Noninvasive Alternative to Colonoscopy Approved for Sale in Japan

A novel imaging device that is advertised as a noninvasive alternative to colonoscopy has been cleared for sale by Japan's regulatory agency.

The clearance for sale in Japan, the world's second largest healthcare market, represents a substantial boost for Given Imaging Ltd's (Yokneam, Israel) PillCam Colon device. The Pillcam, an endoscopic capsule for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, was recently cleared for sale by the Japanese Pharmaceuticals & Medical Devices Agency (PMDA).

Approval of the PillCam marks an important step forward for the Japanese diagnostics community. Screening guidelines in Japan call for individuals over the age of 40 to undergo an annual fecal occult blood test. However, compliance with screening is low and only about a quarter of the population is actually tested. Detection of blood in a patient’s stool (which can be a strong indication of colon cancer or other diseases) demands investigation by colonoscopy, but only 54.7% of these patients opt to have this procedure. It is expected that PillCam Colon’s ease of use and minimally invasive profile will appeal to patients hesitant about undergoing a colonoscopy.

"The clearance of PillCam Colon in Japan, the world's second largest healthcare market, represents an important accomplishment for Given Imaging," said Homi Shamir, president and CEO of Given Imaging. "The decision could expand our potential customer base in Japan from 1,000 today to potentially 10,000 and will help in enhancing adherence to screening guidelines for over one million potential patients. Meaningful sales of PillCam Colon capsule will commence immediately after obtaining reimbursement. I do not want to discuss financial numbers at this time, because the level of indemnification is not known."

PillCam Colon received clearance for sale in Europe (CE Marking) in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia. Given Imaging is optimistic that the US Food and Drug Administration (FDA) will approve the PillCam Colon by the end of September 2013.

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Given Imaging Ltd.