- Cost analysis shows PillCam ESO saves more than
$10,000 versus a scoring-based risk stratification strategy for
patients at low risk -
- PillCam ESO is significantly more effective
than nasogastric tubes in detecting upper GI bleeding and
comparable to EGD in identifying upper GI ulcerations -
Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced results
from two studies highlighting the clinical and economic benefits of
PillCam ESO in the evaluation of patients with acute upper
gastrointestinal (GI) bleeding in the emergency department setting.
Both studies were presented during the American College of
Emergency Physicians (ACEP) Scientific Assembly, the largest annual
international emergency medicine conference, which took place in
Seattle, Washington, October 14-17, 2013.
"The Cost-Effectiveness Analysis of Video Capsule
Endoscopy Compared to Other Strategies to Manage Acute Upper
Gastrointestinal Hemorrhage in the Emergency Department"
(poster 65), presented by Andrew Meltzer, M.D., George Washington
University Medical Center, Washington, DC and colleagues, analyzed
the cost variances among diagnostic strategies including PillCam
capsule endoscopy, risk stratification using the Glasgow-Blatchford
score, nasogastric tube placement and an admit-all strategy. They
found that, for patients at low risk of requiring endoscopic
hemostatic intervention, capsule endoscopy was the dominant
strategy with a cost of $5,691. These metrics were significantly
stronger than all of the remaining strategies including the
nasogastric tube strategy with added incremental cost of $2,469,
the risk stratification strategy with an incremental cost of
$10,695 and the admit-all strategy with an incremental cost of
$17,076 versus capsule endoscopy. For moderate risk patients,
capsule dominated an admit-all strategy with a cost of $9,190
versus an added incremental admit-all cost of $13,098. Based on
this analysis, researchers concluded that capsule endoscopy may be
cost-effective for low and moderate risk patients presenting with
upper GI bleeding to the emergency department.
Although the risk stratification strategy utilizing the
Glasgow-Blatchford score is recommended, neither this strategy nor
the nasogastric tube are utilized by most emergency departments. A
2012 National Institute of Health funded study found that one in
every five Americans has at least one visit to the emergency
department per year1, with a large number of patients depending on
the emergency department to obtain acute medical care, resulting in
increased healthcare costs.
"PillCam's unique ability to directly visualize the upper GI
tract non-invasively to identify the presence or absence of a
hemorrhage could offer a novel and cost-effective approach in the
emergency department setting," said Dr. Meltzer. "The cost savings
on a per-patient basis could have a positive impact on the economic
outcomes health care systems are striving for today."
"Capsule Endoscopy In Acute Upper Gastrointestinal
Hemorrhage: A Prospective Cohort Study", from Ian Gralnek,
M.D., Department of Gastroenterology, Rambam Health Care Campus,
Haifa, Israel, and colleagues, compared PillCam ESO to nasogastric
tube in determining the presence of blood in emergency department
patients with suspected upper GI bleeding. PillCam ESO was also
compared to esophagogastroduodenoscopy (EGD) in determining the
source of bleeding and the presence of inflammatory lesions. After
fully conducting all three exams, blood was detected in the upper
GI tract in 83.3% of patients by PillCam ESO and in only 33.3% of
patients by nasogastric tubes (p=0.035). In identifying
inflammatory lesions, PillCam ESO had similar findings compared to
EGD. Based on these results, the researchers concluded that PillCam
ESO is a feasible and safe exam to facilitate patient triage and
earlier endoscopy.
About PillCam ESO
The PillCam ESO video capsule was cleared by the U.S. Food and
Drug Administration in patients 18 years and older to visualize the
esophagus. PillCam ESO contains imaging devices and light sources
at both ends of the capsule to capture 18 images per second as it
passes down the esophagus in a patient-friendly thirty-minute
procedure.
The risks of PillCam capsule endoscopy include capsule
retention, aspiration and skin irritation. After ingesting the
PillCam capsule and until it is excreted, patients should not be
near any source of powerful electromagnetic fields, such as one
created by an MRI device. Endoscopic placement may present
additional risks. Medical, endoscopic or surgical intervention may
be necessary to address these complications, should they occur.
Please consult the product user manual or refer to givenimaging.com
for detailed information.
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 monitoring, and SmartPill®
motility 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
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. 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 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, 2012. 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.
1 National Center for Health Statistics (2006) Health: United
States, 2006, With Chartbook on Trends in the Health of Americans.
Hyattsville, MD: NCHS.
CONTACT: For further information contact:
Chantal Beaudry/Martyna Gawrych
Lazar Partners Ltd.
cbeaudry@lazarpartners.com
mgawrych@lazarpartners.com
212-867-1762
Investor Contact:
David Carey
Lazar Partners Ltd.
dcarey@lazarpartners.com
212-867-1762
Israel Investor Contact:
Nava Ladin
Gelbart Kahana Investor Relations
+972-3-6074717
nava@gk-biz.com
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