510(k) Clearance for Resposable Third Eye Panoramic Device for Colonoscopy

Avantis Medical Systems, Inc., a technology leader in developing novel digital imaging devices, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Third Eye Panoramic device for use as a resposable product for colonoscopies. Previously cleared as a disposable device, this latest clearance now allows Third Eye Panoramic to be marketed in the U.S. as a resposable device that can be used multiple times prior to disposal.
 
Third Eye Panoramic is a wide-view visualization device designed to provide gastroenterologists (GIs) and other endoscopists a better look at areas of the colon where cancers and pre-cancerous polyps may be hidden from the view of a traditional colonoscope alone, such as behind folds. This is the only optical device on the market that can easily be used in conjunction with any commonly used colonoscope to improve visualization. Physicians can integrate the Third Eye Panoramic within their current practices without the need to invest in expensive infrastructure.
 
“This clearance represents a significant milestone for our organization, as we can now offer the resposable Third Eye Panoramic device to the medical community in the U.S.,” said Anthony DiTonno, CEO of Avantis Medical Systems. “The resposable version of our device provides the same ultra-wide-angle view of the colon as the disposable predicate device, with a much lower cost per procedure. Physicians and facilities will benefit from this innovative technology from both clinical and financial perspectives, and the ultimate winners will be their patients.”
 
The Third Eye Panoramic device contains two video cameras that are directed laterally from its left and right sides. The device is attached to the tip of the colonoscope at the beginning of the procedure, and can be used during both the insertion and withdrawal phases. The Third Eye Panoramic’s lateral images are displayed on each side 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 (sharp turns) in the colon.
 
Based on clinical experience, physicians reported that when using the Third Eye Panoramic they were able to detect pre-cancerous polyps called adenomas in 44 percent of patients.¹
 
“I have used the Third Eye Panoramic in dozens of procedures as part of a feasibility study, and I found that the device is easy to use and doesn’t interfere with the function of the colonoscope,” said Moshe Rubin, MD, director of gastroenterology, New York-Presbyterian/Queens—Weill Cornell Medical College. “This device accomplishes the goal of expanding the view without requiring conversion to a new scope platform or sacrificing the high-definition image quality and superior handling characteristics of standard colonoscopes.”
 
The cleaning and disinfection protocols for this device are similar to the methods used to reprocess colonoscopes between uses.
 
Following this FDA clearance, the company now plans to launch the product as a multi-use device and is currently evaluating strategic partnerships to drive commercial availability.
 
¹ Rubin M, Lurie L, Bose K, Kim S. Expanding the view of a standard colonoscope with the Third Eye Panoramic cap. World J Gastroenterol 2015;21:10683-7.