Israel-based Given Imaging has secured regulatory clearance in Japan for its PillCam COLON, a video capsule that can help in the diagnosis of colonic disease in patients who are unable or unwilling to undergo colonoscopy.
Given Imaging CEO and president Homi Shamir noted that the Pharmaceuticals & Medical Devices Agency’s clearance of PillCam COLON in Japan, the world’s second largest healthcare market, represents an important accomplishment for the firm.
"The decision could expand our potential customer base in Japan from approximately 1,000 today to potentially 10,000 and will help in enhancing adherence to screening guidelines for over 1,000,000 potential patients," Shamir added.
Although screening guidelines require anyone who is more than 40 years old to undergo a fecal occult blood test (FOBT), only 25% of the population actually gets tested.
Even after a doctor identifies blood in a patient’s feces, which can be a strong indication of colon cancer or other diseases, only 54.7%of such patients undergo colonoscopy tests in order to confirm the diagnosis.
The company claims that its PillCam COLON’s ease of use and minimally-invasive profile may appeal to patients who are not willing or unable to undergo such tests.
Equipped with two miniature color video cameras – one at each corner, a battery and an LED light source, the PillCam COLON video capsule, measuring 11 mm X 31 mm, can be swallowed by a patient.
Following the injestion, it can transmit up to 35 frames for each second for approximately 10 hours to a recording device, which has to be worn by the patient.
The data gets transferred from the device to a computer that uses RAPID software, which compiles the video data that would allow a doctor to review and report the results of the PillCam study.
From the time of the consuming of the video capsule to its excretion, a patient should not be exposed to any source of electro-magnetic fields.