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News Breaks | | | | September 19, 2012 | | 05:35 EDT |  | GIVN | Given Imaging submits PillCam COLON 2 pivotal trial data to Japan's PMDA
Given Imaging announced that it has filed for regulatory approval of PillCam COLON 2 in Japan. The results of the study showed that using PillCam COLON 2, physicians were able to accurately identify 94% of polyps that were at least 6 mm in size previously identified using standard colonoscopy. The submission to the Japanese Pharmaceuticals and Medical Devices Agency, or PMDA, includes the results of the PillCam COLON 2 pivotal clinical trial which was designed to evaluate the PillCam COLON 2 as a tool to visualize the mucosal layer of the colon for pathologies including colorectal cancer. The results of this pivotal study show that PillCam COLON 2 can be used as another tool in the fight against colon cancer and could be particularly useful for those patients who are unable or unwilling to get a colonoscopy or have had prior incomplete colonoscopies. PillCam COLON 2 received the CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia. | |
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