Given Imaging's Capsule Imaging Technology market-cleared in the European Union, USA, Australia, and Israel

Yoqneam 01 August 2001Physicians and patients in the European Union, the United States of America, Australia, and Israel will now be able to benefit from a new medical technology which allows doctors to visualise the entire length of the small intestine using a minute camera contained in an easily-swallowed capsule. The Israeli company Given Imaging Ltd., which manufactures the diagnostic system, has received official approval to market the video capsule to physicians within European Union countries thanks to the granted CE Mark, Australia, and Israel. In addition, the United States Food and Drug Administration (FDA) cleared the marketing of the camera-capsule in the U.S. for use in diagnosing disorders in the small intestine.

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The Given Diagnostic Imaging System consists of the patented tiny and ingestible M2A video colour-imaging capsule; a data recorder worn on a belt by the patient, which receives all data transmitted by the capsule; and the RAPID Workstation to process the patient data and produce short video clips of the small intestine, together with other relevant images from the gastrointestinal tract. Until this system was available, doctors relied on other technologies, including push enteroscopy, in which a camera attached to a flexible wand or endoscope, was inserted through the patient's mouth and guided into the small intestine. Patients undergoing push enteroscopy typically require sedation and the procedure allows a physician to view only a portion of the small intestine.

In an FDA-organised trial conducted in New York, the Given Imaging Diagnostic System detected physical abnormalities in 12 patients, or 60 percent, while push enteroscopy detected physical abnormalities in 7 of 20 patients, or 35 percent. In total, 14 lesions were detected in 13 of the 20 patients participating in the clinical trials using either Given Capsule Imaging Technology, push enteroscopy, or surgical techniques. The Given Imaging Diagnostic System detected 12 of the 14 lesions, or 86 percent, while push enteroscopy detected a number of 7 out of 14, or 50 percent. The FDA also noted that the Given system was able to identify sources of bleeding in five cases which were beyond the reach of the traditional enteroscope.

The trial included 20 patients with suspected small intestine disorders. All these patients had previously undergone multiple gastrointestinal endoscopies and radiological procedures to identify the source of their small intestinal disorders, without a conclusive diagnosis. Blair S. Lewis, M.D., associate clinical professor of medicine at Mount Sinai School of Medicine in New York and a member of Given Imaging's Medical Advisory Board, who headed the clinical trials, commented: "In my study, the M2A capsule was able to identify pathologies in the small intestine that were not identified by standard methods. Additional diagnoses were made in some of the cases, thereby positively changing patient management. Also, because the procedure is non-invasive, patients showed a definite preference for the capsule over push enteroscopy."

The system is also currently being used in clinical trials in Belgium, France, Germany, Italy, and Spain. "The Given Diagnostic Imaging System lets us view the entire small intestine in a natural environment and allows us to document, to study and evaluate segments of the digestive system which until now were impossible to evaluate", stated Professor F.P. Rossini of St. Giovanni Hospital in Turin, Italy. Professor Rossini is the principal investigator for clinical trials performed in Turin, Milan, and Rome. The Given system will be available to doctors in selected markets within 90 days of placing an order, according to Harald Beyer, Vice President European Operations. More news on this new medical imaging technology can be found in the VMW August 2000 article Swallowable camera-capsule to visualise gastrointestinal tract from patient's interior.


Leslie Versweyveld

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