SOURCE: Given Imaging

Given Imaging

May 10, 2011 09:00 ET

Given Imaging Announces New Clinical Studies Recommend Increased Use of High Resolution Manometry to Diagnose Motility Disorders

Podium Presentation Suggests ManoScan™ High Resolution Manometry Is an Important Tool for Determining Treatment Efficacy

CHICAGO, IL--(Marketwire - May 10, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that several new studies recommend the value of using ManoScan high resolution manometry to definitively diagnose and treat gastrointestinal motility disorders. Additional data showed that ManoScan provides important information about patients' disease severity, which enables physicians to more precisely treat their motility disorders. All of the studies were presented at Digestive Disease Week® (DDW) 2011, taking place here from May 7-10 at the McCormack Place Convention Center. Given Imaging is exhibiting at booth #2143 at the conference.

"Esophageal motility disorders such as achalasia are often extremely uncomfortable and affect patients' quality of life in a very significant way. The availability of tools such as high resolution manometry allows us to better diagnose patients and, thus, refine treatment to achieve the best possible outcomes for our patients," said John Pandolfino, MD, Associate Professor, Northwestern University. "Based on the results of these studies, we would recommend using this technology as part of the standard diagnostic algorithm for treating and evaluating complaints associated with esophageal motility disorders."

A podium presentation, abstract#363, led by Thomas B. Nealis, MD, Division of Gastroenterology, Feinberg School of Medicine, Northwestern University, analyzed the changes in the classification of sub-types of achalasia, a disorder of the esophagus, using high resolution manometry before and after therapeutic intervention. The study authors reviewed 32 patients who underwent the ManoScan procedure one week after undergoing treatment. Overall, the manometry data suggested that therapy changed the achalasia sub-type classification in 64% of patients. Further, poster presentation Sa1406, presented by researchers at Temple University, PA, concluded that esophageal high resolution manometry is a useful tool to categorize achalasia patterns as well as to correlate symptoms with these patterns.

Additional data on physician utilization of ManoScan were presented in several sessions throughout the four-day conference. Poster presentation Sa1123, from researchers at Northwestern University, showed that a smaller diameter assembly high resolution manometry system provided results comparable to standard assembly and offered improved ease of placement and increased patient tolerance.

Three studies also featured during DDW analyzed the classification systems and inter-observer agreement for interpreting ManoScan High-Resolution Manometry System data. Poster presentation Sa1384 by lead author Sabine Roman, MD, Division of Gastroenterology, Department of Medicine, Feinberg School of Medicine, Northwestern University, concluded that the use of established metrics, such as the Chicago Classification system to analyze esophageal high resolution manometry data, increased the inter-observer agreement among physicians with a wide range of clinical experience. This data was further supported by a poster presented by researchers from Washington University of St. Louis in abstractSa1126. Their study concluded that Clouse plots, an on-screen pressure volume measurement tool, positively impacted the ease of interpretation, even among physicians new to the technology. Poster presentation Tu1321 is the first published normal values data for various parameters of anorectal high resolution manometry, a new diagnostic tool to determine motility disorders that cause fecal incontinence or constipation. The study authors concluded that gender-specific normal value ranges will generate more accurate reports and help physicians diagnose anorectal disorders.

A poster presented by researchers from the University of Kansas Medical Center, abstractSa1106, analyzed the feasibility of high resolution manometry in evaluating longitudinal muscle dysfunction. Additional data from Northwestern University in abstractSa1124 utilized findings from high resolution manometry tests as the basis for proposing that the spastic nutcracker be reclassified as the jackhammer esophagus (a condition consisting of frequent repetitive esophageal contractions).

About Achalasia
Achalasia is a relatively rare disorder of the esophagus that makes it difficult for food and liquid to pass into the stomach. Achalasia is caused by a malfunction in the nerves controlling the esophagus muscles and the valve (sphincter) between the esophagus and stomach1.

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. DDW is 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. 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 ManoScan
The ManoScan High Resolution Manometry Platform provides a unique blend of accuracy, durability, and ease of use. Its proprietary tactile pressure-sensing technology yields unparalleled measurement precision with intuitive ManoViewsoftware offering diagnostic analysis ability. The ManoScan platform is a modular system designed to allow precise selection of diagnostic modalities and easy upgrades.

All medical procedures carry some risks. The risks of catheter insertion into the nasal passage include: discomfort, nasal pain, minor bleeding, runny nose, throat discomfort, irregular heartbeat with dizziness, and perforation. In rare instances, the catheter may be misdirected into the trachea causing coughing or choking, or the catheter may shift up or down causing false results. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. The system is not compatible for use in an MRI magnetic field.

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® wireless and Digitrapper® pH and impedance products. Given Imaging is committed to delivering breakthrough innovations to the GI community and to 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.

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1http://www.mayoclinic.org/achalasia/

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