Healthcare Industry News:  Barrett's esophagus 

Devices Monitoring Gastroenterology

 News Release - June 1, 2009

Study Confirms Given Imaging's Bravo(R) pH Monitoring System to Be a Very Effective Diagnostic Tool for Assessing GERD

CHICAGO, IL--(Healthcare Sales & Marketing Network)--Jun 1, 2009 -- Given Imaging Ltd. (NasdaqGM:GIVN ) today announced the results of a study confirming that the Bravo pH Monitoring system delivered a definitive GERD diagnosis in patients for whom previously administered catheter-based pH monitoring tests proved inconclusive. Led by Rami Sweis, of the Oesophageal Laboratory, Guy's and St. Thomas' Hospital in London, the study (S1892) was presented during the annual Digestive Disease Week® (DDW) 2009 conference taking place in Chicago from May 30 - June 4.

"Had it not been for Bravo, many patients in this study would not have received a GERD diagnosis," said Dr. Mark Fox, Consultant Gastroenterologist at the University Hospital of Zürich. "Wireless monitoring improves several issues presented by traditional tests, including tolerability, its effect upon daily activities and patient compliance and the high day-to-day variability of esophageal acid exposure. Greater tolerability allows us to expand the duration and quantity of pH level data that we collect. The additional data enables us to definitively rule out or confirm acid reflux as a cause of symptoms and disease."

The study enrolled 23 consecutive patients who had symptoms suggestive of reflux but who previously had shown normal acid exposure and negative symptom association when evaluated with traditional, catheter-based pH monitoring systems. Researchers used standard esophageal acid measurements to analyze total reflux, upright reflux and supine reflux. Acid exposure over 24 hours was the primary outcome of the study. Key findings included:

-- More than 1 in 4 patients with a negative pH catheter study had pathological acid exposure during a 48-hour period of wireless pH monitoring.

-- Nearly 1 in 2 patients had at least one day of pathological exposure during a 96-hour period of wireless pH monitoring (total, upright or supine).

-- Prolonged monitoring also increased the number of patients with a significant association between reflux episodes and symptoms.

-- Follow-up showed that 6 of 7 patients with positive findings (acid exposure or symptom association) did well after anti-reflux surgery; whereas 6 of 7 patients with entirely negative findings failed to respond to medical therapy.

Researchers indicated that it is unclear as to whether average pH measurement or the single-worst-day measurement is more clinically relevant, noting that either approach increased the diagnostic yield in this study.

About the Bravo pH Monitoring System

The catheter-free Bravo pH Monitoring System has improved pH testing by using a capsule that collects pH data and transmits it via radio frequency telemetry to a small, external, pager-sized receiver worn by the patient. Like catheter-based pH tests, the Bravo pH Monitoring System is an ambulatory method of pH monitoring, regarded as a gold standard because it improves the collection of data by measuring pH in the normal daily routine to assess if the patient has GERD.

The Bravo system allows patients to maintain their regular diet and activities. The Bravo system also minimizes throat and nasal discomfort associated with conventional catheter-based pH systems, and, with little visible indication that a pH test is taking place, Bravo pH monitoring eliminates the social embarrassment that accompanies traditional pH testing. By extending pH data collection to 48 hours, 24 hours beyond the recording capability of conventional catheter systems, Bravo provides the physician with additional data needed for an accurate GERD assessment. The current study shows that Bravo increases the likelihood of GERD diagnosis based on acid exposure and confirms that prolonged 48-hour monitoring facilitates the documentation of relationships between symptoms and reflux events, as reported first in a 2003 study published in The American Journal of Gastroenterology(1). The Bravo system is the subject of more than 50 peer-reviewed and industry publications.

Traditional pH testing studies, sometimes combined with impedance measurement, involve inserting a very small catheter into the nostril and advancing it into the esophagus. Patients using the catheter method often do not follow their usual daily schedule so the pH measurements may not be predictive of GERD in the 24-hour testing period. Challenges to traditional catheter based pH testing include throat irritation, difficulty sleeping and discomfort during eating or drinking.

About GERD

Gastroesophageal reflux (also known as heartburn) occurs when contents from the stomach flow back up into the esophagus. Occasional heartburn is normal, but chronic heartburn caused by GERD can affect daily activities and damage the esophagus. Left untreated, GERD may also lead to more serious medical problems:

-- Difficulty swallowing (dysphagia)
-- Painful swallowing (odynophagia)
-- Narrowing of the esophagus (strictures)
-- Barrett's esophagus (pre-cancerous lesion)
-- Chronic hoarseness or laryngitis
-- Respiratory problems (coughing, asthma)

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 30 - June 4, 2009, at the McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

About Given Imaging Ltd.

Since 2001 Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam capsule endoscopy provides physicians with natural images of the small intestine via PillCam SB, the esophagus through PillCam ESO and the colon with PillCam COLON [not cleared for use in the USA]. The PillCam capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile(TM) 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). Given Imaging's products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to better diagnose diseases of the esophagus, small bowel and colon [PillCam COLON is not cleared for use in the USA.] and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. 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 Singapore. For more information, please visit http://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 "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 receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of significant litigation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, (11) the impact of global economic conditions, and (12) 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, 2008. 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) Am J Gastroenterol 2003;98(4):740-749.


Source: Given Imaging

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