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Given Imaging Announces New European Study Evaluating PillCam(R) COLON Versus CT-Colonography In Patients With Incomplete Colonoscopy

Other studies confirm PillCam COLON useful in detecting flat lesions and evaluating pediatric ulcerative colitis Additional comparative trial finds capsule endoscopy superior to Magnetic Resonance Enterography in detecting small bowel Crohn's disease lesions

ORLANDO, Fla., May 20, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced data from several European studies confirming the effectiveness of PillCam COLON in detecting colonic lesions in patients following incomplete colonoscopies and monitoring diverse digestive diseases in both adults and children. All data are being presented during Digestive Disease Week (DDW) taking place May 18 - 21, 2013 at the Orange County Convention Center, Orlando, FL. Given Imaging is exhibiting at booth #1059 throughout the conference.

"Clinical evidence continues to highlight the accuracy of PillCam COLON in providing direct visualization of the colon," said Cristiano Spada, M.D., Catholic University, Rome, Italy. "The analysis data from our prospective trial show that PillCam COLON can be beneficial and effective for patients with previous incomplete colonoscopies. We welcome new diagnostic tools that provide us with a solution for this patient segment."

Dr. Spada presented the analysis, "Prospective Trial of PillCam COLON versus CT-Colonography (CTC) in the Evaluation of Patients with Incomplete Conventional Colonoscopy (CC)" (Podium presentation 703). After undergoing traditional colonoscopies that were unable to be completed for various reasons, 100 patients had PillCam COLON and CTC exams to determine how well doctors using each method were able to visualize areas of the colon that couldn't be seen with the incomplete colonoscopy. PillCam COLON and CTC enabled physicians to see additional areas beyond colonoscopy in 98% of the patients. The results of this study suggested that both PillCam COLON and CTC are effective in patients with incomplete colonoscopies, however, PillCam COLON tends to detect more polyps than CTC in segments of the colon that were not visualized by incomplete colonoscopies. 

Separately, Dr. Spada presented the results of a retrospective study, "Flat Colorectal Lesions At PillCam Colon Capsule Endoscopy (CCE)" (Podium presentation 857), that indicates that PillCam COLON has high accuracy for detecting flat lesions, which have been shown to carry a higher risk for cancer. The retrospective study collected data from patients who underwent PillCam COLON followed by an optical colonoscopy, which is considered the gold standard tool for colorectal cancer detection. Physicians were able to identify 27 conventional polyps with colonoscopy, while they found 25 conventional polyps with PillCam COLON. In one patient, PillCam COLON visualized an 11 mm flat lesion that was not confirmed by colonoscopy. PillCam COLON generated 90% sensitivity and 96% specificity on a per-lesion basis.

The value of PillCam COLON was also confirmed in " Evaluation of the Second Generation Colon Capsule Endoscopy (CCE-2) in Pediatric Ulcerative Colitis (UC)" (Podium presentation 689). Thirty pediatric patients with known ulcerative colitis underwent PillCam COLON and colonoscopy exams to determine how well each method helps physicians detect inflammation in the colon. Blinded results from the procedures showed 95% sensitivity for PillCam COLON to detect colonic inflammation and 100% specificity in accurately ruling it out. Based on the comparability of PillCam COLON to standard colonoscopy, investigators led by Salvatore Oliva, M.D. concluded that PillCam COLON is a very useful, safe and well-tolerated procedure to monitor disease activity and progression in children. Dr. Olivia and his team also suggested that given the noninvasive and patient-friendly characteristics of the PillCam COLON, it could have an impact on the diagnostic work-up of children with ulcerative colitis. Dr. Oliva practices at the Pediatric Gastroenterology and Liver Unit at the Sapienza University of Rome in Italy.

"The application for capsule endoscopy continues to develop as emerging data suggest the use of this minimally-invasive, patient-friendly technology," said Begoña Gonzalez-Suarez, M.D., Ph.D., Clinic Hospital, Barcelona, Spain. "PillCam SB and PillCam COLON are particularly useful modalities to directly visualize the small bowel and colon for lesions related to growing disease state areas, such as Crohn's disease."

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