-- More than 1 in 4 patients with a negative pH catheter study had
pathological acid exposure during a 48-hour period of wireless pH
monitoring.
-- Nearly 1 in 2 patients had at least one day of pathological exposure
during a 96-hour period of wireless pH monitoring (total, upright or
supine).
-- Prolonged monitoring also increased the number of patients with a
significant association between reflux episodes and symptoms.
-- Follow-up showed that 6 of 7 patients with positive findings (acid
exposure or symptom association) did well after anti-reflux surgery;
whereas 6 of 7 patients with entirely negative findings failed to respond
to medical therapy.
Researchers indicated that it is unclear as to whether average pH
measurement or the single-worst-day measurement is more clinically
relevant, noting that either approach increased the diagnostic yield in
this study.
About the Bravo pH Monitoring System
The catheter-free Bravo pH Monitoring System has improved pH testing by
using a capsule that collects pH data and transmits it via radio frequency
telemetry to a small, external, pager-sized receiver worn by the patient.
Like catheter-based pH tests, the Bravo pH Monitoring System is an
ambulatory method of pH monitoring, regarded as a gold standard because it
improves the collection of data by measuring pH in the normal daily routine
to assess if the patient has GERD.
The Bravo system allows patients to maintain their regular diet and
activities. The Bravo system also minimizes throat and nasal discomfort
associated with conventional catheter-based pH systems, and, with little
visible indication that a pH test is taking place, Bravo pH monitoring
eliminates the social embarrassment that accompanies traditional pH
testing. By extending pH data collection to 48 hours, 24 hours beyond the
recording capability of conventional catheter systems, Bravo provides the
physician with additional data needed for an accurate GERD assessment. The
current study shows that Bravo increases the likelihood of GERD diagnosis
based on acid exposure and confirms that prolonged 48-hour monitoring
facilitates the documentation of relationships between symptoms and reflux
events, as reported first in a 2003 study published in The American Journal
of Gastroenterology(1). The Bravo system is the subject of more than 50
peer-reviewed and industry publications.
Traditional pH testing studies, sometimes combined with impedance
measurement, involve inserting a very small catheter into the nostril and
advancing it into the esophagus. Patients using the catheter method often
do not follow their usual daily schedule so the pH measurements may not be
predictive of GERD in the 24-hour testing period. Challenges to traditional
catheter based pH testing include throat irritation, difficulty sleeping
and discomfort during eating or drinking.
About GERD
Gastroesophageal reflux (also known as heartburn) occurs when contents from
the stomach flow back up into the esophagus. Occasional heartburn is
normal, but chronic heartburn caused by GERD can affect daily activities
and damage the esophagus. Left untreated, GERD may also lead to more
serious medical problems:
-- Difficulty swallowing (dysphagia)
-- Painful swallowing (odynophagia)
-- Narrowing of the esophagus (strictures)
-- Barrett's esophagus (pre-cancerous lesion)
-- Chronic hoarseness or laryngitis
-- Respiratory problems (coughing, asthma)
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 [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 diseases 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) Am J Gastroenterol 2003;98(4):740-749.
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-866-GIVEN-IR /