Given Imaging Ltd. (GIVN: Quote), a provider of specialty GI products and pioneer of capsule endoscopy, on Wednesday announced that it has filed for regulatory approval of PillCam COLON 2 in Japan.
The company noted that 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.
According to the firm, 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.
PillCam COLON 2 received the CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia.
Given Imaging President and CEO Homi Shamir said, "We are very pleased with the robust results of our PillCam COLON 2 clinical trial in Japan as well as the performance of the PillCam COLON 2 capsule. With an estimated addressable market of approximately one million procedures each year in Japan, PillCam COLON 2 represents a significant revenue opportunity for Given Imaging."
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by RTT Staff Writer
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