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FDA Expands Indication for PillCam Colon 2 Capsule
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The FDA has expanded the indication for the PillCam Colon 2 capsule to include detection of colon polyps in patients with evidence of lower GI bleeding, according to a press release from the manufacturer.
“The ability to offer PillCam Colon capsule to an expanded patient group represents a significant breakthrough in GI healthcare,” Douglas K. Rex, MD, director of endoscopy at Indiana University School of Medicine, said in the press release. “The new indication allows gastroenterologists to provide their at-risk patients with a non-invasive and radiation-free alternative to traditional colonoscopy.”
Douglas K. Rex
The PillCam Colon 2 capsule (Medtronic) is a vitamin-sized capsule endoscope that is swallowed and then visualizes the colon to evaluate polyps in patients with major risks for colonoscopy or moderate sedation, according to the press release. It does not require sedation, anesthesia or radiation.
The expanded indication “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.” Six hundred thousand patients who undergo colonoscopy in the U.S. annually are at elevated risk for complications, according to the press release. Potential complications from a standard colonoscopy include colon perforation, bleeding and cardio-pulmonary complications.
The FDA previously approved the PillCam Colon 2 capsule for visualization of the colon and the detection of colon polyps in patients for whom a complete evaluation of the colon was not technically possible after an incomplete colonoscopy with adequate preparation.
Disclosure: Rex is a paid consultant for Medtronic.