May 23, 2016 - 510(k) Clearance from FDA
Avantis Medical Systems Receives 510(k) Clearance from FDA for Resposable Third Eye® PanoramicTM Device for Colonoscopy
—Low cost, multi-use visualization device now available to endoscopists
to enhance quality of colonoscopy procedures —
San Jose, Calif. (May 23, 2016) –
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% 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 FDA clearance, the company plans to launch the product as a multi-use device and is currently evaluating strategic partnerships to drive commercial availability.
From left to right: (1) Panoramic device’s left-viewing camera, (2) Colonoscope’s forward-viewing camera, (3) Panoramic device’s right-viewing camera. The adenoma seen in this image was hidden from the colonoscope’s view but was detected with the Third Eye Panoramic.
About Colorectal Cancer
Colorectal cancer (CRC) 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 CRC each year and almost 50,000 die from it. Screening and surveillance colonoscopies allow CRC to be found earlier, when the disease is easier to cure, and cancers can be prevented if adenomas are removed before they become malignant.
Colonoscopy is the “gold standard” for detecting cancers and pre-cancerous adenomas in the colon. However, extensive research has shown that even when performed carefully by experienced physicians, standard colonoscopy misses approximately 24% of adenomas of all sizes.2-4 Even more importantly, standard colonoscopy misses 12% of large adenomas – measuring at least 1 cm in diameter – which are the ones most likely to progress to colon cancer.5-7
A number of factors have been shown to affect adenoma detection rates, including adequacy of bowel preparation and the amount of time spent examining the lining of the colon. However, approximately 2/3 of adenomas that are missed are located behind the numerous folds in the colon, where they are hidden from the forward view of the colonoscope.5 Adenomas and other abnormalities in those “blind spots” behind folds are easily missed with a standard colonoscope.
In fact, 7-8% of all cases of CRC are “interval cancers” – found within 2-3 years after the patient has had a “normal” colonoscopy.8 Previous research had shown that patients examined by endoscopists who have higher adenoma detection rates (ADR) have a lower likelihood of developing an interval cancer. More recently, a landmark study in the New England Journal of Medicine reported that for each 1% increase in an endoscopist's ADR, there is a 3% decrease in the risk of interval cancer and a 5% decrease in the risk for fatal interval cancer.9
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.
The Third Eye Panoramic device utilizes ground-breaking technology that was developed for the company’s first device, the Third Eye Retroscope, which was shown in clinical studies to help physicians find up to 23-25% more pre-cancerous adenomas than a standard colonoscope alone.7
The 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 designed to be used along with any standard adult or pediatric size colonoscope, so it avoids any substantial capital expense and it allows physicians to continue using the high-quality technologies in which their facilities have already invested, generally including colonoscopes with high-resolution or even high-definition video cameras.
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Lazar Partners for Avantis Medical Systems, Inc.
(646) 871-8480 / (917) 494-0227
Avantis Medical Systems, Inc.
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.
2. Rex DK, Cutler CS, Lemmel GT, et al. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology 1997;112:24-8.
3. 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.
4. 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.
5. Pickhardt PJ, Nugent PA, Mysliwiec PA, et al. Location of adenomas missed by optical colonoscopy. Annals of Internal Medicine 2004;141:352-60.
6. 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.
7. 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.
8. Cooper GS, Xu F, Barnholtz-Sloan JS, et al. Prevalence and Predictors of Interval Colorectal Cancers in Medicare Beneficiaries. Cancer 2012;118:3044-52.
9. Corley DA, Jensen CD, Mark AR, et al. Adenoma Detection Rate and Risk of Colorectal Cancer and Death. N Eng J Med 2014;370:1298-306.
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