Given Imaging Announces New Studies Highlighting Diverse Applications of ManoScan(TM) High Resolution Manometry
October 22 2012 - 8:01AM
Marketwired
Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced data from
numerous studies highlighting the value of ManoScan™ high
resolution manometry in assessing esophageal and anorectal muscle
function. The studies are being presented at the American College
of Gastroenterology 2012 annual meeting taking place in Las Vegas
from October 19-24, 2012. Given Imaging is exhibiting at booth
#1325 throughout the conference.
Poster presentations about high resolution esophageal manometry
include:
- "Esophageal Dysmotility Increases with the
Severity of Gastroesophageal Reflux Disease: A Study Using High
Resolution Manometry and the Revised Chicago Classification
Criteria," (P9) by
Stephen Ou, MD, University of California-Irvine Medical Center,
Orange, CA and colleagues, retrospectively reviewed 150 cases
in which high resolution manometry was performed on patients
presenting with GERD symptoms. Researchers from the University of
California-Irvine Medical Center applied the revised Chicago
Classification criteria to each previously performed case to
determine the prevalence of dysmotility among the patients. The
researchers concluded that esophageal dysmotility, characterized by
the new Chicago Classification criteria, increases with the
severity of esophageal acid exposure.
- "High Resolution Manometry Metrics in the
Upright Position: A Validation Study," (P579)
by Andrew Read, MD, Northwestern University Feinberg School of
Medicine, Chicago, IL and colleagues, found that normative
ranges for high resolution manometry metrics decreased
significantly when the test was performed in the upright position
compared with the supine position. Researchers from the Department
of Medicine, Northwestern University Feinberg School of Medicine,
compared high resolution manometry metrics including integrated
relaxation pressure, distal contractile integral, contractile front
velocity and distal latency in tests conducted in the upright or
supine position. Due to the significant decreased normative range
of the metrics in the upright position, researchers suggested that
the cut-off values for abnormal function should be adjusted if high
resolution manometry is performed in the upright position.
- "A Study of Interobserver Agreement with High
Resolution Esophageal Pressure Topography and Impedance Manometry,"
(P582) by Erick R. Singh, MD, Georgia Health Sciences University,
Augusta, GA and colleagues, used high resolution impedance and
high resolution manometry testing to assess bolus transit and
identify esophageal contraction patterns to give a more complete
study of esophageal function. Researchers from the Division of
Gastroenterology, Georgia Health Sciences University, found an
incremental benefit in diagnosing esophageal dysfunction with the
addition of high resolution impedance to high resolution
manometry.
Poster presentations about high resolution anorectal manometry
include:
- "High Resolution Anal Pressure Topography in
Chronic Constipation and Healthy Asymptomatic Volunteers,"
(P1565) by Vanessa Costilla, MD, Mayo Clinic
Arizona, Scottsdale, AZ, and colleagues, presented data from
one of the first studies to use high resolution anorectal manometry
to compare the anorectal pressure measures of chronic constipation
patients with healthy, asymptomatic patients. Researchers from Mayo
Clinic Arizona and Dartmouth-Hitchcock Medical Center completed 2-D
HRM using ManoScan to find that patients with chronic constipation
had significantly lower anorectal resting pressure, initial squeeze
pressure, terminal squeeze pressure, squeeze fatigue rate and anal
canal length compared with the healthy patient group. Chronic
constipation patients also demonstrated a significantly higher urge
to defecate and increased balloon expulsion time compared with the
healthy patient group. The researchers concluded that anorectal
high resolution manometry facilitates the evaluation of anorectal
dynamics.
"As we continue to learn about the clinical value of ManoScan
high resolution manometry through studies such as those presented
at this conference, it is clear that it provides us with important
new information about esophageal pressure and motor function as
well as anorectal function that can help us more effectively treat
GI diseases," said John Pandolfino, MD, Northwestern Memorial
Hospital, Chicago, IL. "This technology provides physicians with
valuable information that could potentially help correlate patient
symptoms with measurements of esophageal and anorectal
function."
About ACG The American College of
Gastroenterology is a recognized leader in educating GI
professionals and the general public about digestive disorders.
Their mission is to serve the evolving needs of physicians in the
delivery of high quality scientific, humanistic and cost-effective
health care to gastroenterology patients. For more information,
visit http://gi.org.
About ManoScan™ High Resolution Manometry
ManoScan high resolution manometry 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.
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® capsule endoscope for the small bowel,
esophagus and colon. The company also offers industry-leading GI
functional diagnostic solutions including ManoScan™ high-resolution
manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z
impedance, and the SmartPill® GI monitoring systems. 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, Hong Kong and Brazil. 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
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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. Such
forward-looking statements include statements relating to the
Company exploring strategic alternatives and considering possible
strategic transactions involving the Company. 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 ability of the Company to
reach agreement on any strategic alternative and/or to complete any
such alternative, as well as 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) quality
issues and adverse events related to our products, such as capsule
retention, aspiration and failure to attach or detach, bleeding or
perforation that could require us to recall products and impact our
sales and net income, 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, 2011. 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 to the
extent expressly required under applicable law, the Company
undertakes no obligation to release publicly any revisions to any
forward-looking statements, to report events or to report the
occurrence of unanticipated events.
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 1-212-867-1762 flazar@lazarpartners.com
dcarey@lazarpartners.com Israel Investor Contact: Nava Ladin
Gelbart Kahana Investor Relations +972-3-6074717
nava@gk-biz.com
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