ORLANDO, Fla., Nov. 1 /PRNewswire-FirstCall/ -- Given Imaging the global leader in capsule endoscopy, today announced the complete data from a study of PillCam(TM) ESO in the detection of abnormalities of the esophagus in patients with gastroesophageal reflux disease (GERD), presented today at the 69th annual scientific meeting of the American College of Gastroenterology in Orlando Florida. Results of the study demonstrate that esophageal capsule endoscopy (ECE) with PillCam(TM) ESO was as accurate as conventional endoscopy (EGD), in detecting abnormalities that commonly occur in GERD patients. All patients reported greater satisfaction with the ECE procedure compared with EGD.
“This study demonstrates that ECE meets the gold standard of EGD in the detection of abnormalities of the esophagus associated with GERD,” said Blair Lewis, MD, Associate Clinical Professor of The Mount Sinai Medical Center, NY. “A key finding of the study was the accurate visualization of Barrett’s esophagus, a precancerous condition that occurs in approximately 10 -15 percent of patients with chronic GERD symptoms and may lead to esophageal cancer, the second fastest growing cancer in the western world.”
“By providing a patient-friendly alternative, ECE allows us to potentially avoid performing the more invasive conventional endoscopy procedure in a large percentage of patients, and narrow our endoscopic focus on patients that truly need it. Additionally, since patients seem to prefer ECE, we may see an increase in the rate of adherence to screening guidelines which could lead to better clinical outcomes,” said Glenn Eisen, MD, Associate Professor, Oregon Health and Science University in Portland.
The pivotal, multi-national study compared the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the four-frames per second version of the PillCam ESO and EGD in detecting esophagitis, Barrett’s esophagus or other esophageal abnormalities in patients with GERD symptoms. Patient satisfaction with each procedure also was assessed. Patients underwent ECE followed by EGD on the same day, and the results of each approach were compared. Physicians were blinded to the results of the earlier test. Data were obtained from 106 patients undergoing endoscopy for evaluation of GERD symptoms or for surveillance of confirmed Barrett’s esophagus.
Results show an overall PPV of 97% and a NPV of 88% in diagnosing esophageal pathology. In detection of Barrett’s esophagus PPV and NPV were 97% and 99%, respectively. PPV and NPV were 97% and 94%, respectively, in diagnosis of esophagitis. Additionally, patients reported significantly greater satisfaction with ECE compared with EGD in three different measures: ease of insertion, comfort during procedure, and convenience.
For conventional esophageal endoscopy, patients are given conscious sedation and then a small, lighted flexible tube is inserted through the mouth into the esophagus and stomach to examine for abnormalities. Conventional endoscopy is performed by a physician. Conscious sedation-related cardiopulmonary complications are the most common complications associated with conventional endoscopy. Additionally, as a result of the sedation, patients undergoing the procedure usually miss one or two days of work and require transportation assistance in returning home.
With esophageal capsule endoscopy, the patient swallows a capsule that transmits video images of the esophagus to a data recorder that captures the images for subsequent evaluation. The capsule takes just a few minutes to traverse the esophagus, after which the patient can return to daily activities. In studies to date, ECE with PillCam(TM) ESO has demonstrated a good safety profile and has been generally well tolerated.
The four-frames per second PillCam ESO video capsule for visual examination of the esophagus was cleared for marketing by the U.S. Food and Drug Administration on October 25, 2004. A “special 510 (k)” application for clearance to market a 14 frames per second PillCam ESO was filed with the FDA on October 26, 2004. Special 510 (k) approvals are typically granted within 30 days, but there can be no assurance that the approval will be granted in that time frame.
About GERD
According to the American College of Gastroenterology, over 60 million people in the United States alone experience acid indigestion at least once a month and some studies have suggested that over 15 million Americans experience acid indigestion daily. In many cases, proper use of over-the- counter medicines and lifestyle modifications provide effective management of GERD symptoms. Serious complications can occur if GERD is left untreated, including severe chest pain that can mimic a heart attack, esophageal stricture (a narrowing or obstruction of the esophagus), bleeding, or Barrett’s esophagus (a pre-malignant condition of the esophagus).
About Given Imaging
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company’s technology platform is the Given(R) Diagnostic System, featuring the PillCam(TM) SB video capsule, a disposable capsule that captures video after it is ingested by the patient. The PillCam(TM) SB video 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 60 other countries and has benefited more than 145,000 patients worldwide. The PillCam(TM) ESO video capsule, for visual examination of the esophagus, has been cleared by the FDA and a higher frame rate version will be commercialized pending FDA clearance. 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 Tokyo, Madrid and Sydney. For more information, visit http://www.givenimaging.com/.
This press release contains forward-looking statements about Given Imaging, including projections about our business, our future revenues and our future 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 possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission.
Given Imaging Ltd.
CONTACT: Mark Gilreath, +1-770-662-0870, of Given Imaging, or Fern Lazaror David Carey, both of Lazar Partners Ltd. +1-917-362-2264, or +1-646-239-6231, or flazar@lazarpartners.com, or dcarey@lazarpartners.com, for GivenImaging
Web site: http://www.givenimaging.com/