Given Imaging Announces New Data Showing ManoScan(R) High Resolution Manometry Improves Gastroenterologists' Ability to Detect and Diagnose GI Tract Disorders

Many Other Studies Confirm the Clinical Value of Given Imaging's Products in Patients With Functional Heartburn and Refractory GERD and the Utility of Chicago Classification System to be Presented at Digestive Disease Week(R)

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| Source: Given Imaging Ltd.

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. 

To further validate the diverse application of ManoScan, podium presentation 992, 'Lower Esophageal Sphincter (LES) Length' Interrogated With 3D-High Resolution Manometry (3D-HRM): What Is Being Measured?, led by Frédéric Nicodème, M.D., M.Sc., Northwestern University, compared lower esophageal sphincter (LES) length measurements from the standard pull-through technique with esophagogastric junction (EGJ) pressure data measured by ManoScan ESO 3D. Researchers found that EGJ measurements from ManoScan ESO 3D were significantly shorter than LES length determined by the traditional pull-through approach. Researchers concluded that this data suggests that hiatal anatomy may be a large factor in determining EGJ measurements.   Poster Tu1853, Unique High Resolution Manometry Esophagogastric Junction Pressure Features Among PPI Non-Responders Subgrouped by pH-Impedance Studies, led by Frédéric Nicodème, M.D., M.Sc., Northwestern University, uniquely applied esophageal high resolution manometry to determine if the data points collected by ManoScan ESO could adequately distinguish among symptomatic patient sub-groups that do not respond to proton-pump inhibitor (PPI) therapy. The 160-patient study analyzed the characteristics of healthy controls and symptomatic patients to find that the most important points of differentiation were the data quantifying the relationship between crural diaphragm contractions and esophagogastric junction. These findings validate the usefulness of esophageal high resolution manometry in distinguishing patients with functional heartburn from patients with refractory GERD. 

Other relevant studies involving ManoScan AR include Development of New Parameters to Evaluate Anorectal Function Using High-Definition Anorectal Manometry (HDM), the Anal Contractile Integrated (Aci), the Post Squeeze Pressure (Psp), the Anal Integrated Relaxation Pressure (Airp), and the Sliding Velocity in the Anal Canal (Svac), poster Sa2034, from the Digestive Physiology and Motility Lab, University of Veracruz, Mexico. Researchers collected measurements for the anorectal function and topography pressure patterns in 40 healthy volunteers and in 20 symptomatic patients in order to develop normative values for high resolution anorectal manometry. Data was categorized into four parameters including Anal Contractile Integrated (ACI) measurements, Post Squeeze Pressure (PSP), anal integrated relaxation pressure (aIRP) and sliding velocity in the anal canal (SVAC). Normal values found were ACI 815 ± 18, PSP 49 ± 11.5 mmHg, SVAC 0.22 ± 0.11 ds/dt, cms-1 and aIRP 24.7 ± 7.90 mmHg. Researchers concluded that the new normative parameters defined in this study will be useful in distinguishing normal and abnormal anorectal function in future clinical settings.  

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. ManoScan is the only modality to use Chicago Classification, a standardized categorization system for identifying and classifying motility disorders.  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.

Manometry products have certain risks associated with catheter insertion. Medical, endoscopic or surgical intervention may be necessary to address complications, should they occur. These systems are not compatible for use in an MRI magnetic field.

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.

Forward-Looking Statements

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