FDA approves capsule endoscopy device for visualization of the colon

The FDA has approved a capsule endoscopy device for visualization of the colon, giving PillCam COLON clearance under the direct denovo classification for devices with low to moderate risk that have no predicate in the marketplace, according to a manufacturer’s statement.

According to an announcement by Given Imaging Ltd., the device is designed to detect colon polyps in patients “after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.”

According the manufacturer, the device includes two miniature color video cameras, a battery and an LED light source. After ingestion by the patient, it transmits up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred to a computer that compiles the video data for physician review.

The manufacturer cited an 884-patient, 16-site clinical trial that compared the accuracy and safety of the device to optical colonoscopy.

“Results from this clinical trial demonstrated that the sensitivity for PillCam COLON was 88% and specificity was 82% in detecting adenomas at least 6 millimeters in size,” according the manufacturer. In its statement, Given Imaging said the FDA based its clearance decision on an analysis of this clinical trial data that used a more restrictive methodology for matching polyps.

“In this analysis, which was conducted on hyperplastic polyps and adenomas, the positive percent agreement for PillCam COLON and optical colonoscopy was 69% and negative percent agreement was 81% for polyps at least 6 millimeters in size,” the company reported.

In November 2013, the device was approved for reimbursement by Japan’s Central Social Insurance Medical Council.