Press Release Source: Avantis Medical Systems On Tuesday October 19, 2010, 4:32 pm EDT

SAN ANTONIO, TX–(Marketwire – 10/19/10) – Avantis Medical Systems, Inc., a technology leader in developing novel catheter-mounted digital imaging devices, today announced three new publications validating the use of the Third Eye® Retroscope® during colonoscopy procedures for increased detection of adenomas and other polyps. The data were presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course taking place in San Antonio, TX, from October 15 through October 20, 2010. Avantis Medical is exhibiting at booth #1220.

Peter D. Siersema, MD, PhD of University Medical Center Utrecht, Utrecht, The Netherlands, Principal Investigator, led the podium presentation titled, “A Retrograde-Viewing Auxiliary Imaging Device (Third Eye Retroscope) Improves Adenoma Detection Rates (ADR) During Colonoscopy” (19).

The Third Eye Retroscope Randomized Clinical Evaluation (the “TERRACE” Study) was a prospective, multicenter, randomized, controlled clinical trial conducted by 21 investigators at nine centers in the United States and Europe. In the study, 372 patients underwent two complete same-day, tandem exams using a standard colonoscope with and without the Third Eye Retroscope. The researchers concluded that the Third Eye Retroscope, in combination with a colonoscope, significantly increased detection rates for pre-cancerous adenomas by providing an additional retrograde view of the colon.

“In a head-to-head comparison of Third Eye colonoscopy and standard colonoscopy, we were able to determine that the Third Eye Retroscope increases adenoma detection rates by a significant 23.2 percent,” said Dr. Siersema. “Incorporating the Third Eye Retroscope into colonoscopic exams can provide a powerful advantage for physicians and their patients in the fight against colorectal cancer.”

Highlights of the TERRACE Study include:

• Patients were randomized into two groups: patients in group A underwent a standard colonoscopy followed by a Third Eye colonoscopy while patients in group B first underwent a Third Eye colonoscopy followed by a standard colonoscopy.
• Interest was focused on the number of additional pre-cancerous adenomas detected during the second procedures in each group.
• Previous tandem-designed studies had demonstrated a “second-pass effect” – i.e., if you look a second time you will probably find more lesions. Reversing the order in group B provided a measure of that second-pass effect. Subtracting the additional detection rate with standard colonoscopy in group B from the additional detection rate with Third Eye colonoscopy in group A yielded the net additional detection rate that could be attributed to Third Eye colonoscopy.
• The study results showed that the net additional adenoma detection rate for Third Eye colonoscopy was 23.2% compared to standard colonoscopy.

“A growing body of clinical evidence shows that using the Third Eye Retroscope during colonoscopy can significantly increase adenoma detection rates compared to using the colonoscope alone,” said Jack Higgins, MD, Chief Medical Officer of Avantis Medical. “This evidence has convinced many key GI opinion leaders from around the world that the Third Eye is a valuable tool, and we believe that the increased detection and removal of these pre-cancerous polyps will provide a major benefit for patients.”

Two ACG poster presentations discussed sub-analyses of the TERRACE Study data, including single-center results from the Kansas City Veterans Affairs Medical Center as well as a comparison of the efficacy of the Third Eye Retroscope in older versus younger patients.

• Amit Rastogi, MD of the Kansas City Veterans Affairs Medical Center, University of Kansas School of Medicine, Kansas City, MO presented a poster titled, “Improvement in Adenoma Detection Using a Retrograde-Viewing Device During Colonoscopy in Subjects at a Veterans Affairs Hospital” (P1184). The single-center data indicated that Third Eye colonoscopy resulted in an additional adenoma detection rate of 40.5% compared to standard colonoscopy.
• Daniel C. DeMarco, MD of Baylor University Medical Center, Dallas, Texas presented a poster titled, “Improvement in Adenoma Detection Rates (ADR) with Use of a Retrograde-Viewing Device (Third Eye Retroscope) during Colonoscopy in Older versus Younger Patients” (P371), which found that Third Eye colonoscopy increased adenoma detection rates for patients regardless of age, with no statistically significant difference in results for those older than or younger than 65 years of age.

The Third Eye Retroscope was also featured in the ACG Hands-on-Learning Course led by Mark B. Pochapin, MD of New York – Presbyterian/Weill Cornell Medical Center.

About the Third Eye Retroscope and Avantis Medical Systems, Inc.

Avantis Medical Systems, Inc. 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. Deployed through the instrument channel of a standard colonoscope, the Third Eye provides the physician with a backward view to complement the colonoscope’s forward view of the lining of the colon. The device is commercially available to physicians who perform colonoscopies.

The Third Eye is the only technology cleared by the FDA that enhances polyp detection when used in conjunction with a colonoscope. Although colonoscopy is the gold standard for preventing colon cancer by finding and removing polyps and other lesions, clinical literature documents that up to 22-24% of pre-cancerous adenomas of all sizes(1,2) and 12% of adenomas over 10 mm in size(3) can be missed. Approximately 2/3 of missed lesions are hidden behind folds in the wall of the colon.(3) The Third Eye has been shown in clinical studies to help physicians find up to 25% more adenomas than a standard colonoscope alone.(4)

Avantis Medical 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, enhanced video processing and catheter-based delivery systems. For more information, visit www.AvantisMedical.com or www.ThirdEyeRetroscope.com.

(1) Rex DK, Cutler CS, Mark DG, 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) Pickhardt PJ, Nugent PA, Schindler WR, et al. Location of adenomas missed by optical colonoscopy. Ann Intern Med 2004;141:352-9. (4) DeMarco DC, Odstrcil E, Lara LF, et al. Impact of Experience with a Retrograde-Viewing Device on Adenoma Detection Rates and Withdrawal Times during Colonoscopy: the Third Eye Retroscope Study Group. Gastrointest Endosc 2010;71:542-50.

New Study Shows That the Third Eye(R) Retroscope(R) Improves Adenoma Detection by More Than 23 Percent Compared to Standard Colonoscopy

Tags: clinical evaluation, md phd, technology leader, adenomas, medical systems inc

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