YOQNEAM, Israel, Nov. 2 /PRNewswire-FirstCall/ -- Given Imaging Ltd. today announced that three independent, PillCam SB studies of more than 670 patients were presented at the 70th Annual Scientific Meeting of the American College of Gastroenterology (ACG takes place in Honolulu, Hawaii from October 31 to November 2). The studies showed that capsule endoscopy not only identifies small bowel tumors and previously undetected Crohn's disease, it also leads to meaningful changes in patient management
Two retrospective studies from Thomas Jefferson University in Philadelphia, reviewed the medical records including medication and RAPID videos of 466 patients. The first, led by Anthony Infantolino, M.D., reviewed files of 366 (84.9%) that underwent capsule endoscopy between 2001 and 2005 after inconclusive upper and lower endoscopies. Of these, a cause for the obscure GI bleeding (OGIB) was identified in 304, or 83%. The leading cause of the bleeding was angioectasias, identified in 42.1% of the cases reviewed. Small bowel tumors were found in 4.9% of the patients. Other causes for OGIB included gastritis (21%), small bowel ulcerations (11%), small bowel erosion (9%), duodenitis (8%) and active bleeding with no cause (8%). The study concluded that capsule endoscopy is the diagnostic modality of choice for investigating OGIB, with small bowel tumors being discovered at a rate higher than previously reported.
Sidney Cohen, M.D., from Thomas Jefferson University looked at the same 466 cases, but focused on the overall experience of capsule endoscopy. His results showed that PillCam identified a cause of OGIB in 76.8% of patients, as well as a possible cause of abdominal pain and diarrhea in 41.8% and 28% of patients, respectively. Among those patients with diarrhea, capsule endoscopy diagnosed Crohn's disease for the first time in 16%. It was also found that 57.6% of patients with colonic Crohn's disease had small bowel involvement. Dr. Cohen concluded that capsule endoscopy is the clear choice for evaluating not only obscure gastrointestinal bleeding but also early Crohn's disease.
Kevin Olden, M.D., from the Division of Gastroenterology at the University of South Alabama in Mobile, conducted a retrospective study of 210 cases to determine whether capsule endoscopy findings led to a change in patient management. Overall, Dr. Olden concluded that capsule endoscopy led to a change in patient management in 38.6% of the cases reviewed. In obscure-occult bleeding patients, the number increased to 41.9%. The study also concluded that capsule endoscopy findings reassure patients and eliminate the need for further testing.
"Recent large studies with consistent clinical data continue to support the use of PillCam capsule endoscopy as a first-line diagnostic tool for patients who suffer from unresolved G.I. symptoms," said Gavriel D. Meron, president and chief executive officer of Given Imaging. "As additional evidence-based studies emerge, we anticipate that payers will update and expand their coverage policies to reflect these new data."
About the American College of Gastroenterology
The ACG was formed in 1932 to advance the scientific study and medical treatment of disorders of the gastrointestinal tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the needs of clinical gastroenterology practitioners.
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 230,000 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., +1-770-662-0870; or FernLazar, flazar@lazarpartners.com, or David Carey, dcarey@lazarpartners.com,both of Lazar Partners Ltd., 1-866-GIVEN-IR
Web site: http://www.givenimaging.com/
