Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced the
results of two new studies indicating that physicians should
analyze pH levels of patients with gastroesophageal reflux disease
(GERD) for periods of 48 hours or longer to strengthen symptom
correlation and improve diagnostic accuracy. The Company also
announced the results of a study highlighting the unnecessary
continued use of proton pump inhibitors (PPIs) after negative
pH-impedance testing with Given Imaging's Digitrapper® pH-Z
Monitoring System. All four studies were presented at Digestive
Disease Week (DDW) 2011, in Chicago, McCormick Place, May 7-10.
"Reflux events and symptoms vary day-to-day and are greatly
affected by patient behavior, such as exercise and eating.
Therefore, it is often advisable to monitor GERD patients for at
least 48 hours to have an accurate understanding of the severity of
disease and the cause of their symptoms," said Mark Fox, Clinical
Associate Professor at the Nottingham Digestive Diseases Centre,
United Kingdom. "The longer we study these patients, the more
reliable and consistent data we are able to gather, enhancing our
ability to diagnose and manage their condition."
In Dr. Mark Fox's study, abstract Sa1181,
163 patients underwent a 96-hour Bravo recording, followed by an
evaluation of the measured acid exposure time, symptom index and
symptom association probability, at 24-hour intervals to determine
the measurement consistency of 96-hour ambulatory reflux
monitoring. The study authors concluded that increasing the
duration of reflux studies greatly improved the consistency of GERD
diagnosis based on pH monitoring. Dr. Fox also led a podium
presentation, abstract #499, on "Symptom Association in Ambulatory Gastro-Esophageal Reflux
Monitoring: A Systematic Review". Researchers analyzed data
recordings from the Bravo pH Monitoring System and corresponding
symptom diaries of the 163 patients using the authors' custom
written software. Their systematic analysis demonstrated that a
threshold for reflux detection of pH4.5 and a time window of 1
minute were optimal for reflux-symptom association. Another study,
abstract Sa1199, compared 48-hour Bravo
recordings with 24-hour catheter-based recordings and scores at day
one vs. day two vs. total in a retrospective chart review of 124
patients. The researchers concluded that 48-hour pH monitoring
strengthens symptom correlation as compared to 24-hour results.
Further, they suggested that 48-hour Bravo studies should be
performed as standard of practice.
Separately, an additional study, abstract
#497, looked at the correlation of pH-impedance (MII-pH)
results using Given Imaging's Digitrapper® pH-Z Monitoring System
and patient use of PPIs to manage their symptoms.
Jami Rothe, of the University of Chicago, led a podium
presentation on the results of abstract #497.
The study analyzed the results of a phone survey of 87 patients
whose MII-pH tests had ruled out GERD, and found that many had
continued PPI therapy. The researchers highlighted a correlation
between patients who continue PPI therapy without a definitive GERD
diagnosis and an increase in the likelihood to have symptoms of
anxiety or pain. The study authors emphasized the need for improved
strategies to better identify the cause of patient symptoms as well
as alternative treatment options for patients who do not experience
symptom relief from PPIs.
About GERD Gastroesophageal reflux (also
known as heartburn) occurs when contents from the stomach flow back
up into the esophagus. Occasional heartburn related to these events
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)
Symptoms of GERD can be seen in two to eight percent of children
aged three to nine years and in five percent of adolescents(1).
GERD symptoms in children are similar to those experienced by
adults, such as heartburn, acid regurgitation, excessive belching,
and dysphagia; however presentation may be less obvious with
abdominal pain and failure to thrive as the only sign of disease.
Gastroesophageal reflux disease in children and adolescents is
often managed through lifestyle changes, the introduction of
medications which decrease gastric acid, and in rare circumstances
surgery is needed.
About Digestive Disease Week Digestive
Disease Week (DDW) is the largest international gathering of
physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. DDW is 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. 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 the Bravo pH Monitoring System The
Bravo® pH Monitoring System is the only catheter-free pH test. The
procedure uses a capsule that collects and transmits pH data 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, considered the gold standard for pH measurement and
monitoring of gastric reflux. The Bravo pH Monitoring System
collects data that are more reflective of the patient's 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.
With little visible indication that a pH test is taking place,
Bravo pH monitoring eliminates the social embarrassment that
accompanies traditional pH testing. The Bravo pH Monitoring System
extends pH data collection to 48 hours or more than twice the
recording capability of conventional catheter systems. Bravo
provides physicians with additional data needed for an accurate
GERD assessment. Current studies show 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(2). 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 the insertion of a very small
catheter into the nostril and advancing it into the esophagus,
where it stays throughout the 24-hour testing period. Patients
using the catheter method often do not follow their usual daily
schedule so the pH measurements may not be predictive of GERD
during the 24-hour testing period. Challenges to traditional
catheter-based pH testing include throat irritation, difficulty
sleeping and discomfort during eating and drinking.
All medical procedures carry some risks. Bravo® pH monitoring
risks include: premature detachment, discomfort, failure to detach,
tears in the mucosa, bleeding, and perforation. Endoscopic or
transnasal placement may present additional risks. Medical,
endoscopic, or surgical intervention may be necessary to address
any of these complications, should they occur.
About the Digitrapper pH-Z Monitoring
System The Digitrapper® pH-Z Monitoring System includes
AccuView™ analysis software, which presents study data in a clear,
anatomically-oriented fashion and rapidly generates reports using
advanced analysis methods. The Digitrapper pH-Z recorder is
commonly recognized as the standard for ambulatory esophageal
24-hour pH monitoring and is used for catheter-based pH or
pH-impedance monitoring.
All medical procedures carry some risks. The risks of catheter
insertion into the nasal passage include: discomfort, nasal pain,
minor bleeding, runny nose, throat discomfort, irregular heartbeat
with dizziness, and perforation. In rare instances, the catheter
may be misdirected into the trachea causing coughing or choking, or
the catheter may shift up or down causing false results. Medical,
endoscopic, or surgical intervention may be necessary to address
any of these complications, should they occur. The system is not
compatible for use in an MRI magnetic field.
About Given Imaging Ltd. Since pioneering
the field of capsule endoscopy in 2001, Given Imaging has become a
world leader in GI medical devices, offering health care providers
a range of innovative options for visualizing, diagnosing and
monitoring the digestive system. The company offers a broad product
portfolio including PillCam® video capsules for the small bowel,
esophagus and colon [PillCam® COLON not approved for use in the
United States], industry-leading ManoScan™ high-resolution
manometry and Bravo® wireless and Digitrapper® pH and impedance
products. Given Imaging is committed to delivering breakthrough
innovations to the GI community and to supporting its ongoing
clinical needs. Given Imaging's headquarters are located in
Yoqneam, Israel, with operating subsidiaries in the United States,
Germany, France, Japan, Australia, Vietnam and Hong Kong. For more
information, please visit 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
successfully complete any necessary or required clinical studies
with our products, (3) our ability to receive regulatory clearance
or approval to market our products or changes in regulatory
environment, (4) our success in implementing our sales, marketing
and manufacturing plans, (5) the level of adoption of our products
by medical practitioners, (6) the emergence of other products that
may make our products obsolete, (7) lack of an appropriate bowel
preparation materials to be used with our PillCam COLON capsule,
(8) protection and validity of patents and other intellectual
property rights, (9) the impact of currency exchange rates, (10)
the effect of competition by other companies, (11) the outcome of
significant litigation, (12) our ability to obtain reimbursement
for our product from government and commercial payors, (13)
quarterly variations in operating results, (14) the possibility of
armed conflict or civil or military unrest in Israel, (15) the
impact of global economic conditions, (16) our ability to
successfully integrate acquired businesses, (17) changes and
reforms in applicable healthcare laws and regulations, (18) adverse
events related to our products or product quality issues that could
require us to recall products and impact our sales, and (19) 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, 2010. 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) Current Treatment Options in Gastroenterology 2007; 10:
391-400 (2) Am J Gastroenterol 2003;98
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 212 867 1768 flazar@lazarpartners.com
dcarey@lazarpartners.com
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