The FDA noted that in a trial conducted in New York, the Given® Imaging Diagnostic System detected physical
abnormalities in 12 of 20 patients, or 60%, while push enteroscopy detected physical abnormalities in 7 of 20 patients,
or 35%. In total, 14 lesions were detected in 13 of the 20 patients participating in the clinical trials using either the
Given¨ Imaging Diagnostic System, push enteroscopy or surgical techniques. The Given® Imaging Diagnostic
System detected 12 of the 14 lesions, or 86%, while push enteroscopy detected 7 of 14, or 50%.
The FDA also noted that the Given® system was able to identify sources of bleeding in five cases that were beyond
the reach of the traditional enteroscope.
The trial included 20 patients with suspected small intestine disorders. All 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, said, "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."
Previously, physicians in France, Italy, Spain, Belgium, and Germany were the first to use Given Diagnostic Imaging
Systems to painlessly visualize the entire length of patient's small intestine. As a result of the company's receiving a
CE Mark, declaring the system "safe and that it performs satisfactory " which allows the company to market the
M2A* imaging capsule and system to physicians within European Union countries.
The United States Food and Drug Administration on August 1 cleared the marketing in the U.S. of a swallowable
video capsule for use in diagnosing disorders in the small intestine.