ORLANDO, Fla., May 21, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that numerous studies presented at Digestive Disease Week ® confirm the value of ManoScan high resolution manometry and the utility of applying the Chicago Classification System, ManoScan's proprietary standardized categorization system, to identify and classify motility disorders. Additional data were presented validating the use of ManoScan ® AR and ManoScan ® ESO 3D. All data were presented during Digestive Disease Week (DDW) taking place May 18 - 21, 2013 at the Orange County Convention Center, Orlando, FL. "The studies presented at DDW show that by using Chicago Classification we can classify patient populations according to the severity of their motility disorders," said Sabine Roman, M.D., Ph.D., Lyon I University. "ManoScan is the only product that integrates this clinically proven categorization system, which gives us the valuable information we need to make important therapeutic management decisions for patients." Several podium and poster presentations at DDW showed a range of clinical applications involving high resolution manometry in patients with achalasia, abnormal anorectal function, reflux and functional heartburn. Specific studies underscoring ManoScan's proprietary standardized categorization system, Chicago Classification, were also highlighted and include:
- Is the Chicago Classification for Esophageal Motility Disorders Useful to Predict Symptom Severity?, poster Sa1323: Researchers led by Sabine Roman, MD, PhD., Lyon I University, analyzed the application of the Chicago Classification system in accurately categorizing esophageal motility disorders according to symptom severity. Researchers conducted a randomized study evaluating 75 patients who had undergone high resolution manometry. Data from the study concluded that the Chicago Classification can be used to segregate esophageal motility disorders according to symptom severity. Researchers also found that patients with achalasia had more severe dysphagia than the normal subjects.
- The Chicago Classification of Esophageal Motility Disorders and Associated Self Report Symptom Severity, Psychological Distress, and Visceral Sensitivity, poster Su1898: Researchers at the Feinberg School of Medicine, Northwestern University, presented data from a retrospective study of 894 patients who underwent high resolution manometry. Patients were segmented into four subgroups according to Chicago Classification criteria: normal, borderline motor function, abnormal motor function and achalasia/esophagogastric junction (EGJ) outflow obstruction. Patients completed an Impaction Dysphagia Questionnaire (IDQ) that self-reported dysphagia severity. Data from this survey were analyzed and compared to the segmentation of patient subgroups by the Chicago Classification criteria. Researchers concluded that patients in the subgroups with abnormal motor function and achalasia/EGJ outflow obstruction had significantly higher IDQ scores when compared to patients in the other two subgroups validating that Chicago Classification accurately segmented motility disorder severity.
- Patients Over the Age of 40, Diagnosed With Type 1 Achalasia by Chicago Classification, Show the Best Indication for Pneumatic Dilatation, poster Su1511: Researchers at Nippon Medical School, Tokyo, Japan and Inzai, Japan, assessed the impact of the Chicago Classification System on determining the outcomes of pneumatic dilatation (PD), a procedure that aims to enlarge the esophageal lumen, in patients with achalasia. Over a period of more than nine and a half years, 73 patients were diagnosed with achalasia using high resolution manometry. Patients were categorized using Chicago Classification into three subtypes ranging from least severe, Type 1 achalasia, to most severe, Type 3 achalasia. Researchers found that patients categorized with Type 1 achalasia had the best response to PD compared with Type 2 and Type 3 subcategories of patients. Furthermore, the response rate to PD in patients with Type 1 was significantly greater than in patients with Type 2. Researchers also found that age is a useful indicator to predict PD outcomes and concluded patients over 40 years of age with Type 1 achalasia show the best indication for PD.
About Digestive Disease Week ®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 (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org. 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, 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. 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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, 2012. 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