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New Journal Article Highlights Value of Third Eye(R) Retroscope(R) Device for Patients Undergoing Surveillance or Diagnostic Colonoscopies


July 10, 2012 - SUNNYVALE, CA

Avantis Medical Systems today announced publication of an article in the World Journal of Gastroenterology showing that Third Eye® colonoscopy significantly improves adenoma detection rates in patients undergoing surveillance or diagnostic colonoscopies.(1)

The study, "Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup," was a post-hoc analysis of data collected in the Third Eye Retroscope Randomized Clinical Evaluation (TERRACE) -- a prospective, randomized, controlled trial involving patients scheduled for colonoscopy for screening, surveillance or diagnostic workup.(2) The aim of this new analysis was to determine whether certain subsets of the patient population would benefit more than others from use of the Third Eye device during colonoscopy. http://www.wjgnet.com/1007-9327/pdf/v18/i26/3400.pdf

The results showed that the most significant difference was related to the "indication" for the procedure -- i.e., the reason why the patient was having a colonoscopy. In patients undergoing surveillance for a history of previous adenomas, Third Eye colonoscopy detected 35.7% additional adenomas compared to standard colonoscopy. In patients undergoing diagnostic workup because of symptoms, Third Eye colonoscopy detected 55.4% additional adenomas. The combined results for those two groups with above-average risk for colorectal cancer showed a highly significant 40.7% advantage for Third Eye colonoscopy compared to standard colonoscopy.(1)

The Third Eye Retroscope device is an FDA-cleared, disposable, catheter-based camera that provides physicians with a backward view to complement a colonoscope's forward view of the lining of the colon during colonoscopy.

"We found that use of the Third Eye Retroscope device improves the quality of colonoscopy to an extent that currently cannot be matched by any other technique or technology," said Peter D. Siersema, MD, PhD, Director of the Department of Gastroenterology and Hepatology at University Medical Center Utrecht in The Netherlands and Principal Investigator for the TERRACE Study. "All patients benefit when additional pre-cancerous adenomas are found and removed during colonoscopy, but our results showed that patients who have higher risk for developing colorectal cancer can gain even more benefit from this new technology than patients who are having routine screening colonoscopy."

While colonoscopy is generally regarded to be the best available method for finding and removing adenomas and early cancers, up to 21-24% of adenomas are missed.(3,4) Perhaps most importantly, even when performed by experts using their best technique, colonoscopy misses about 12% of large adenomas -- those measuring at least 1 cm in diameter -- which have the greatest likelihood of transforming into cancers.(1,5,6)

Although there are many other reasons why they can be overlooked, 2/3 of missed adenomas are located behind folds where they are hidden from the forward-viewing colonoscope.(6) Use of the retrograde (or backward) viewing Third Eye device allows physicians to see those hidden areas in the colon.

"A recent study in the New England Journal of Medicine(7) showed that removal of adenomas through colonoscopy results in a 53% reduction in deaths from colorectal cancer," said Jack Higgins, MD, Chief Medical Officer at Avantis Medical Systems. "We believe that we can decrease the mortality rate even more if we can find and remove more of the large, truly pre-cancerous adenomas. This new analysis of TERRACE data confirms the results of previous research by others showing that standard colonoscopy misses 12% of those large adenomas. However, no large adenomas were missed during Third Eye colonoscopy."

According to Rick Randall, Chairman and Chief Executive Officer at Avantis Medical Systems, "Our market research indicates that patients at higher risk for colon cancer are much more compliant in managing their health through surveillance colonoscopy and adenoma removal. We believe this newly published clinical evidence will heighten patients' awareness of, and demand for, Third Eye colonoscopy."

About Colorectal Cancer
colorectal cancer is the second-leading cause of cancer-related deaths in the United States, and according to the American Cancer Society, about 150,000 people in the U.S. are diagnosed with colorectal cancer each year.(8) Screening and surveillance 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.(8)

About the Third Eye Retroscope and Avantis Medical Systems, Inc.
Avantis Medical Systems, Inc., a technology leader in developing novel catheter-mounted digital imaging devices, markets the Third Eye Retroscope, an FDA-cleared, disposable, catheter-based camera indicated for use with a standard colonoscope to provide an additional view of the colon for diagnostic purposes. It is inserted through the instrument channel of a standard colonoscope to provide the physician with a retrograde (backward) view of the lining of the colon simultaneously with the forward view of a standard colonoscope. This retrograde view allows physicians to see more of the colon and can reveal lesions that are hidden behind folds. Clinical evidence shows that two-thirds of adenomas missed during colonoscopy are located behind these folds in the wall of the colon, where they are often unseen in the forward view of the colonoscope, even during the most meticulous examinations.

The Third Eye Retroscope device is commercially available in the United States and is reimbursed by Medicare.

For more information, visit www.Avantis.ThirdEyeColonoscopy.com.

(1) 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.

(2) Leufkens AM, DeMarco DC, Siersema PD, et al. Effect of a Retrograde-Viewing Device on Adenoma Detection Rate during Colonoscopy: The "TERRACE" Study. Gastrointest Endosc 2011;73:480-9.

(3) Rex DK, Cutler CS, Mark DG, et al. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology 1997;112:24-8.

(4) 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.

(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) Pickhardt PJ, Nugent PA, Schindler WR, et al. Location of adenomas missed by optical colonoscopy. Ann Intern Med 2004;141:352-9.

(7) Zauber AG, Winawer SJ, Waye JD, et al. Colonoscopic Polypectomy and Long-Term Prevention of Colorectal-Cancer Deaths. N Engl J Med 2012;366:687-96.

(8) American Cancer Society. Importance of colorectal cancer screening www.cancer.org/Cancer/ColonandRectumCancer/MoreInformation/ColonandRectumCancerEarlyDetection/colorectal-cancer-early-detection-importance-of-crc-screening

Media Contacts:
Doug Gielow
+1 (408) 636-7263
dgielow@avantismedical.com

Chantal Beaudry
Fern Lazar
+1 (212) 867-1762
cbeaudry@lazarpartners.com
flazar@lazarpartners.com

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