-- 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 www.ddw.org.
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™
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 http://www.givenimaging.com.
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
Hypertension.et 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.
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-866-GIVEN-IR /