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Avantis Medical Systems, Inc. Announces Study Of New Third Eye® Panoramic™ Device For Colonoscopy At Digestive Disease Week® 2014



5/6/2014 9:13:58 AM

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SUNNYVALE, CA--(Marketwired - May 05, 2014) -

Avantis Medical Systems, Inc., a technology leader in developing novel digital imaging devices, today announced the results of a feasibility study demonstrating that use of the Third Eye® Panoramic™ device with a standard colonoscope was successful and provided enhanced, wide-angle imaging of the colon without adverse events. The results are being presented during the Digestive Disease Week® 2014 (DDW) conference taking place in Chicago from May 3-6 where Avantis will be exhibiting at booth #1028 throughout the conference.

The study (#Mo1517), "Successful Deployment and Use of Third Eye Panoramic, a Novel Side Viewing Video Cap Fitted on a Standard Colonoscope," is being presented in a poster session by Moshe Rubin, MD, Associate Professor of Clinical Medicine, Weill-Cornell Medical College and Director of the Division of Gastroenterology at New York Hospital Queens.

The new study involved 25 patients who were already scheduled to undergo colonoscopy at New York Hospital Queens. For each patient, the Third Eye Panoramic device was attached to the colonoscope at the beginning of the procedure and provided additional views of the left and right sides to complement the forward view of the colonoscope.

"Adding the Third Eye Panoramic cap to existing endoscopy equipment enables enhanced side-viewing imaging of the colon while preserving investments in one's preferred endoscopic platform," said Dr. Rubin. "We tested the device with a Fujifilm EC530-LS Slim Colonoscope® but it is designed to be used with all of the major brands of colonoscopes sold in the U.S."

While colonoscopy is well-recognized as the standard for colorectal cancer detection, there are limitations to the procedure. Research has shown that even when performed carefully by experienced physicians, standard colonoscopy misses about 22-24% of pre-cancerous polyps called adenomas(1-3) and misses about 12% of large adenomas -- measuring at least 1 cm -- which are the ones most likely to transform into cancers.(4-6)

Although there are other reasons why they can be overlooked, two-thirds of the adenomas missed during colonoscopy are located behind the numerous folds in the colon, where they are hidden from the forward view of the colonoscope.(4) Adenomas in "blind spots" behind these folds are easily missed, even with the most meticulous examination.

The new Third Eye Panoramic device is designed to address this challenge and builds on technology that Avantis developed for its previous device, the Third Eye® Retroscope®.

"We listened carefully to endoscopists as they told us what they liked about the previous Retroscope device and what they would like to see improved," said Jack Higgins, MD, Chief Medical Officer for Avantis Medical Systems. "Feedback based on thousands of procedures with the previous device showed that doctors want to see more of the colon by using an additional camera, but they need the product to be easy to use and inexpensive. Not surprisingly, doctors also told us a new device should allow them to continue using their preferred colonoscope."

"We leveraged our expertise to create a solution that addressed all of their feedback. The new Third Eye Panoramic device clips onto the outside of a colonoscope at its tip, leaving the instrument channel completely free for suctioning debris and for passing instruments," said Dr. Higgins. "Also, because the Panoramic device can be disinfected and reused many times, its cost per procedure is very affordable. Last but not least, the new device is 'scope agnostic,' so choice of colonoscope system is left to the doctor."

While the earlier Retroscope device utilized a single additional camera that was aimed backward, the Panoramic device instead has two video cameras that are directed laterally from its left and right sides. Those video images are displayed on both sides of the colonoscope's forward view, and their combined images on a single monitor result in a panoramic view that reveals areas behind folds and flexures (sharp turns) in the colon during both intubation and withdrawal.

"The Third Eye Panoramic device proved to be easy to use, with a very short learning curve," said Dr. Rubin. "It's highly intuitive, and when one of the lateral cameras shows you a polyp behind a fold or flexure, you know exactly which way to deflect the colonoscope to find and remove it. Set up is easy, and it doesn't seem to increase procedure times. We were able to deflect the tip or retroflex the scope without difficulty, and the device didn't interfere with biopsies and polypectomies. Although this was a strictly qualitative feasibility study that was not powered to determine adenoma detection rates, the side views allowed us to see a number of lesions that we wouldn't have been able to find with the colonoscope's forward view alone."

The Third Eye Panoramic device is currently under 510(k) review by the Food and Drug Administration (FDA), and is not available for sale within the United States. Avantis will be demonstrating the device in its booth at DDW, but is not taking orders at this time.

About Digestive Disease Week® (DDW)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract, DDW takes place May 3-6, 2014 at McCormick Place in Chicago. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

About Colorectal Cancer
Colorectal cancer is the second-leading cause of cancer-related deaths in the United States. According to the American Cancer Society, about 150,000 people in the U.S. are diagnosed with colorectal cancer each year and almost 50,000 die from it. Screening and surveillance colonoscopies allow colorectal cancers to be found earlier, when the disease is easier to cure, and cancers can be prevented if adenomas are removed before they become malignant.

About Avantis Medical Systems and the Third Eye Panoramic device
Avantis Medical Systems is focused on delivering cost-effective solutions for improved detection and prevention of cancers of the gastrointestinal tract. The company has an extensive portfolio of patents covering innovative devices based on the convergent technologies of micro-chips and enhanced video processing systems.

Avantis' new product, the Third Eye Panoramic device, utilizes much of the ground-breaking technology that was developed for the Third Eye Retroscope, which was inserted through the instrument channel of a standard colonoscope to provide the physician with a retrograde (backward) view of the lining of the colon. This retrograde view can reveal lesions that are hidden behind folds where they can't be seen with the colonoscope's forward view alone. The Third Eye was shown in clinical studies to help physicians find up to 23-25% more pre-cancerous adenomas than a standard colonoscope alone.

Third Eye Panoramic device features two video cameras that are directed laterally. Combining their images with the one from the colonoscope's forward-viewing camera creates an ultra-wide-angle panoramic view.

The Third Eye Panoramic device is currently under 510(k) review by the Food and Drug Administration (FDA), and is not available for sale within the United States.

(1)Rex DK, Cutler CS, Lemmel GT, et al. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology 1997;112:24-8.
(2)Van Rijn JC, Reitsma JB, Dekker E, et al. Polyp Miss Rate Determined by Tandem Colonoscopy: A Systemic Review. Am J Gastroenterol 2006;101:343-50.
(3)Heresbach D, Barrioz T, Ponchon T, et al. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy 2008;40:284-90.
(4)Pickhardt PJ, Nugent PA, Mysliwiec PA, et al. Location of adenomas missed by optical colonoscopy. Annals of Internal Medicine 2004;141:352-60.
(5)Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc 2011;74:246-52.
(6)Siersema PD, Rastogi A, DeMarco DC, et al. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol 2012;18:3400-8.


Lazar Partners for Avantis Medical Systems, Inc.
Chantal Beaudry
(646) 871-8480 / (917) 494-0227
cbeaudry@lazarpartners.com

Avantis Medical Systems, Inc.
Doug Gielow
(408) 728-5126
dgielow@avantismedical.com



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