Non-Invasive Device OK'd for Use After Incomplete Colonoscopy
The FDA has approved a new modality, a novel video capsule endoscopy device, to detect colon polyps in patients with incomplete optical colonoscopy in whom a complete evaluation of the colon is not technically possible.
PillCam COLON (Given Imaging Ltd.) received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market, the manufacturer stated in a press release.
The device consists of a small capsule (12 mm x 33 mm), designed to be swallowed, that is equipped with two miniature color video cameras on each end, a battery and an LED light source.
The cameras are able to transmit as many as four to 35 frames per second to a recording device for up to 10 hours. Data can then be transferred from the device to a computer using RAPID software for clinician review.
"We have made tremendous strides in increasing the number of people who are getting screened for colon cancer, starting at age 50 for the average risk individual. Colonoscopy is the most comprehensive option, but for up to 10% of individuals, achieving a complete colonoscopy may not be possible," Eric Hargis, CEO of the Colon Cancer Alliance said in a press release. "For those individuals, PillCam COLON capsule endoscopy could be an effective option to allow their gastroenterologist to complete a colon examination."
PillCam COLON is expected to benefit approximately 750,000 U.S. patients who experience incomplete colonoscopies each year. Those at risk include women, due to higher incidence of past pelvic surgeries and anatomical differences including particularly acute rectosigmoid angles in thin women.
Patients with a redundant or long colon, history of abdominal surgery or advanced diverticular disease are also at a higher risk for experiencing an incomplete colonoscopy.
FDA approval was based on data from a 16-site clinical trial involving 884 patients that assessed the safety and effectiveness of PillCam COLON in detecting adenomas at least six millimeters in size.
Results from this clinical trial demonstrated 88% sensitivity and 82% specificity. A separate analysis of the same data that used a more restrictive methodology indicated the positive percent agreement for PillCam COLON and optical colonoscopy was 69%, and negative percent agreement was 81% for polyps at least six millimeters in size.
PillCam COLON is currently commercially available in more than eighty markets including Japan, Europe, Latin America, Canada, Australia and parts of Asia and Africa.