Healthcare Industry News: Capsule Endoscopy
News Release - May 31, 2007
New Data Support PillCam(R) ESO as a Non-Invasive Alternative to Upper Endoscopy for Detection of Esophageal VaricesDemonstrated Utility in Screening and Surveillance of Esophageal Varices
YOQNEAM, ISRAEL, and CHICAGO, IL--(Healthcare Sales & Marketing Network)--May 31, 2007 -- Given Imaging Ltd. (NasdaqGM:GIVN ) and INSCOPE, a division of Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, today announced results of an international multi-center trial demonstrating that esophageal Capsule Endoscopy with PillCam® ESO is comparable to upper endoscopy (EGD) for detecting esophageal varices (EV). The data were reported in an oral presentation (Abstract #559) at the Digestive Disease Week® (DDW) 2007 conference, which took place in Washington, D.C. last week.
EV and portal hypertension (PHT) are two major complications of liver cirrhosis. EV are a serious consequence of PHT and are associated with a 20% rate of mortality. Current guidelines recommend endoscopic screening of patients with cirrhosis for EV. Those with no varices should undergo surveillance endoscopy every 2-3 years, while those with small varices at screening should undergo surveillance every 1-2 years.
"These recommendations represent a potentially large endoscopic burden, and their application is hampered by patient aversion to undergoing conventional EGD," said Roberto de Franchis, M.D., a lead clinical investigator on the study and Professor of Medicine at the University of Milan. "The availability of a less invasive screening test could improve patient acceptance of routine screening and thus increase adherence to the recommendations. The data reported today demonstrate that PillCam ESO meets the criteria for an effective, non-invasive screening test for EV in this patient population."
The international multi-center study presented was undertaken in 288 patients who were undergoing clinically indicated EGD for screening or surveillance of EV. Data show that the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for PillCam ESO compared with EGD was 84%, 88%, 92% and 77%, respectively. There were four cases in which PillCam ESO did not detect EV that were considered medium/large on EGD; and EGD did not confirm two cases of medium EV seen by PillCam ESO. Overall agreement between the two methods in detecting EV was 85.8%, while overall agreement in grading EV was 79%. With respect to distinguishing medium-large varices from small-no varices, the sensitivity, specificity, PPV, and NPV for PillCam ESO compared with EGD were 78%, 96%, 87%, 92%, respectively. The overall agreement on treatment decisions based on EV size was 91%.
"The results of this international trial make it clear that PillCam ESO is a well tolerated and non-invasive method for detecting EV," said Dr. de Franchis. "The characteristics of PillCam ESO with respect to sensitivity, specificity, PPV, and NPV appear comparable to EGD. PillCam ESO has the added benefit of being a non-invasive, more patient-friendly procedure. We believe that this device should now be considered an alternative to EGD for EV screening and for surveillance in patients with known EV, especially in patients unable or unwilling to undergo conventional EGD."
About the Trial
Patients were eligible for the study if they were at least 18 years of age and had signs or symptoms of portal hypertension, without previous diagnosis of esophageal varices and were clinically indicated to undergo screening endoscopy for the detection of varices. Patients with a prior endoscopic diagnosis of esophageal varices and indication for surveillance endoscopy also were eligible to participate. A total of 288 patients participated in the study, 195 for initial screening and 93 for surveillance. Patients underwent EGD within 48 hours after PillCam ESO. One patient was excluded because of vomiting the capsule prior to video capture of the distal esophagus. In another case, the capsule remained in the esophagus near the Z-line for about 25 minutes and was safely removed by the subsequent EGD. There were no other complications or capsule retention in this study. Although the endoscopist was not blinded to patient history or findings, a second investigator blinded to the EGD study read each PillCam ESO study.
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 took place May 19-24, 2007, at the Washington Convention Center, Washington, D.C. 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 www.ddw.org.
About Ethicon Endo-Surgery, Inc.
Ethicon Endo-Surgery, Inc. develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information on the company can be found at www.ethiconendo.com
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are underway in Europe and the U.S. A capsule to visualize the stomach is under development. More than 500,000 patients worldwide have benefited from the PillCam Capsule Endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit http://www.givenimaging.com.
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) satisfactory results of clinical trials with PillCam Colon (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 future litigation, including patent litigation with Olympus Corporation, (8) the reimbursement policies for our product from healthcare payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) 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, 2005. 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.
Source: Given Imaging
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