Given Imaging (Nasdaq:GIVN), a world leader in GI medical devices
and pioneer of capsule endoscopy, today announced results from
multiple studies that showed the positive impact of ManoScan® high
resolution manometry and Bravo® pH monitoring in measuring
esophageal dysfunction and the severity of symptoms including
dysphagia, chest pain and reflux. The studies were presented during
the American College of Gastroenterology's 2013 Annual Scientific
Meeting (ACG), taking place October 11-16, 2013 in San Diego,
California where Given Imaging is exhibiting at booth #1200
throughout the conference.
Highlights of key studies presented at ACG include:
- Repeat esophageal manometry positively impacts diagnostic
management in 57.6% of patients
- ManoScan provides valuable insights about opioid induced
esophageal dysfunction, a condition for which limited data was
previously available
- High resolution manometry finds a higher rate of achalasia in
African American women as compared to other races/ethnicities in
the largest multi-ethnic cohort evaluated to date
- Bravo pH monitoring helps redirect care in 95% of patients with
esophageal symptoms who didn't respond to high dose PPI
therapy
"Determining the correspondence between esophageal disorders and
their underlying causes can be difficult due to the overlapping
symptoms of many gastrointestinal conditions," said John
Pandolfino, M.D., Chief, Division of Medicine-Gastroenterology and
Hepatology, Northwestern University Feinberg School of Medicine.
"Using ManoScan high resolution manometry and Bravo pH monitoring,
we can now pinpoint the underlying causes of a patient's symptoms,
determine a patient's condition, and tailor therapies to ultimately
improve patient outcomes."
Dr. John Pandolfino and colleagues at Northwestern University,
presented poster #P29, "The Natural History of
Esophagogastric Junction Outflow Obstruction and Treatment
Outcomes," and discussed how patients with this condition,
as diagnosed by high resolution manometry, present with dysphagia
as the predominant symptom (46%), followed by chest pain (32%),
heartburn (20%), or nausea and vomiting (19%). More patients
reported improvement in symptoms with treatment, but additional
prospective studies are needed to evaluate the effect of different
treatment modalities on patient outcomes.
In addition, high resolution manometry was also evaluated in
specific patient sub-populations including the elderly and chronic
opioid users. In poster #P1216, "Alterations in Esophageal
Function on High Resolution Esophageal Manometry in the
Elderly," Steven DeMeester M.D., and colleagues at the
Keck School of Medicine of the University of Southern California
performed an analysis of 164 patients who underwent high resolution
manometry and found that abnormal peristaltic breaks were observed
in more patients over 70 years of age (44% vs. 10%) and were more
common in patients with GERD and dysphagia symptoms. The authors
noted that the decline in esophageal body function with age did not
appear to be related to the severity of GERD and should be
considered when discussing treatment options and expected outcomes
in patients 70 years or older.
To further validate the high resolution manometry's clinical
utility, in poster #P24, "The Utility of Repeat Esophageal
Manometry," Brian Lacy M.D., and colleagues at
Dartmouth-Hitchcock presented a retrospective review of 132
patients who underwent at least two consecutive esophageal
manometry tests. The team found value in repeat testing, noting it
led to a change in diagnosis in 57.6% of patients. A higher rate of
new diagnosis (67%) was also found in patients who presented with a
change of indication between their first and second test and the
authors concluded that repeating esophageal manometry should be
considered if symptoms of dysphagia or chest pain persist or if
symptoms change over time. In poster #P611, "Opioid Induced
Esophageal Dysfunction (OIED) in Chronic Opioid Users,"
Shiva Ratuapli M.D. and colleagues from Mayo Clinic Arizona
evaluated the impact of opioid use on bowel dysfunction and
motility. A retrospective review of the motility database
identified 123 chronic opioid users, with 67 patients reporting
being current users and 56 patients reporting no opioid use in the
prior 24 hours. Investigators used ManoScan high resolution
manometry and conducted an analysis with ManoView software 3.0. The
Chicago classification system, the industry's standardized
categorization scheme for identification of motility disorders, was
used to characterize esophageal dysmotility. The study found that
opioid induced esophageal dysfunction was present in both chronic
and current opioid users and that patients taking opioids within 24
hours of manometry exhibited more frequent outflow obstruction and
spastic dysmotility patterns compared with those who stopped opioid
use for at least 24 hours prior to the study.
Poster #P613, "Effect of Race and Ethnicity on the
Clinical Presentation, Treatment Decisions and Treatment Outcomes
for Patients with Achalasia Defined by the Chicago
Classification," presented by Elizabeth Rosenblatt M.D.,
and colleagues from Johns Hopkins, conducted a retrospective review
of 1,268 patients that utilized the Chicago Classification of
Esophageal Motility and high resolution manometry to meaningfully
subgroup patients with achalasia. In this largest known cohort
assembled to address racial and ethnic disparities in the use of
high resolution manometry and manometric standards, the researchers
found that a higher percentage of women presented with achalasia in
African Americans as compared to other race/ethnicity groups. They
also found that treatment decisions and outcomes were similar
across all groups.
In looking at the impact of pH monitoring in evaluating
esophageal symptoms both on and off PPI therapy, "Four-Day
Two-Phase Wireless pH Monitoring for Evaluation of Esophageal
Symptoms Refractory to High Dose PPI: Utility in Clinical
Practice", poster #P14 was presented by Louis Wilson,
M.D., Wichita Falls Gastroenterology Associates, Wichita Falls,
Tex. Forty-two patients with esophageal symptoms who were not
responding to high dose PPI therapy underwent Bravo pH monitoring
for up to 88 hours. Results for pH monitoring contributed to
redirecting care in 95% of patients, including eliminating PPI use
in 15 patients and delivering new diagnoses in 12 patients. Bravo
pH monitoring successfully identified GERD in 32 patients.
About ManoScan high resolution manometry
Given Imaging pioneered ManoScan high resolution manometry, the
first high resolution manometry system. ManoScan system continues
to remain the market leader in comprehensive solutions for
assessing gastrointestinal motility. ManoScan is the only system
with automatic findings incorporated into the Chicago
Classification algorithms, a standardized categorization system for
identifying and classifying motility disorders. 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.
Manometry products have certain risks associated with catheter
insertion. Medical, endoscopic or surgical intervention may be
necessary to address complications, should they occur. These
systems are not compatible for use in an MRI magnetic field.
About Bravo pH monitoring
Bravo pH monitoring is the only catheter-free pH test. The
procedure uses a pH capsule that is temporarily attached to the
wall of the esophagus to wirelessly transmit pH data continuously
for up to 96 hours. 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 risks of Bravo pH monitoring include: premature detachment,
discomfort, failure to detach, failure to attach, capsule
aspiration, capsule retention, tears in the mucosa, bleeding, and
perforation. Endoscopic placement may present additional risks.
Medical, endoscopic, or surgical intervention may be necessary to
address any of these complications, should they occur. Because the
capsule contains a small magnet, patients should not have an MRI
study within 30 days of undergoing the Bravo pH test.
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.
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
Given Imaging (NASDAQ:GIVN)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Given Imaging (NASDAQ:GIVN)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024