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| |  PillCam ESO Comparable to Upper Endoscopy in Detecting Esophageal Varices and Portal Hypertension in Cirrhotic Patients Patients prefer PillCam ESO as screening method for varices YOQNEAM, ISRAEL -- February 8, 2006 -- Given Imaging Ltd. today announced that two independent studies concluded that PillCam(TM) ESO is an accurate, noninvasive alternative to upper endoscopy, the current "gold standard" for evaluating patients and the most commonly performed procedure in detecting esophageal varices in cirrhotic patients. Both prospective studies were published in the January issue of Endoscopy, the official publication of the European Society of Gastrointestinal Endoscopy. Chronic liver disease affects 360 out of every 100,000 people in the U.S., results in 300,000 hospitalizations annually and costs over $2 billion a year according to National Institutes of Health. The two most common diseases are cirrhosis and fibrosis of the liver. In cirrhosis of the liver, scar tissue replaces normal, healthy tissue, blocking the flow of blood through the organ and preventing it from working as it should. Portal hypertension and esophageal varices are two of the main complications of the disease. Gavriel D. Meron, president and CEO of Given Imaging said, "Both American and European societies recommend that cirrhotic patients be screened to detect esophageal varices and portal hypertension. We believe this data will prove interesting to insurers and lead them to reimburse for PillCam ESO as a screening tool for these indications." The first study was led by researchers from the Oregon Health and Science University in Portland, the Department of Internal Medicine of the University of Milan, Italy, and the Department of Gastroenterology at Rambam Medical Center in Haifa, Israel. The multi-center, multi-national pilot study of 32 cirrhotic patients assessed PillCam ESO's ability to detect esophageal varices when compared to upper endoscopy in cirrhotic patients. The study also evaluated patients' tolerance and preference for each technique. It was concluded that PillCam ESO detected varices in 23 patients and signs of portal hypertension in 19 patients, matching the upper endoscopy findings. The patients studied also felt that PillCam ESO was more convenient and less uncomfortable than the standard endoscopy examination. Glenn Eisen, MD, lead author and Associate Professor of Medicine and Clinical Director of Gastroenterology, Oregon Health and Science University, said, "The results confirm that the capsule endoscopy technique is an accurate, safe, well-tolerated, rapid alternative screening method to detect esophageal varices without the need for conscious sedation and the costs associated with it." A second study led by Professor Thierry Ponchon, of Edouard Herriot Hospital in Lyon, France assessed 21 cirrhotic patients to determine the accuracy of PillCam ESO and how well patients tolerate the procedure compared to upper endoscopy for portal hypertension screening. The researchers concluded that there was complete diagnostic agreement on the presence or absence of esophageal varices in 85% patients. The study showed that the sensitivity of PillCam ESO for all large varices which require treatment was 100%. The study also reported that all 20 patients who swallowed the capsule preferred PillCam ESO.
SOURCE: Given Imaging Ltd.
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