New Data Support PillCam(R) ESO as a Non-Invasive Alternative to Upper Endoscopy for Detection of Esophageal Varices
Demonstrated Utility in Screening and Surveillance of Esophageal Varices
YOQNEAM, ISRAEL, and CHICAGO, IL--(Marketwire - May 31, 2007) - Given Imaging Ltd.
(NASDAQ: 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™ 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.
Contact Information: For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
1-(866) GIVEN-IR
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