Given Imaging Announces Publication in Gastrointestinal Endoscopy Showing Capsule Endoscopy Superior to Push Enteroscopy

9/13/2002 - Atlanta -- Given Imaging (Nasdaq: GIVN) announced today that a study published in the latest issue of Gastrointestinal Endoscopy (September 2002, Volume 56, Number 3) concluded that the companys M2A capsule endoscope identified small intestinal bleeding sites beyond the range of push enteroscopy. The study also concluded that capsule endoscopy provides excellent visualization of the small intestine, and is well tolerated and safe. The study was conducted by Blair Lewis, M.D., of Mount Sinai Hospital New York and Paul Swain, M.D., of The Royal London Hospital, and formed the basis of FDA approval of the M2A capsule in 2001.

"Peer review publications like this help to validate and advance understanding about the clinical efficacy of capsule endoscopy and should continue to expand its use among gastroenterologists," said Dr. Gavriel Meron, President and CEO of Given Imaging Ltd.

The article reports results of the trial involving 21 patients between the ages of 21 and 80. A bleeding site was found in 11 of 20 patients during the capsule endoscopy procedure. No additional intestinal diagnoses were made by enteroscopy. The yield of push enteroscopy in the evaluation of obscure bleeding was 30% versus 55% for capsule endoscopy.

An accompanying editorial by Dr. David E. Fleischer, Chief of Gastroenterology & Hepatology at The Mayo Clinic in Scottsdale, AZ, stated that capsule endoscopy provides a new paradigm for endoscopy and medicine, and emphasized that it does not require the patient to be in a medical facility when the test is being conducted. It also underscored the need for additional studies beyond this initial study. "Capsule endoscopy is a revolutionary addition to the armamentarium of GI diagnostic studies and will replace some of the current examinations as the new standard of care," stated Fleischer.

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19.Sept.'03