Given Imaging's SensorBelt Available to More Patients
February 22 2011 - 7:00AM
Marketwired
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI
products and pioneer of capsule endoscopy, today announced that the
U.S. Food and Drug Administration (FDA) has cleared revised
labeling regarding the use of the SensorBelt in patients with a
Body Mass Index (BMI) of up to 43.3 kg/m2, reflecting the results
of a recent clinical trial. The SensorBelt is a convenient,
easy-to-use alternative to placing an array of sensors on a
patient's abdomen during a PillCam capsule endoscopy procedure.
"The SensorBelt has been an important addition to our capsule
endoscopy procedure, reducing time required to prepare patients for
the procedure, improving workflow and enhancing the patient
experience," said Deena Stewart, RN, CGRN, BSN, King's Daughters
Medical Center, Ashland, KY. "With this clearance, we can now offer
more patients an easy-to-use, patient-friendly alternative during
their PillCam SB capsule endoscopy procedure and continue to
streamline and save valuable time for their care teams."
Introduced in 2009, the SensorBelt is fitted over a single layer
of natural fiber clothing worn by the patient and employs
easy-fasten straps for quick adjustments and removal. The sensors
are incorporated within the belt and eliminate the need for a nurse
to adhere sensors or prepare a patient's abdomen for the
procedure.
About PillCam SB
The PillCam® SB video capsule measures 11 mm x 26 mm and weighs
less than four grams. Now in its second generation, PillCam SB 2
contains an imaging device and light source and transmits images at
a rate of two images per second generating more than 50,000
pictures during the course of the procedure. Initially cleared by
the U.S. Food and Drug Administration in 2001, PillCam SB is
clinically validated by more than 1,200 peer-reviewed studies. It
is an accurate, patient-friendly tool used in patients two years
and older by physicians to visualize the small bowel. PillCam SB is
the gold standard in small bowel evaluation.
The risks of PillCam® capsule endoscopy include capsule
retention, aspiration, or skin irritation. The risks of the Agile™
GI patency test include capsule retention and aspiration.
Endoscopic placement may present additional risks. Medical,
endoscopic, or surgical intervention may be necessary to address
any of these complications, should they occur.
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal
visualization by developing state-of-the art, patient-friendly
tools based on its PillCam® Platform. PillCam® capsule endoscopy
uses wireless technology and advanced software to provide
physicians with clear images of the small intestine via PillCam® SB
and the esophagus through PillCam® ESO. The PillCam® COLON, which
is an investigational device in the U.S., is designed to visualize
the colon. The PillCam® capsules are miniature video cameras that
patients ingest. Given Imaging's other capsule products include
Agile™ patency capsule, to verify intestinal patency, and Bravo® ,
the only wireless, catheter-free, 48-hour pH test commercially
available for pH testing to assess gastroesophageal reflux disease
(GERD). In April, 2010, Given Imaging acquired Sierra Scientific
Instruments, the leading provider of specialty GI diagnostic
solutions and pioneer of high-resolution manometry for assessing
gastrointestinal motility. Sierra Scientific is now a wholly-owned
subsidiary of Given Imaging. Given Imaging's headquarters,
manufacturing and R&D facilities are located in Yoqneam,
Israel, with operating subsidiaries in the United States, Germany,
France, Japan, Australia, 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
"will," "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) the
availability of reimbursement or other forms of funding for our
products 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, and (18) 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, 2009. 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.
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 212-867-1768 Email Contact Email Contact
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