Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced two new
studies highlighting the value of ManoScan High Resolution
Manometry in determining the source of dysphagia in patients who
have undergone anti-reflux surgery. The studies were conducted at
the Hospital Clinico San Carlos in Madrid, Spain and presented at
the United European Gastroenterology Week (UEGW), Europe's largest
gastroenterology conference, being held in Stockholm, Sweden from
October 22nd through October 26th. Given Imaging is exhibiting at
booth A08:30 throughout the conference.
"The cause of dysphagia post-fundoplication has previously been
very difficult to determine and treat. Our data suggest that the
use of high resolution manometry in combination with traditional
diagnostic tests is extremely valuable," said Dr. Ruiz de Léon,
Hospital Clinico San Carlos, Madrid, Spain. "High resolution
manometry allows us to easily interpret radiological data and
provides us with additional information to identify the source of
dysphagia so we can appropriately treat our patients."
In a new study (abstract P0791),
researchers from the Hospital Clinico San Carlos evaluated the high
resolution manometry (HRM) findings of 30 patients with long-term
dysphagia after Nissen fundoplication. All patients underwent HRM,
barium x-ray, esophageal endoscopy and ambulatory pH monitoring,
and the results of the four tests were compared to look for
possible mechanisms of dysphagia post-surgery. The study authors
concluded high resolution manometry accurately located the lower
esophageal sphincter and esophagogastric junction allowing the
researchers to identify the source of dysphagia. In addition, HRM
was able to show dysfunctional fundoplication indicated by pressure
abnormalities at the gastric level and mechanism changes difficult
to diagnose by other modalities. Overall the authors found that HRM
complements the traditional techniques and makes interpretation of
clinical results easier.
Using the same patient population, the study authors compared
the clinical value of ManoScan High Resolution Manometry to
radiology, endoscopy, and pH monitoring in poster presentation,
P0792. The cause of dysphagia was identified
in 18 of 30 patients, in the remaining 12 patients, 10 cases of
probable but less specific causes for dysphagia were found, the
final two cases were inconclusive. The results of HRM testing
identified 21 patients with abnormal findings. The study authors
concluded that all four diagnostic tests are complementary for
dysphagia post-fundoplication. However, high resolution manometry
alone was superior to all other tests and one of the most useful
techniques for diagnosing post-Nissen dysphagia.
About Esophageal Dysphagia Dysphagia, also
known as difficulty swallowing, results from impeded transport of
liquids, solids, or both from the pharynx to the stomach.(1)
Although dysphagia can happen to anyone, it is most common in older
adults, premature babies, and people with problems of the brain or
nervous system.(2) Normally, the muscles in esophagus squeeze, or
contract, to move food and liquids from the mouth to the stomach
without problem. However when there is an obstruction in the
esophagus or the muscles and nerves that help move food through the
throat and esophagus are not working right patients can experience
difficulty or the inability to swallow. Dysphagia in adults may be
due to tumors, conditions that cause the esophagus to narrow,
neuromuscular conditions, stroke, GERD or when the muscles in the
esophagus do not relax enough to let food pass to the stomach.(3)
Other risk factors include smoking, excessive alcohol use, certain
medications, and teeth or dentures in poor condition. Treatment for
dysphagia can range from esophageal exercises, medication and in
severe cases surgery to clear or repair the esophagus.(4)
About ManoScan ESO ManoScan™ pioneered
solid state high resolution manometry (HRM) and remains the market
leader in comprehensive solutions for assessing gastrointestinal
motility. Through the combination of proprietary tactile-sensing
catheter technology and easy-to-use ManoView™ software, ManoScan
reveals complex functional anatomy, enabling physicians to more
accurately diagnose abnormalities of the gastrointestinal
tract.
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 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) 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) Merck Manual. Dysphagia.
http://www.merckmanuals.com/professional/gastrointestinal_disorders/esophageal_and_swallowing_disorders/dysphagia.html
(2) WebMD.
http://www.webmd.com/digestive-disorders/tc/difficulty-swallowing-dysphagia-overview
(3) University of Maryland Medical Center.
http://www.umm.edu/altmed/articles/dysphagia-000053.htm (4) Mayo
Clinic.
http://www.mayoclinic.com/health/difficulty-swallowing/DS00523/DSECTION=treatments-and-drugs
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 1-212-867-1768 flazar@lazarpartners.com
dcarey@lazarpartners.com
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