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Given Imaging files PillCam Colon video capsule application for PMDA approval

Given Imaging has filed PillCam Colon 2 video capsule's application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for approval.

The 11.6 mm X 31.5 mm PillCam COLON 2 capsule, which features two miniature color video
cameras, a battery and an LED light source, is designed for identifying colorectal cancer causing pathologies.

The application included positive results of PillCam COLON 2 pivotal trial which has enrolled 72 patients aged 40-75 years with colorectal cancer.

Two groups of readers were involved to read the results including one at the investigator site and the other at a central reading facility.

The company said as the lesions were already identified by a standard colonoscopy, the trial did not require specificity as an endpoint.

The results demonstrated that physicians could accurately identify 94% of polyps measuring 6 mm in size using PillCam COLON 2.

Jikei University School of Medicine department of endoscopy, gastroenterology and hepatology chairman and professor Hisao Tajiri said, "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."