic device is attached to the tip of the colonoscope at the beginning of the procedure, and can be used during both insertion and withdrawal phases.

Avantis Medical Systems chief medical officer Dr Jack Higgins said: "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.

"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 Panoramic device is designed to help physicians see behind folds in the wall of the colon that can hide pre-cancerous polyps called adenomas."

Dr Sang Kim and Dr Moshe Rubin recently performed a feasibility trial of the Third Eye Panoramic device at New York Hospital Queens Weill Cornell Medical College.

The trial showed the Panoramic device worked well in conjunction with a standard colonoscope and provided improved wide-angle imaging of the colon without adverse events.

Results of the second phase of the trial showed an adenoma detection rate of 48%.

The Panoramic device is designed to be used with any standard adult or pediatric size colonoscope, in order to avoid any substantial capital expense.

It enables physicians to continue using high-quality technologies in which their facilities already invested, including colonoscopes with high-resolution and high-definition video cameras.


Image: Third Eye Panoramic Device. Photo: courtesy of Avantis Medical Systems.