FDA expands indication of PillCam COLON 2 for detection of polyps in patients at risk of GI bleed- Medtronic

The FDA has cleared PillCam COLON 2 capsule, from Medtronic, for an expanded indication for use. This expanded indication is for the detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower gastrointestinal (Gl) origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

The PillCam COLON 2 capsule is the only non-invasive diagnostic test that directly visualizes the colon for the evaluation of polyps in patients who are at major risks for colonoscopy or moderate sedation. The PillCam capsule- a vitamin-sized capsule endoscope that is taken orally - does not require sedation, anesthesia or radiation, which makes it a more convenient procedure than other invasive colon exams.

Comment: The PillCam COLON 2 capsule was previously cleared by the FDA for visualization of the colon and the detection of colon polyps in patients following an incomplete colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. The PillCam capsule technology may also limit the risk of complications that could occur from a standard colonoscopy, such as colon perforation, bleeding or cardio-pulmonary complications.