Healthcare Industry News: Capsule Endoscopy
News Release - April 30, 2008
Agile(TM) Patency Capsule Clears Stricture Patients for Small Bowel Diagnostic ProcedureStudy Concludes More Than Half of Patients With Strictures May Undergo Small Bowel Capsule Endoscopy; Subsequent PillCam(R) SB Procedure Found Significant Findings in Many Patients
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Apr 30, 2008 -- Given Imaging Ltd. (NasdaqGM:GIVN ) today announced a study entitled, "Agile Patency System Eliminates Risk of Capsule Retention in Patients with Known Intestinal Strictures who Undergo Capsule Endoscopy," appeared in the May edition of Gastrointestinal Endoscopy. The study utilizing the AgileTM patency capsule aided physicians in identifying patients with known strictures (areas where the GI tract has narrowed) whose small bowel patency was sufficient for the PillCam® SB video capsule to pass. Capsule Endoscopy helped physicians diagnose numerous small bowel diseases in these patients. The study was led by Juan M. Herrerias, MD, of Virgen Macarena University Hospital, Seville, Spain.
"Physicians have limited options to identify small bowel disorders in patients with strictures due to the high risk of the patient retaining the capsule endoscope. The Agile patency capsule safely identifies those patients who are able to undergo further evaluation using PillCam® SB, so the physician can effectively diagnose their small bowel disorder and identify a proper treatment," said Prof. Herrerias.
The Agile patency capsule study assessed the ability of the device to identify which patients with known strictures may safely undergo small bowel Capsule Endoscopy. Of 106 patients with known strictures, the Agile patency capsule examination demonstrated that 56% of patients had a patent small bowel. These patients all proceeded to have a safe PillCam SB evaluation. Forty-one percent were found to have significant findings, including ulcers, tumors and vascular lesions.
The Agile patency capsule allows physicians to determine whether small bowel patency is sufficient for safe passage of the PillCam SB video capsule. Small bowel follow through (SBFT) provides radiographic images only and has been shown to be unreliable when verifying functional patency of the small bowel. Without the Agile patency capsule, some patients with known strictures included in the study would likely have been determined to be ineligible for small bowel Capsule Endoscopy and, therefore, would not have benefited from PillCam SB.
The Agile patency capsule is the same size and shape as the PillCam SB video capsule. It includes two timer plugs that seal the dissolvable capsule's body. If the Agile patency capsule is retained in the small bowel, the timer plugs begin to erode after 30 hours, allowing penetration of intestinal fluids and subsequent dissolution of the capsule.
The Agile patency capsule is a unique product from Given Imaging. No other product exists solely to determine eligibility for small bowel Capsule Endoscopy.
About Agile(TM) Patency System
Cleared by the U.S. Food and Drug Administration in May 2006, the Agile Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures.
About Given Imaging Ltd.
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 PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has a number of available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 650,000 patients worldwide have benefited from the PillCam Capsule Endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). For more information, visit http://www.givenimaging.com.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam COLON (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2007. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
Source: Given Imaging
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