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New Studies Show Given Imaging's SmartPill(R) Provides Standardized And Comprehensive Evaluation In Patients With Gastrointestinal Motility Disorders

SAN DIEGO, Oct. 14, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced results from two new studies that provide new information about gastroparesis, constipation and small intestinal bacterial overgrowth when using its SmartPill product. The studies were presented by researchers from the Cleveland Clinic and Texas Tech University Health Sciences Center at the American College of Gastroenterology's 2013 Annual Scientific Meeting (ACG) taking place October 11-16, 2013 in San Diego, California.

The SmartPill motility monitoring system offers a unique way to assess motility by collecting and analyzing data from within the entire GI tract via a test that can be performed in the clinic or physician's office. As the SmartPill capsule passes through the GI tract, it transmits data to a recorder worn by the patient. Once the single-use capsule has passed from the body, study data are downloaded from the recorder to a computer for evaluation by a physician.

"SmartPill provides clinicians with a powerful tool that helps us measure GI tract transit in patients who we cannot otherwise evaluate," said Zubin Arora M.D., Cleveland Clinic. "In our study, SmartPill revealed that many patients with symptoms suggestive of gastroparesis or constipation actually have more generalized gut dysmotility which definitely has implications for how we manage these patients therapeutically."
  • "Clinical Utility and Diagnostic Yield of 165 Wireless Capsule Studies at a Tertiary Referral Center," poster 1684: presented by Zubin Arora, M.D., and colleagues from the Cleveland Clinic, is a retrospective study of 165 patients with suspected motility disorders who underwent SmartPill studies. SmartPill provided the researchers with new information about bowel transit time that could aid patient management. In the study, SmartPill revealed abnormal findings in 78% of patients, including delayed large bowel transit time (39%), delayed gastric emptying time (35%) and delayed small bowel transit time (29%). In patients who received SmartPill for evaluation of gastroparesis, small bowel transit time was delayed in 39% of patients, and large bowel transit time was delayed in 28% of patients. Similarly, in patients who received a SmartPill test for evaluation of constipation, gastric emptying time was delayed in 27% of patients, and small bowel transit time was delayed in 25% of patients. 25% of patients suspected to have both gastroparesis and constipation had abnormal small bowel transit time. A large number of patients with abnormal gastric emptying scintigraphy also had abnormal small bowel transit time (36%) and large bowel transit time (41%). Similarly, many patients with abnormal Sitzmarks studies also had delayed gastric emptying time (50%) and delayed small bowel transit time (15%).    
  • " Does Small Intestinal Bacterial Overgrowth Delay Small Bowel Transit Time?," poster 767: presented by Irene Sarosiek, M.D., and colleagues from Texas Tech University, the investigators used SmartPill to explore the theory that symptoms of chronic idiopathic constipation may be related to alterations and abnormal colonization within the gut microbiata resulting in small intestinal bacterial overgrowth. The study found that small bowel transit time was 20% slower in patients with small intestinal bacterial overgrowth. After two weeks of treating the patients' constipation with lubiprostone, 37% no longer had small intestinal bacterial overgrowth and their small bowel transit time was reduced by 21%.

About SmartPill ® motility monitoring systems

The SmartPill motility monitoring system offers a unique way to assess motility by collecting and analyzing data from within the entire GI tract via a test that can be performed in the clinic or physician's office. The test is ambulatory, allowing the patient to go about their normal routine throughout the test. As the SmartPill capsule passes through the GI tract, it transmits data to a recorder worn by the patient. Once the single-use capsule has passed from the body, study data are downloaded from the recorder to a computer. The physician then uses MotiliGI ® software to display and analyze the data, providing test results in both graphical and report formats. Results are used for the evaluation of gastroparesis and chronic constipation. The SmartPill motility monitoring system was granted initial 510(k) release from the U.S. Food and Drug Administration (FDA) in July 2006.

SmartPill may not be a solution for every type of patient and is not indicated for children under the age of 18. The risks of SmartPill motility monitoring include capsule retention and aspiration. Patients should not have an MRI while SmartPill is in their body.

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