FDA gives Medtronic's PillCam OK for expanded indication on major risk patients

Medtronic's PillCam--Courtesy of Given Imaging

The FDA has cleared Medtronic's ($MDT) PillCam COLON 2 ingestible capsule for an expanded indication in patients who are at major risks for colonoscopy or moderate sedation.

The regulatory agency's expanded indication of the device is for the detection of colon polyps in patients with a history of gastrointestinal bleeding of lower gastrointestinal origin, the company said in a release. The new indication is targeted only at patients with major risks for colonoscopy or moderate sedation, but who can handle a colonoscopy and moderate sedation in the event a major abnormality is found by the capsule endoscopy.

The device is about the size of a vitamin and is swallowed by the patient without the need of sedation, anesthesia or radiation.

"The new indication allows gastroenterologists to provide their at-risk patients with a non-invasive and radiation-free alternative to traditional colonoscopy," Dr. Douglas Rex, director of endoscopy at the Indiana University School of Medicine, said in a statement.

Colon cancer is the second leading cause of cancer death in the U.S. among men and women combined with an estimated 136,000 people in the country diagnosed with colorectal cancer each year. When diagnosed at a localized stage, the overall 5-year survival rate is 90%, according to studies cited by Medtronic.

The PillCam COLON 2 device 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. Of the 14 million colonoscopies performed in the U.S. every year, more than 3 million of those procedures are done for lower gastrointestinal bleeding with about 600,000 of the procedures done on patients who are at an elevated risk for complications.

Though Medtronic has dominated the arena of ingestible endoscopic imaging capsules the competition has begun to heat up. Earlier this week, California-based Rock West Medical Devices raised $1.25 million in equity to advance its MoPill, an ingestible capsule that measures the motility--spontaneous and active movement--of the gastrointestinal tract.

Additionally, MIT researchers are developing a capsule that measures heart and respiratory rates in real time. And a University of Glasgow team is working on a capsule that images with nonvisible light and could be used to diagnose gastrointestinal cancers.

- here's the Medtronic release

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