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Given Imaging s PillCam COLON Receives CE Mark in European Union
New Video Capsule to Visualize the Colon to Be Unveiled at United European Gastroenterology Week
YOQNEAM, ISRAEL, Oct 20, 2006 (MARKET WIRE via COMTEX News Network) -- Given Imaging Ltd. (NASDAQ: GIVN) today announced that it received the CE Mark to market PillCam(TM) COLON throughout the European Union. PillCam COLON was developed as a diagnostic test to visualize the colon. To be unveiled to physicians at the United European Gastroenterology Week (UEGW) in Berlin, Germany from October 21-25, PillCam COLON can be used with The PillCam(R) Platform. The Company will release the PillCam COLON to the market gradually following the completion of additional clinical trials.
PillCam COLON is the third video capsule to be developed and manufactured by Given Imaging Ltd. The Company expects to file for clearance of PiIlCam COLON with the U.S. Food and Drug Administration by the end of 2006. The capsule measures 11 mm by 31 mm -- roughly the size of a large vitamin pill. Since the lumen of the colon is wider than the small bowel and it is highly compartmentalized, the Company has integrated new features into PillCam COLON. The capsule has tiny cameras at each end which capture 4 images a second for up to 10 hours. Each camera contains automatic lighting control and captures more than twice the coverage area and depth of field of the PillCam(TM) SB capsule that is used to diagnose diseases in the small intestine. Pivotal multi-center trials are underway in Europe and the U.S.
"Today begins a new chapter for our Company and confirms our leadership in the field of capsule endoscopy. Our ultimate goal is to deliver innovative, patient-friendly products that improve how G.I. disorders are diagnosed and treated," said Homi Shamir, president and CEO of Given Imaging. "To this end, the initial PillCam COLON data is encouraging and we believe it will be an effective tool for physicians to visualize the colon."
Data from the first European clinical trial for PillCam COLON will be presented at UEGW. A single-center prospective pilot study conducted by investigators at Erasme University Hospital in Belgium compared PillCam COLON with colonoscopy. Thirty-six (n=36) of the 41 patients enrolled in the study were analyzed. PillCam COLON identified polyps of any size in 19 of 25 patients, or 76%, and significant polyps, defined as at least one polyp measuring 6 mm or more than three polyps of any size, in 10 out of 13 patients, or 77%. Seven polyps not captured during colonoscopy were also identified by PillCam COLON. The overall sensitivity of PillCam COLON to detect polyps was 77% and specificity was 70%. The investigators concluded that PillCam COLON visualized the entire colon in the majority of cases and provides encouraging sensitivity and negative predictive values for the detection of significant lesions.
How PillCam COLON Works
A patient swallows the PillCam COLON capsule with a glass of water. A prep, as well as additional prokinetic agents to enhance capsule propulsion, are also part of the PillCam COLON capsule procedure. The platform for PillCam COLON includes the same components as PillCam SB and ESO including a sensor array and data recorder. Upon completion of the procedure, the physician downloads the recorded data to a RAPID workstation to review the images.
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