YOQNEAM, Israel, Dec. 6 /PRNewswire-FirstCall/ -- Given Imaging Ltd. today announced that a pooled analysis published in ENDOSCOPY (2005: 37:960 -965) concluded that capsule endoscopy is the best method for detecting small bowel disease non-invasively. Using a master database of 24 prospective studies comparing PillCam SB with another diagnostic modality (push enteroscopy, colonoscopy, or small-bowel series), the analysis determined that PillCam SB identified pathology in 70% of the exams, double the yield of the comparative methods (p =530). When individual pathologies were counted, 90% of the pathologies capsule endoscopy detected could not be identified by any other method. The lead author of the study was Blair Lewis, MD, Clinical Professor of Medicine and Gastroenterology, Mount Sinai School of Medicine, NY. ENDOSCOPY is the official publication of the European Society of Gastrointestinal Endoscopy.
“The results of this study demonstrate the power of capsule endoscopy and support its role as a first line diagnostic tool for differential diagnosis of suspected diseases of the small bowel,” said Blair Lewis, MD, Clinical Professor of Medicine and Gastroenterology at Mount Sinai School of Medicine. “Interestingly, our conclusions regarding capsule endoscopy’s ability to double the diagnostic yield have been confirmed by many other clinical trials comparing capsule endoscopy to other modalities.”
The patients in the database had undergone multiple tests prior to their enrollment in their trial. Patients had undergone an average of 6.77 procedures including gastroscopy, colonoscopy, small-bowel series, push- enteroscopy, computed tomography (CT), abdominal radiography, bleeding scan, angiography, and intraoperative enteroscopy, but had never received a definitive diagnosis of disease. Of the 24 studies reviewed for this pooled analysis, fourteen (including 310 patients) were categorized as bleeding studies and 10 (including 220 patients) were categorized as non-bleeding small bowel disorder studies.
Highlights of the analysis include: * A total of 1349 individual pathologies of small bowel were identified in 530 patients; * Only PillCam SB was able to identify 87 percent of the 1349 instances of small bowel disease; * PillCam SB identified disease in approximately 70 percent of the examinations, double the yield of other methods; * PillCam SB delivered new findings in 50 percent of the patients studied.
ENDOSCOPY is one of the world’s leading journals with respect to scientific impact in the area of gastrointestinal endoscopy. ENDOSCOPY is published by Thieme Publishers, Stuttgart / New York. For more information on ENDOSCOPY’s editorial policy as well as on its aims and scope, please visit the journal’s homepage at http://www.thieme.de/endoscopy.
About Given Imaging
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract. The company’s technology platform is the Given(R) Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam(TM) SB capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 260,000 patients worldwide. The PillCam(TM) ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. Given Imaging’s headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit http://www.givenimaging.com.
This press release contains forward-looking statements about Given Imaging, including projections about our business and our future revenues, expenses and profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as “anticipates,” “estimates,” “expects,” “intends,” “plans,” “believes,” and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the impact of the newly adopted SFAS 123R for expensing option-based payments, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities and Exchange Commission.
Given Imaging Ltd.
CONTACT: Mark Gilreath of Given Imaging Ltd.; or Fern Lazarflazar@lazarpartners.com, or David Carey, dcarey@lazarpartners.com, both ofLazar Partners Ltd. for Given Imaging Ltd., +1-866-GIVEN-IR
