Trial Finds Capsule Endoscopy Safe and Effective for Pediatric Use

Results of the first study in pediatrics presented at Digestive Disease Week 2003 shows capsule endoscopy to be more accurate and patient-friendly than traditional imaging modalities

Orlando, FL - (May 20, 2003) - Clinicians from Sainte Justine Hospital in Montreal announced today that their recently completed study demonstrated that the M2A® capsule endoscope can safely and accurately diagnose small bowel disorders in children. The results of the study, presented at Digestive Disease Week (DDW) 2003, demonstrate that capsule endoscopy offers a more accurate and non-invasive approach for diagnosing small bowel disorders in children over the age of ten when compared to traditional imaging modalities. Ernest G. Seidman, M.D., Chief, Division of Gastroenterology, at Sainte-Justine Hospital in Montreal, and his team conducted this comparative, self-controlled study involving 30 pediatric patients between the ages of 10 and 18.

"Based on the results of the study, capsule endoscopy is a safe and more effective diagnostic tool for pediatric patients older than 10 who suffer from obscure small bowel disorders not diagnosed by other imaging modalities," said Dr. Ernest G. Seidman. "In light of the growing body of positive clinical data from use of the capsule endoscope in adults, we are pleased that children and adolescents can also benefit from the technology’s superior diagnostic and validation capabilities."

The study aimed to evaluate the sensitivity, specificity and global diagnostic value of the M2A diagnostic system in identifying specific occult small bowel disorders in children and adolescents. Thirty pediatric patients suspected of having small bowel disorders, including occult Crohn’s disease, intestinal polyposis and obscure GI bleeding were examined. The trial compared the results of the videocapsule procedure for each case with the corresponding traditional imaging for the above three disorders. The capsule endoscope was well tolerated by all patients and no adverse effects were reported.

Of the thirty patients studied, the capsule endoscope correctly diagnosed or definitely excluded a bleeding source, small bowel polyps or Crohn’s Disease in twenty-nine cases. In the one remaining case, the patient spontaneously stopped bleeding during the course of the trial and no diagnosis was made using any type of imaging procedure. This is the first clinical trial of the M2A capsule in children. The U.S. Food and Drug Administration (FDA) has not yet reviewed the M2A capsule for pediatric use.

The study is the subject of an American Gastroenterological Association (AGA) Topic Forum (publishing ID 139) and Postgraduate Course (publishing ID Sp73) as well as an American Society for Gastrointestinal Endoscopy (ASGE) Clinical Symposium (publishing ID Sp401).

About Sainte Justine Hospital
The mission of the Sainte-Justine Mother-Child University Health Centre is to offer children, teenagers and mothers healthcare on a par with the best in the world. The hospital also does leading-edge research in all areas of mother and child health, and focuses on health promotion and university training for physicians and other health professionals. Sainte-Justine's is also a leader in assessing new, less invasive healthcare technologies for children.

About Capsule Endoscopy
The M2A® Capsule, a fundamentally new approach to examining the gastrointestinal tract, is manufactured and marketing by Given Imaging (NASDAQ: GIVN). The system uses a disposable miniature video camera contained in a capsule that is ingested by a patient, delivering high quality color images in a painless and non-invasive manner. The test can be conducted while a patient carries out their normal daily activities. The system received clearance from the FDA for use in adults in August 2001 and received permission to affix the CE mark in May 2001. The system is currently being marketed in 41 countries worldwide, including the USA, Canada, Europe, Central and South America, and Asia. Many thousands of patients suffering from diseases in the small intestine such as Crohn’s, celiac disease, unexplained abdominal pain with diarrhea, polyposis, intestinal tumors, iron deficiency anemia and obscure bleeding have already benefited from this innovative technology. For more information, visit www.givenimaging.com.

About DDW
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 17-22, 2003 in Orlando, Florida. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

19.Sept.'03