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Data Show That Capsule Endoscopy Correlates With Gastroscopy Findings; Study Shows That Bravo pH Monitoring Can Be Successfully Extended in Most Cases

Sun, 05/20/2012 - 9:45am
The Associated Press

(http://www.givenimaging.com)

Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products

and pioneer of capsule endoscopy, today announced that new studies

confirm the value of its PillCam@ ESO as a tool to help triage

patients with upper gastrointestinal bleeding (UGIB) and show that

PillCam ESO can detect lesions that traditional gastroscopy has

missed.

An additional new study shows that Bravo@ pH monitoring for patients

with gastroesophageal reflux disease (GERD) can be extended to four

days to increase findings. This longer duration will result in more

meaningful feedback regarding patients' conditions and how they are

affected by daily activities, allowing doctors to work with patients

to adjust their diet and drug regimens. The data from these studies

were presented at Digestive Disease Week@ (DDW), being held from May

19-22, 2012, in San Diego.

"These new studies confirm the clinical efficacy of PillCam ESO and

Bravo pH monitoring in diagnosing, monitoring, and triaging a variety

of esophageal disorders," said David Mason, MD, Chief Medical Officer

at Given Imaging. "PillCam ESO has been shown to be useful in

detecting lesions which if not quickly found could result in serious

or fatal bleeding in the upper GI tract and in detecting lesions that

gastroscopy was not able to pick up. Additionally, Bravo pH monitoring

helped to successfully monitor and stratify cases of gastroesophageal

reflux disease (GERD)."

Three key poster presentations were presented on PillCam ESO and Bravo

pH monitoring:

Additional studies were presented that used Given Imaging's manometry

and reflux products:

About the Bravo@ pH Monitoring SystemThe Bravo@ pH monitoring system

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 PillCam@ ESOThe PillCam@ ESO video capsule was cleared by the

U.S. Food and Drug Administration in patients eighteen years and older

to visualize the esophagus. Now in its third generation, PillCam ESO 3

contains imaging devices and light sources at both ends of the capsule

to capture 35 images per second as it passes down the esophagus in a

patient-friendly thirty-minute procedure.

All medical procedures carry some risks. The risks of PillCam capsule

endoscopy include capsule retention, aspiration, or skin irritation.

The risks of the PillCam patency capsule include capsule retention and

aspiration. 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 any

of these complications, should they occur.

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@ pH and

Digitrapper@ pH and impedance monitoring. 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(http://ctt.marketwire.com/?release=889650&id=1628134&type=1&url=http%3a%2f%2fwww.givenimaging.com%2f).

About Digestive Disease Week@DDW is the largest international

gathering of physicians, researchers and academics in the fields of

gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

Jointly sponsored by the American Association for the Study of Liver

Diseases, the American Gastroenterological Association (AGA)

Institute, the American Society for Gastrointestinal Endoscopy and the

Society for Surgery of the Alimentary Tract, DDW takes place May 19 -

22, 2012, at the San Diego Convention Center. The meeting showcases

more than 5,000 abstracts and hundreds of lectures on the latest

advances in GI research, medicine and technology. For more

information, visit

www.ddw.org(http://ctt.marketwire.com/?release=889650&id=1628137&type=1&url=http%3a%2f%2fwww.ddw.org%2f).

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) 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 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) National Institute of Diabetes and Digestive and Kidney Diseases

(niddk.nih.gov)

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