Healthcare Industry News:  endoscopy 

Devices Gastroenterology

 News Release - June 1, 2009

Study Concludes PillCam ESO(R) Correlates Well With EGD in Detecting and Grading Esophageal Varices -- A Potentially Lethal Complication of Advanced Liver Disease

CHICAGO, IL--(Healthcare Sales & Marketing Network)--Jun 1, 2009 -- Given Imaging Ltd. (NasdaqGM:GIVN ) today announced the results of a study showing that capsule endoscopy with PillCam® ESO demonstrated good correlation with upper endoscopy as a tool to diagnose and grade esophageal varices (EVs), a potentially lethal complication of advanced liver disease. In addition, since PillCam ESO requires no sedation and is substantially less invasive than esophagogastroduodenoscopy (EGD), study investigators suggested that patients may be more willing to comply with the need to get screened regularly to prevent potentially lethal gastrointestinal hemorrhage. Neil R. Sharma, M.D., Division of Digestive Diseases and Nutrition, University of South Florida in Tampa, presented the findings in a poster presentation (#S1829) at the annual Digestive Disease Week® (DDW) 2009 conference, taking place in Chicago from May 30 - June 4.

"Detecting and monitoring varices is critical in this patient population," said Dr. Neil R. Sharma. "Requiring no sedation, esophageal capsule endoscopy provides a less invasive but equally effective option for the screening of esophageal varices."

The current standard of care for screening, esophagogastroduodenoscopy, also called EGD or "upper endoscopy," is invasive and requires sedation, which may limit adherence to screening programs(1). Fifty percent of cirrhotic patients develop varices within 10 years(2). Ten to twenty percent of patients whose varices hemorrhage, or bleed, die within six weeks(3).

About the Study

This prospective study enrolled 34 patients with end-stage liver disease who underwent esophageal capsule endoscopy and EGD on the same day. Each capsule endoscopy study was evaluated by a gastroenterologist experienced in reading and interpreting these studies, and physicians were blinded to the results. EVs were graded as absent, small, medium or large. EGD was considered to be the gold standard for the purposes of the study. Key findings included:

-- Esophageal capsule endoscopy had sensitivity and specificity of 100 and 66.7 percent, respectively, compared to EGD in the detection of esophageal varices;

-- Complete agreement of EV grade occurred in 73.5 (25 of 34) percent of cases;

-- Two of twelve patients whose EV were evaluated as "medium" or "large" by capsule endoscopy were evaluated to be "small" using EGD; 1 of 18 patients whose EV was evaluated as "small" using esophageal capsule endoscopy was evaluated as "medium" with EGD;

-- Evaluation of stigmata, a specific diagnostic sign of potential bleeding, with capsule endoscopy showed sensitivity and specificity of 92.6 and 85.7 percent, respectively; and

-- Based on minimal invasiveness, lack of need for sedation, less discomfort and fewer side effects, ESO may be a more desirable procedure for cirrhotic patients that need EV screening.

About Esophageal Varices

Chronic liver disease affects 360 out of every 100,000 people in the U.S., results in 300,000 hospitalizations annually and costs more than $2 billion a year, according to the National Institutes of Health. The two most common diseases leading to varices 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 (enlarged veins) are two of the main complications of the disease.

In advanced cases of liver cirrhosis, scar tissue spreads and restricts the blood from flowing through the liver. This can cause the veins in the esophagus to enlarge. It is vital to monitor for the appearance of these enlarged veins, or varices, and to keep track of their size.

About PillCam ESO

Cleared by the U.S. Food and Drug Administration in November 2004 to visualize the esophagus in adult patients in a patient-friendly way, physicians can use PillCam ESO to aid in the detection of disorders such as Barrett's esophagus, a potential precursor for esophageal cancer and esophageal varices, which if left untreated, can result in fatal bleeding. Now in its second generation, PillCam ESO 2 contains imaging devices and light sources at both ends of the capsule that capture up to 18 images per second as it passes down the esophagus in a twenty-minute procedure.

About 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, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 30 - June 4, 2009, at the McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit

About Given Imaging Ltd.

Since 2001, Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam capsule endoscopy provides physicians with natural images of the small intestine via PillCam® SB, the esophagus through PillCam® ESO, and the colon with PillCam® COLON [PillCam COLON is not cleared for use in the USA]. The PillCam capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile(TM) patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). Given Imaging's products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to better diagnose disease of the esophagus, small bowel and colon [PillCam COLON is not cleared for use in the USA] and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia and Singapore. For more information, please visit

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) our ability to develop and bring to market new products, (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of significant litigation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, (11) the impact of global economic conditions, and (12) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2008. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

(1) Roberto de Franchis, M.D., et al., Esophageal Capsule Endscopy for Screening and Surveillance of Esophageal Varices in Patients with Portal al., Hepatology 2008; 47: 1595-1603.

(2) D'Amico G, Pasta L, Madonia S, et al. The incidence of esophageal varices in cirrhosis. Gastroenterology 2001;120:A2.

(3) D'Amico G, de Franchis R, and the Cooperative Study Group. Upper digestive bleeding in cirrhosis: post-therapeutic outcomes and prognostic indicators. Hepatology 2003;38:599-612.

Source: Given Imaging

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