Medtronic’s PillCam Receives FDA Clearance For High-Risk Patients

Ireland-based Medtronic has gained additional US Food and Drug Administration (FDA) approval for their PillCam COLON 2 ingestible capsule. The device has received an expanded indication for patients who are too high-risk to receive a colonoscopy under moderate sedation.

According to a press release issued by Medtronic, the non-invasive device can now be used to detect colon polyps in patients who have experienced gastrointestinal bleeding episodes. The expanded indication will allow the device to be used in patients facing major risks associated with colonoscopy, but who would be able to receive the procedure to confirm an abnormality identified with the PillCam.

About the size of a multivitamin, the PillCam is designed to be taken orally, without the need for anesthesia, sedation or radiation. According to Medtronic, the capsule is the only FDA-approved, non-invasive diagnostic available for the direct visualization of the colon.

“The ability to offer PillCam COLON capsule to an expanded patient group represents a significant breakthrough in GI healthcare,” said Dr. Douglas Rex, Director of Endoscopy, Indiana University Health University Hospital. “The new indication allows gastroenterologists to provide their at-risk patients with a non-invasive and radiation-free alternative to traditional colonoscopy.”

Approximately 136,000 men and women are diagnosed with colon cancer in the US each year. Though the disease is the second leading cause of cancer-related death in the country, early detection leads to a 90 percent 5-year survival rate among patients.

When the PillCam COLON 2 first received FDA approval, its only indication was for colon visualization after a colonoscopy had previously been attempted, but was not able to be completed. Approximately 14 million colonoscopies are performed in the US on an annual basis, with over three million used to investigate cases of lower gastrointestinal bleeding. Roughly 600,000 colonoscopies are performed on patients at an increased risk of complications.

Medtronic is currently the leader in ingestible endoscopic imaging devices, however new competitors are emerging. Rock West Medical Devices has raised $1.25 million to develop its MoPill, an ingestible pill capable of monitoring the movement – or motility – of the gastrointestinal tract.