SOURCE: Given Imaging

Given Imaging

November 13, 2009 08:00 ET

Multicenter Study Concludes That PillCam® SB Is Safe and Effective in Young Children

PillCam Capsule Endoscopy of the Small Bowel Offers Patient-Friendly Option for Diagnosing Young Children With Suspected Small Bowel Diseases

YOQNEAM, ISRAEL--(Marketwire - November 13, 2009) - Given Imaging Ltd. (NASDAQ: GIVN) today announced that a multi-center study published in the November edition of Gut showed PillCam capsule endoscopy of the small bowel to be just as useful and equally as safe in children under eight years old as it is in older children or adults. The prospective multicenter analysis was led by Annette Fritscher-Ravens M.D., Department of Interdisciplinary Endoscopy, University Hospital Kiel, Germany.

"Capsule endoscopy offers significant clinical value to younger patients who may have undergone multiple diagnostic procedures previously, without achieving a diagnosis," said Dr. Fritscher-Ravens. "Only with capsule endoscopy can we visualize the small bowel sufficiently to reach an accurate diagnosis in this very young patient population and begin treatment, ultimately improving the lives of these children."

"Often overlooked, these very young patients represent an important group of patients for whom accurate diagnosis and effective treatment can impact their lives significantly," said Homi Shamir, president and chief executive officer, Given Imaging. "We are proud to play a part in improving children's lives."

The study demonstrated that children as young as four years of age were able to swallow PillCam SB without any complications. The study also concluded that for children who were unable to swallow the capsule, a delivery device may be employed to place the capsule endoscopically.

About the Study

In this prospective study, physicians in nine centers studied eighty-three (83) children under eight years of age who had previously undergone routine endoscopy and radiological tests with inconclusive test results. The children suffered from a variety of small bowel disorders including: occult gastrointestinal bleeding, suspected Crohn's disease, abdominal pain of unknown etiology, protein-losing enteropathy and malabsorptive disorders. The PillCam capsule was either swallowed by the child or introduced endoscopically. Key findings included:

--  53% (16/30) of patients with obscure GI bleeding or chronic anemia had
    small bowel capsule endoscopy (CE) findings which identified the source of
    the bleeding. Six of these patients had been dependent on blood
    transfusions prior to the diagnostic test.
--  In 55% (11/20) of patients with suspected Crohn's, small bowel capsule
    endoscopy found evidence of small intestinal Crohn's disease despite prior
    negative upper and lower intestinal endoscopy.
--  50% (6/12) of patients with recurrent abdominal pain were found to
    have significant pathology.
--  Obscure GI bleeding was the most common indication, which differs from
    adolescent populations.
    

The study authors also noted that none of the patients retained the capsule; the smallest patient weighed only 10 kg.

The PillCam SB 2 video capsule, when used with the PillCam Platform, is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age and up. The PillCam SB 2 capsule and the PillCam Platform are not cleared for children younger than two years old and should not be used outside of the context of approved clinical trials with such patients.

About Given Imaging Ltd.

Since 2001, Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam capsule endoscopy provides physicians with natural images of the small intestine via PillCam SB, the esophagus through PillCam ESO and the colon with PillCam COLON [not cleared for use in the USA]. The PillCam capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile™ patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). Given Imaging's products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to better diagnose diseases of the esophagus, small bowel and colon and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia and Singapore. For more information, please visit http://www.givenimaging.com.

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