Given Imaging, a developer of GI medical devices, has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval to use its PillCam Colon 2 video capsule as an identifying tool for colorectal cancer-causing pathologies.
The PillCam Colon 2 capsule measures 11.6mm X 31.5mm and features two miniature color video cameras, a battery and an LED light source.
When ingested by a patient, the capsule transmits up to 25 images a second for around ten hours, which are transferred to a computer and compiled as video data for analysis by a physician.
The PMDA application includes positive results of a pivotal trial which enrolled 72 patients aged 40-75 years to demonstrate the safety and efficacy of PillCam Colon 2.
Two groups of readers were involved to read the results, including one at the investigator site and the other at a central reading facility.
As the lesions were already identified by a standard colonoscopy, the trial did not require specificity as an endpoint, according to the company.
The results demonstrated that physicians could accurately identify 94% of polyps measuring 6mm in size using PillCam Colon 2.
Jikei University School of Medicine department of endoscopy, gastroenterology and hepatology chairman and professor Dr 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."
Given Imaging president and CEO Homi Shamir said the company believes the capsule will help physicians visualise and diagnose colon polyps effectively.
"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," Shamir said.