FDA Approves PillCam COLON as Follow-up Test

An ingestible, pill-sized camera is now approved to look for polyps in patients who have incomplete colonoscopies. In late January, the U.S. Food and Drug Administration (FDA) cleared PillCam COLON (Given Imaging; Yoqneam, Israel), a capsule equipped with a miniature color video camera on each end, a battery, and LED light source.

Measuring 12 × 33 millimeters (0.47 × 1.3 inches) with a battery life of 10 hours, the capsule, when in motion, wirelessly transmits 35 images per second to a recording device worn by the patient. The images are uploaded to a computer and rendered into a video for the physician's review. Although there is no need for sedation or medical supervision, more bowel preparation is required than with colonoscopy.

“This is an exciting new device, and I expect doctors will start using it as soon as it is available in patients who have incomplete colonoscopies,” says Marta Davila, MD, a professor of medicine and head of the colon cancer screening program in the Cancer Prevention Center at The University of Texas MD Anderson Cancer Center in Houston.

The manufacturer estimates about 750,000 U.S. patients have an incomplete colonoscopy each year due to a long or tortuous colon, history of abdominal surgery, or advanced diverticular disease. They often must undergo additional procedures, such as CT colonography or barium enema, resulting in further discomfort, risks, and costs. PillCam COLON is better tolerated by patients, and Given Imaging anticipates it will cost slightly more than $500, the approximate price of the company's similar device for viewing the small intestine.

Despite the colon capsule's limited indication, Davila expects some patients may ask for it in place of other screening tests—and physicians may justifiably comply. “Although the capsule is not currently FDA-approved for screening, it might still be an option for patients who are unwilling or unable to undergo colonoscopy,” says Davila. “This might motivate them to finally get tested.” If the capsule finds polyps, however, a patient will still need a colonoscopy to remove them.

PillCam COLON's approval was based on an analysis of hyperplastic polyps and adenomas at least 6 millimeters in size from a 16-site study of 884 patients at average risk for colon cancer. It showed that the positive percent agreement for PillCam COLON and optical colonoscopy was 69% and negative percent agreement was 81%. Risks included capsule retention, aspiration, and skin irritation.

Later this year, Given Imaging plans to seek expanded approvals for PillCam COLON in patients with comorbidities who have a higher risk for colonoscopy complications and in patients being evaluated for inflammatory bowel disease, says Homi Shamir, the company's president and CEO. The company also plans to test the capsule as a screening tool for colorectal cancer.

PillCam COLON will have a phased launch in a limited number of locations. The device is commercially available in more than 80 countries, including Japan, China, Canada, and the UK.

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