Will Japan Swallow Pillcam® Colon 2 Trial Data?

In short

Earlier this year we covered the progress of Given Imaging’s Pillcam as it gained approval in Japan for use in small bowel visualisation and specifically disease diagnosis including Crohn’s. Now the company has filed for regulatory approval of PillCam® Colon 2 in Japan. Study results showed that using the device, physicians were able to accurately identify 94% of polyps that were at least 6 mm in size previously identified using standard colonoscopy.

Background

When it comes to visualising the inside of the gastrointestinal tract with a swallowable, remote control camera, it’s not a case of one size fits all. Given Imaging’s Pillcam Colon 2 is bigger than its sibling products, and has other features which mean it is optimised for colorectal purposes including adjustable frame rate and cameras at each end, all in the name of covering the maximum area possible.

In essence the PillCam Colon 2 video capsule is equipped with two miniature colour video cameras (one on each end), a battery and an LED light source. It measures 11.6 mm X 31.5 mm and is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses so-called RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.

The submission to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) includes the results of the PillCam Colon 2 pivotal clinical trial which was designed to evaluate the device as a tool to visualise the mucosal layer of the colon for pathologies including colorectal cancer.

A total of 72 patients aged 40-75 years were enrolled at three sites. Results were read by two groups of readers; one at the investigator sites and the other at a central reading facility. As agreed with PMDA, specificity was not a required endpoint of the trial, since the lesions being assessed for agreement were already identified by colonoscopy.

Physician comments

“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,” said Hisao Tajiri, M.D., Ph.D., Chairman and Professor, Department of Gastroenterology and Hepatology, and Department of Endoscopy, The Jikei University School of Medicine.

Company comments

“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. We believe that PillCam Colon 2 can be a useful tool for physicians to visualise and diagnose colon polyps,” said Homi Shamir, president and CEO, Given Imaging. “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. We would like to thank the physicians and hospitals who participated in the trial for their dedication and support.”

Regulatory status

PillCam Colon 2 received the CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia. It is not approved for use in the United States.

Source: Given Imaging Ltd., Marketwire