"We are in the final stages of our clearance process with the FDA to market PillCam COLON for the detection of polyps in patients following incomplete colonoscopy, which we believe represents a sizable initial opportunity for PillCam COLON as an additional tool for gastroenterologists that does not require sedation or radiation and allows them to deliver the best possible care to their patients," said Homi Shamir, President and CEO, Given Imaging. "This adenoma detection analysis underscores the great potential we see for future expanded indications for PillCam COLON after the initial clearance is obtained. These data build upon the extensive clinical experience that gastroenterologists outside of the U.S. have already had with PillCam COLON and we continue to advance regulatory approval for PillCam COLON in other major countries around the world in a range of diseases of the small bowel and colon."
PillCam ® COLON is under review with the FDA, and is not cleared for marketing or available for commercial distribution in the U.S.A. and there is no assurance that such clearance will be obtained.
Dr. Douglas Rex is a paid consultant of Given Imaging.
In an additional study presented at DDW, poster presentation Tu1316, French Muticentric Experience of Colon Capsule Endoscopy in Real Practice : Primary Results of the Colon Capsule Endoscopy Observatory "ONECC", investigators led by Jean Christophe Saurin, M.D., Ph.D., Hospices Civils de Lyon, Lyon, France, evaluated the feasibility of PillCam COLON in a general practice setting and also in a variety of populations including in patients who had a failed colonoscopy, are contra-indicated for colonoscopy or those who refused colonoscopy. The observational study collected data from 94 centers enrolled in the French national colon capsule endoscopy network (ONECC). From these centers, PillCam COLON identified 233 polyps in 108 of the 245 subjects. Significant polyps, defined as polyps larger than 5 mm or cases of at least 3 polyps, were detected in 22.9% of patients with a failed colonoscopy, 30.2% in patents contra-indicated for colonoscopy and 15.1% of patients who refused colonoscopy. Researchers concluded that it is feasible to use PillCam COLON in a general practice setting and that PillCam COLON has a significant clinical impact on the detection of colonic polyps in diverse patient populations.Financial Community Meeting and Webcast Given Imaging will host a financial community meeting and webcast on Tuesday, May 21, 2013 at 10:00am ET, 5:00pm Israel time to review highlights of the PillCam COLON pivotal trial data and other highlights from DDW. A live audio webcast will be available in the investor relations section of the company's website, www.givenimaging.com . To participate in the live teleconference, please dial the following numbers approximately fifteen minutes prior to the start of the meeting: U.S. and Canada, 877-334-1964 (toll-free); callers in other countries should dial, 631-291-4574 (toll charges apply). The archived webcast will be available for thirty days on the company's website. About PillCam ® COLON The PillCam COLON video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11 mm X 31 mm. PillCam COLON is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.
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