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Swallowable imaging capsules not widely used

Twelve years ago, many health journalists, myself included, wrote excitedly about a new imaging capsule that could be swallowed and used to capture pictures of the intestines and colon. It didn’t require any sedation and might soon replace endoscopies to look for ulcers and colonoscopies to screen for colon cancer.

But that hasn’t panned out, and I haven’t heard much about the imaging capsule — called PillCam — until last week when I received an e-mail from Israeli manufacturer Given Imaging announcing a new and improved version of their device with better resolution and other upgrades.

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The PillCam and two imaging capsules made by other manufacturers are approved by the US Food and Drug Administration to evaluate lesions, ulcers, tumors, and bleeding within the small intestine in people having gastrointestinal symptoms. But none of these devices is used to screen for colon cancer, though that may come if the FDA approves an experimental capsule that Given Imaging has been testing in clinical trials.

“When PillCam was first approved in 2001, it got a lot of attention, but I was only person using it in this area for the first 18 months,” said Dr. David Cave, a gastroenterologist at University of Massachusetts Memorial Center. “Everyone thought I was crazy.”

Cave accepted funding from Given Imaging to perform research on the capsule but currently has no financial dealings with the company.

Patients swallow the pill — about the size of an antihistamine capsule — and strap on a cellphone device to their waist. As the pill winds its way through their small intestines over about four hours, the device transmits images to their doctor; within a day, the pill gets excreted and flushed.

Cave has used the capsule in about 5,000 patients over the past decade and finds it useful to evaluate the 15 to 20 feet of the small intestine that can’t be reached with an endoscope.

“Most academic centers are now using it,” Cave said, “as well as a lot of private gastroenterology practices. It’s become pretty widespread.”

But it hasn’t replaced the routine use of endoscopy to evaluate heartburn symptoms or check for signs of an ulcer.

That’s likely because insurance companies won’t reimburse for the imaging capsule procedure unless it’s performed after an endoscopy fails to find the source of the problem, Cave said.

Because the pill imaging costs about the same as endoscopy — typically $1,200, which includes the $500 imaging capsule — insurance companies figure they’ll come out ahead if endoscopies are performed first. Unlike with an endoscopy, doctors can’t insert tools to remove lesions for biopsy or cauterize areas that are bleeding, so if the imaging capsule finds something, another procedure would be needed to treat it.

Despite these disadvantages, Cave said he’d prefer to use the imaging capsule first, if he could, because it “produces beautiful photos in a non-invasive way” and doesn’t carry the same risks of endoscopy like life-threatening allergic reactions to the sedatives or perforation of the intestine, which can occur in rare cases.

Given Imaging said in a statement that two economic outcomes studies conducted by outside academic researchers found that the PillCam was cost-effective for insurers. The company added that the imaging device “may result in additional cost savings due to the reduction in physician resources and facility costs permitted by the outpatient nature of the PillCam SB [small bowel] capsule . . . and the potential for earlier diagnosis of disorders.”

If Given’s PillCam Colon gets approved by the FDA to image the colon — it’s already being used in Europe — it will probably be used as a first-line colon cancer screening option only if insurance companies decide to cover it.

“It will likely cost the same as a colonoscopy and will also require a repeat procedure if a polyp is found,” Cave said. It also would require the same prep as a colonoscopy to clean out the colon — requiring the use of strong laxatives the night before. Both of these things have hindered the use of virtual colonoscopies, which use CT scans to image the colon, over standard colonoscopies.

The imaging capsule, unlike the CT scans, doesn’t deliver radiation, so that could be a selling point to doctors and patients over virtual colonoscopies.

“In Massachusetts, only about 50 to 60 percent of eligible people have screening colonoscopies so that leaves a lot of people who aren’t being screened,” Cave said. “Perhaps some of them would be willing to undergo screening if they had a colon capsule.”

Deborah Kotz can be reached at dkotz@globe.com. Follow her on Twitter @debkotz2.
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