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Published on 11/2/2005 in the Prospect News Biotech Daily.

Given Imaging's PillCam effective in diagnosing gastrointestinal ailments, studies say

By Angela McDaniels

Seattle, Nov. 2 - Given Imaging Ltd. said that three independent studies of its PillCam SB showed that capsule endoscopy not only identifies small bowel tumors and previously undetected Crohn's disease, it also leads to meaningful changes in patient management.

The studies were presented at the 70th Annual Scientific Meeting of the American College of Gastroenterology in Honolulu.

Anthony Infantolino of Thomas Jefferson University in Philadelphia reviewed files of 366 patients that underwent capsule endoscopy after inconclusive upper and lower endoscopies. Of these, a cause for the obscure gastrointestinal bleeding was identified in 83%, Given said.

The study concluded that capsule endoscopy is effective in investigating gastrointestinal bleeding, with small bowel tumors being discovered at a rate higher than previously reported, the company said.

Sidney Cohen, also of Thomas Jefferson University, looked at the same files, but focused on the overall experience of capsule endoscopy. Given said his results showed that the PillCam identified a cause of bleeding in 77% of patients, as well as a possible cause of abdominal pain and diarrhea in 42% and 28% of patients, respectively.

Cohen also found capsule endoscopy efficacious in evaluating early Crohn's disease.

Kevin Olden of the University of South Alabama in Mobile conducted a retrospective study of 210 cases to determine whether capsule endoscopy findings led to a change in patient management.

Overall, Olden concluded that capsule endoscopy led to a change in patient management in 39% of the cases reviewed. In obscure-occult bleeding patients, the number increased to 42%. The study also concluded that capsule endoscopy findings reassure patients and eliminate the need for further testing, Given said.

"Recent large studies with consistent clinical data continue to support the use of PillCam capsule

endoscopy as a first-line diagnostic tool for patients who suffer from unresolved gastrointestinal symptoms," said Gavriel D. Meron, president and chief executive officer of Given Imaging.

"As additional evidence-based studies emerge, we anticipate that payers will update and expand their coverage policies to reflect these new data."

Given Imaging is biotechnology company based in Yoqneam, Israel, that develops products for detecting gastrointestinal disorders.


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