Studies demonstrate clinical utility of Given Imaging's PillCam SB capsule endoscopy

Given Imaging Ltd. (NASDAQ: GIVN), the global leader in patient-friendly GI diagnostic and monitoring solutions, today announced three new studies that demonstrate the clinical utility of PillCam SB capsule endoscopy in providing physicians with critical information on how they manage and/or diagnose intestinal disorders. These novel studies were carried out in pediatric patients with gastrointestinal symptoms, including children with known or suspected Crohn's disease. The three studies were presented at the Gastro 2009 conference taking place in London from November 21 to 25. Given Imaging is exhibiting at booth #83 at the conference.

In presentation # OP182, Professor Annette Fritscher-Ravens, Department of Interdisciplinary Endoscopy, University Hospital Kiel, Germany, concluded that physicians should consider wireless capsule endoscopy exams for children under eight years of age when other diagnostic methods failed to identify the cause of their GI symptoms. Physicians participating in this study changed the clinical management 100 percent of the time when capsule endoscopy studies revealed pathology. The study also concluded that negative findings may be as useful as positive findings in influencing the patient management plan.

"Capsule endoscopy is a powerful, non-invasive imaging modality that can impact pediatric patient outcomes," said Dr. Fritscher-Ravens. "If no cause for symptoms can be determined, capsule endoscopy should always be considered, as both positive and negative findings from CE exams have led us to change how we manage pediatric patients, which often improves their quality of life."

The second, a poster presentation (P1369) led by Dr. Ernest G. Seidman, Professor of Medicine and Chair of IBD at McGill University Health Center, Montreal, Canada, concluded that capsule endoscopy is clinically useful in symptomatic pediatric patients with known Crohn's disease when endoscopic and barium studies are negative. As a result of the CE findings, study investigators changed how they clinically managed more than half of the patients in the study.

"For those children with Crohn's disease who still experience symptoms, we have learned capsule endoscopy findings can alter the way we manage their disease," said Dr. Seidman. He went on to state, "This included important management decisions, such as using anti-TNF monoclonal antibody therapy rather than proceeding with surgery."

A third poster presentation (P0195) led by Salvatore Cucchiara, MD, PhD, Pediatric Gastroenterology Unit, Sapienza University of Rome, concluded that information from PillCam SB procedures can help classify IBD as either Crohn's disease, ulcerative colitis or unclassified IBD among children. These results were determined to have important clinical and therapeutic implications.

"Children remain an important patient group for whom accurate diagnosis and treatment can significantly impact their lives, and we are pleased that these studies validate PillCam SB's broader role in their diagnosis and management," said Homi Shamir, President and Chief Executive Officer, Given Imaging.