Given Imaging Ltd. Announces New Studies Highlighting Diverse Applications of ManoScan High Resolution Manometry
Published: Oct 22, 2012
LAS VEGAS, NV--(Marketwire - October 22, 2012) - Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced data from numerous studies highlighting the value of ManoScan™ high resolution manometry in assessing esophageal and anorectal muscle function. The studies are being presented at the American College of Gastroenterology 2012 annual meeting taking place in Las Vegas from October 19-24, 2012. Given Imaging is exhibiting at booth #1325 throughout the conference.
Poster presentations about high resolution esophageal manometry include:
- "Esophageal Dysmotility Increases with the Severity of Gastroesophageal Reflux Disease: A Study Using High Resolution Manometry and the Revised Chicago Classification Criteria," (P9) by Stephen Ou, MD, University of California-Irvine Medical Center, Orange, CA and colleagues, retrospectively reviewed 150 cases in which high resolution manometry was performed on patients presenting with GERD symptoms. Researchers from the University of California-Irvine Medical Center applied the revised Chicago Classification criteria to each previously performed case to determine the prevalence of dysmotility among the patients. The researchers concluded that esophageal dysmotility, characterized by the new Chicago Classification criteria, increases with the severity of esophageal acid exposure.
- "High Resolution Manometry Metrics in the Upright Position: A Validation Study," (P579) by Andrew Read, MD, Northwestern University Feinberg School of Medicine, Chicago, IL and colleagues, found that normative ranges for high resolution manometry metrics decreased significantly when the test was performed in the upright position compared with the supine position. Researchers from the Department of Medicine, Northwestern University Feinberg School of Medicine, compared high resolution manometry metrics including integrated relaxation pressure, distal contractile integral, contractile front velocity and distal latency in tests conducted in the upright or supine position. Due to the significant decreased normative range of the metrics in the upright position, researchers suggested that the cut-off values for abnormal function should be adjusted if high resolution manometry is performed in the upright position.
- "A Study of Interobserver Agreement with High Resolution Esophageal Pressure Topography and Impedance Manometry," (P582) by Erick R. Singh, MD, Georgia Health Sciences University, Augusta, GA and colleagues, used high resolution impedance and high resolution manometry testing to assess bolus transit and identify esophageal contraction patterns to give a more complete study of esophageal function. Researchers from the Division of Gastroenterology, Georgia Health Sciences University, found an incremental benefit in diagnosing esophageal dysfunction with the addition of high resolution impedance to high resolution manometry.
Poster presentations about high resolution anorectal manometry include:
- "High Resolution Anal Pressure Topography in Chronic Constipation and Healthy Asymptomatic Volunteers," (P1565) by Vanessa Costilla, MD, Mayo Clinic Arizona, Scottsdale, AZ, and colleagues, presented data from one of the first studies to use high resolution anorectal manometry to compare the anorectal pressure measures of chronic constipation patients with healthy, asymptomatic patients. Researchers from Mayo Clinic Arizona and Dartmouth-Hitchcock Medical Center completed 2-D HRM using ManoScan to find that patients with chronic constipation had significantly lower anorectal resting pressure, initial squeeze pressure, terminal squeeze pressure, squeeze fatigue rate and anal canal length compared with the healthy patient group. Chronic constipation patients also demonstrated a significantly higher urge to defecate and increased balloon expulsion time compared with the healthy patient group. The researchers concluded that anorectal high resolution manometry facilitates the evaluation of anorectal dynamics.
"As we continue to learn about the clinical value of ManoScan high resolution manometry through studies such as those presented at this conference, it is clear that it provides us with important new information about esophageal pressure and motor function as well as anorectal function that can help us more effectively treat GI diseases," said John Pandolfino, MD, Northwestern Memorial Hospital, Chicago, IL. "This technology provides physicians with valuable information that could potentially help correlate patient symptoms with measurements of esophageal and anorectal function."
The American College of Gastroenterology is a recognized leader in educating GI professionals and the general public about digestive disorders. Their mission is to serve the evolving needs of physicians in the delivery of high quality scientific, humanistic and cost-effective health care to gastroenterology patients. For more information, visit http://gi.org.
About ManoScan™ High Resolution Manometry
ManoScan high resolution manometry pioneered solid state high resolution manometry (HRM) and remains the market leader in comprehensive solutions for assessing gastrointestinal motility. 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.
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 impedance, and the SmartPill® GI 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 www.givenimaging.com.
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 ability of the Company to reach agreement on any strategic alternative and/or to complete any such alternative, as well as 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 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.
For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
Israel Investor Contact:
Gelbart Kahana Investor Relations