New Clinical Data on Given Imaging's PillCam Presented at Fifth International Conference on Capsule Endoscopy15 March 2006
The PillCam ESO Esophageal Varices Working Group presented initial results from its large international trial to determine PillCam ESO's ability to detect esophageal varices, a serious side effect of portal hypertension. Ninety-seven patients underwent PillCam ESO followed by sedated upper endoscopy (EGD). PillCam ESO detected varices in 62 patients, 63% of the study population, compared to EGD exam, in which the physician found varices in 69% (n=67) of the patients. When compared to EGD, PillCam ESO had a sensitivity of 86.6%, specificity of 86.7%, a positive predictive value of 93.5% and a negative predictive value of 74.3%. The authors concluded that PillCam ESO is safe and able to detect esophaegeal varices in patients being screened. They also concluded that PillCam ESO is an accurate method for determining variceal size. Inflammatory Bowel Disease -- The AGILE Patency Capsule:Patients with small bowel problems such as Crohn's disease or damage fromusing non-steroidal anti-inflammatory (NSAID) drugs may not be able to passthe PillCam because of obstructions or strictures. The dissolvable AGILEPatency Capsule, which is similar in size to the PillCam SB capsule, isdesigned to be given to patients with suspected strictures or obstructionsto determine if the imaging PillCam SB will be able to pass. A study conducted by researchers at Bikur Holim and Assaf Harofeh Hospitalsin Israel assessed the ability of the AGILE Patency Capsule to predict thepatency of a patient's small intestine in 26 patients. To be included inthe study, x-ray evidence had to show that a patient had a narrow smallbowel or the physician had to suspect partial small bowel obstruction. Ofthe 26 patients, 19 or 73%, were able to pass the capsule. Fourteen of the19 patients passed the capsule intact and underwent PillCam SB for thesmall bowel. The authors concluded that a patient's ability to pass aPatency Capsule intact provides physicians enough assurance that a PillCamprocedure can be performed safely. -- The Lewis Score: Ian M. Gralnek, M.D., M.S.H.S, Associate Professor of Medicine, DavidGeffen School of Medicine at the University of California at Los Angeles(UCLA), Rappaport Family Faculty of Medicine, Technion Institute ofTechnology, Department of Gastroenterology at the Rambam Medical Center inHaifa Israel delivered a presentation on "The Lewis Index," a new indexbased on findings from capsule endoscopy exams and designed to measuresmall bowel mucosal disease activity. The proposed Lewis Index wouldsupplement the information gathered through existing indices such as theCrohn's Disease Activity Index, a subjective rating with lowreproducibility based on the physician and patient's assessment of theseverity of his/her disease; and two endsocopic indices: the Crohn'sDisease Endoscopic Index of Severity (CDEIS), which is limited to findingsin the colon, and the Rutgeerts Score used to assess post-operative mucosalhealing. Existing endoscopic scoring methods are hampered by only viewingcertain sections of the small intestine and a lack of data evaluatingprognostic significance with enough scientific integrity to be used as aprimary study endpoint. Using images obtained from capsule endoscopy exams,The Lewis Index Score is designed to be disease neutral (can be used toassess extent of Crohn's, NSAIDs, Vasculitis and radiation enteritis).Studies are underway to assess extent of disease activity in patients withknown Crohn's disease using the Lewis scoring method. The Lewis Index Scoreis planned to be exclusively incorporated as an integral part of the nextversion of Given's RAPID (RAPID 5). Pediatrics: A prospective study conducted by researchers at McGill University, SainteJustine Hospital and McMaster University in Canada evaluated 80 patientsover the course of a four-year period referred for suspected Crohn'sdisease, GI bleeding, polyposis or malabsorption. The authors concludedcapsule endoscopy alone was able to detect Crohn's disease in 42.2% or 49patients. A portion of patients, 12.2%, had an alternate diagnosis afterundergoing capsule endoscopy. The overall diagnostic yield for specificfindings was 55%. About ICCE: Started in 2002, The International Conference on Capsule Endoscopy is themain forum for leading gastroenterologists and key opinion leaders toexchange scientific, clinical and practical information about CapsuleEndoscopy. The next ICCE will take place in Paris France in June 2006. Formore information visit www.2006ICCE.com. About Given Imaging Given Imaging is redefining gastrointestinal diagnosis by developing,producing and marketing innovative, patient-friendly products for detectinggastrointestinal disorders. The company is developing a complete line ofPillCam™ video capsules for detecting disorders of the gastrointestinaltract. The company's technology platform is the Given® Diagnostic System,featuring the PillCam video capsule, a disposable, miniature video cameracontained in a capsule, which is ingested by the patient. The PillCam™SB capsule is the only naturally ingested method for direct visualizationof the entire small intestine. It is currently marketed in the UnitedStates and in more than 60 other countries and has benefited more than 300,000 patients worldwide. The PillCam™ ESO video capsule, whichprovides visual examination of the esophagus, has been cleared formarketing by the FDA. Additional capsules for visualization of the stomachand colon are under development. Given Imaging's headquarters,manufacturing and R&D facilities are located in Yoqneam, Israel; it hasdirect sales and marketing operations in the United States, Germany andFrance, and local offices in Japan, Spain and Australia. For moreinformation, visit http://www.givenimaging.com. This press release contains forward-looking statements about Given Imaging,including projections about our business, our future revenues and ourfuture profitability, within the meaning of Section 27A of the SecuritiesAct of 1933 and Section 21E of the Securities Exchange Act of 1934. Forexample, statements in the future tense, words such as "anticipates,""estimates," "expects," "intends," "plans," "believes," and words and termsof similar substance used in connection with any discussion of futureoperating or financial performance identify such forward-lookingstatements. Those forward-looking statements are not guarantees of futureperformance and actual results could differ materially from our currentexpectations as a result of numerous factors, including but not limited tothe following: changes in regulatory environment, our success inimplementing our sales, marketing and manufacturing plan, protection andvalidity of patents and other intellectual property rights, the impact ofcurrency exchange rates, the effect of competition by other companies, theoutcome of future litigation, the reimbursement policies for our productfrom healthcare payors, quarterly variations in operating results, thepossibility of armed conflict or civil or military unrest in Israel andother risks disclosed in our filings with the U.S. Securities ExchangeCommission. Mark GilreathGiven Imaging Ltd. Fern Lazar / David CareyLazar Partners Ltd.Phone: 1-866-GIVEN-IREmail ContactEmail Contact SOURCE: Given Imaging
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