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Given Imaging Announces Data Confirming PillCam(R) SB Improves Monitoring And Management Of Crohn's Disease

-- Additional Study Highlights Improved Diagnostic Yield for New 12-Hour PillCam SB --

-- Celebrates Two Millionth PillCam Milestone --

ORLANDO, Fla., May 21, 2013 (GLOBE NEWSWIRE) -- Given Imaging (Nasdaq:GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced new studies that confirm the value of PillCam SB in diagnosing, monitoring and managing patients with known or suspected Crohn's disease and other conditions of the small bowel. The studies were presented at Digestive Disease Week ® (DDW), taking place May 18-21, 2013, at the Orange County Convention Center, Orlando, FL, where Given Imaging is exhibiting at booth #1059 throughout the conference.

"PillCam SB has long been regarded as an important tool for detecting diseases in the small bowel," said Neel K. Mann, M.D., Associate Director, Small Bowel Enteroscopy, Cedars-Sinai Medical Center. "The exciting new studies being presented at this year's DDW further confirm the utility of small bowel capsule endoscopy in helping physicians monitor mucosal healing in patients with Crohn's disease, and therefore improving outcomes."

Several DDW poster presentations underscore the clinical utility of using PillCam SB in patients with Crohn's disease and PillCam SB's positive impact in improving disease management including:
  • Wireless Capsule Endoscopy Improves Outcomes in Nonstricturing Crohn's Disease: An Evaluation of Pre- and Post- Treatment Capsule Endoscopy (CE), poster Sa1634, presented by Neel K. Mann, M.D., M.P.H. and Simon K. Lo, M.D. Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA. This retrospective review showed that capsule endoscopy was able to re-classify disease phenotype in >60% of patients with suspected Crohn's disease or unclassified Inflammatory Bowel Disease, thereby potentially changing the management outcome of these patients. More importantly, capsule endoscopy demonstrated mucosal healing in >70% patients, after assessment of therapy, positively changing disease outcome and achieving therapeutic goal in patients with non-stricturing phenotype.  
  • Small Bowel Capsule Endoscopy for Assessing Early Postoperative Recurrence of Crohn's Disease: A Prospective Longitudinal Study, poster Su1199, presented by researchers at the Università Tor Vergata, Roma, Italy, analyzed the value of small bowel capsule endoscopy in assessing early postoperative Crohn's Disease recurrence when using ileocolonoscopy (IC) as gold standard. The study concluded that early after surgery for Crohn's disease, small bowel capsule endoscopy can visualize superficial upper GI lesions in select patients that standard techniques do not detect.  
  • Usefulness of Lewis Score of Capsule Endoscopy in Japanese Patients with Crohn's Disease, poster Tu1350, presented by Sadaharu Nouda, M.D., Ph.D., Department of Internal Medicine, Osaka Medical College, Osaka Japan, and colleagues, analyzed the data from 46 patients with Crohn's disease who underwent capsule endoscopy (CE). The study's aim was to assess the usefulness of the Lewis Score (LS) of CE in standardizing the reporting of small bowel inflammation in Crohn's patients with small bowel lesions. The investigators examined two issues: 1.The correlation between the LS and blood data and that between the LS and Crohn's disease activity index and 2. Analysis of the LS in patients with clinical remission defined as CDA1<150. The study found that CE is useful in patients with Crohn's disease. Further results showed that since clinical remission is not always associated with endoscopic remission, the Lewis Score is also useful in patients with Crohn's disease.

An additional study, 8-Hour CE Versus 12-Hour CE in a Cohort of Hospitalized Patients Undergoing CE for Suspected Small Bowel Disorders, poster Tu1301, presented by Rafiul S. Islam, M.D., Mayo Clinic, Scottsdale, AZ, and colleagues, compared the diagnostic yield and completion rates of 8-hour capsule endoscopy (CE) and 12-hour CE in a cohort of hospitalized patients. The study sought to determine patient characteristics associated with an incomplete CE and define an association with the type of lesions found. Results show that a previous inability to reach the cecum using the 8-hour capsule was accomplished with the 12-hour capsule. Furthermore, the 12-hour capsule produced significantly higher diagnostic yields compared with the 8-hour capsule, even though there was no difference in the completion rates between the two capsules. Incomplete examinations were more common in non-obese patients, and were not influenced by diabetes, narcotic use, motility disorders, or gender.

During DDW, Given Imaging will also be celebrating that more than two million PillCam capsules have been used in patients around the world. This major company milestone underscores capsule endoscopy's profound medical impact.

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