SAN JOSE, Calif., Feb. 16, 2016 (GLOBE NEWSWIRE) -- Avantis Medical Systems, Inc., a technology leader in developing novel digital imaging devices, today announced that it has submitted a 510(k) to the U.S. Food & Drug Administration (FDA) that would allow its Third Eye® Panoramic™ device to be used as a resposable product for colonoscopies.
Photos accompanying this announcement are available at
The FDA has notified the company that the submission has passed its administrative acceptance review and that they are now proceeding with the substantive review. Pursuant to Section 510(k), the FDA has 90 days in which to clear the Class II medical device for commercial distribution or to seek additional information from Avantis. Following notification of the clearance, Avantis would immediately be able to commence manufacturing, marketing and sales of the product. The company is evaluating strategic alternatives for purposes of commercialization.
The Third Eye Panoramic is designed to help physicians see behind folds in the wall of the colon that can hide pre-cancerous polyps called adenomas. Previously cleared by the FDA in November 2014 as a disposable product, Avantis recently reengineered the device to make it resposable (safe to use multiple times prior to disposal). This offers physicians an efficient, cost-effective solution to improve the quality of colonoscopy, a critical procedure for detecting colorectal cancer or even preventing it by finding and removing tissue that might become malignant later. Based on clinical experience, physicians reported that when using the Third Eye Panoramic they were able to detect pre-cancerous adenomas in 44% of patients.1
“In today’s healthcare environment, it is not enough just to raise the quality of procedures and thereby improve patient outcomes. The best innovations also help healthcare providers to contain costs,” said Anthony DiTonno, CEO of Avantis Medical Systems. “The resposable version of the Third Eye Panoramic device will provide physicians a cost-effective option to improve visualization during colonoscopies, which we believe will be an important contributing factor to broaden adoption of this important technology.”
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 it can be used during both the insertion and withdrawal phases. The 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.
The cleaning and disinfection protocols under review by the FDA are similar to the methods used to reprocess colonoscopes between uses.
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 with 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.
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.
Lazar Partners for Avantis Medical Systems, Inc. Chantal Beaudry (646) 871-8480 / (917) 494-0227 email@example.com Avantis Medical Systems, Inc. Anthony DiTonno (408) 636-7260 firstname.lastname@example.org
Source:Avantis Medical Systems