The PillCam has been revved up to speed diagnostics and broaden its uses among gastroenterologists.
Introduced by Israel-based Given Imaging, the pill-sized device includes a miniature video camera that is swallowed by a patient and then returned to a physician after it passes through their gastrointestinal system. During its journey through the small bowel, the device takes 15 to 25 picture frames a second — about 55,000 altogether — which can be downloaded later and reviewed by the physician to diagnose abnormalities like Crohn's disease, Celiac disease and tumors. The PillCam was approved for use in the U.S. by the Food and Drug Administration as an "adjunctive" tool in 2001 and OK'd for primary diagnosis use in 2003.
And it's been catching on around the country. In May, Given Imaging reported that record PillCam sales helped push revenue up 73 percent in the first quarter of this year, to $22 million.
In a recent clinical trial involving 24 patients, the PillCam's wireless capsule endoscopy was compared with barium contrasts to find polyps in the small intestines. In barium contrasts, a doctor orders X-rays after a reflecting liquid is inserted into the small intestine.
Researchers found that the barium contrasts were able to locate polyps in three of the patients, while the pill camera was used to find polyps in seven.
"Our study confirms previous study findings that established the accuracy of innovative wireless capsule technology in identifying intestinal polyps," said Josep Llach, MD, lead study author from the Endoscopy Unit of the University of Barcelona in Spain. "This non-invasive procedure is legitimately setting a new standard for small bowel assessment."
The newer devices have a "much quicker download time," says Dr. Asher Kornbluth, a specialist and associate clinical professor of medicine at Mt. Sinai School of Medicine who's been beta testing the souped up devices in his practice. While he had been required to look at one image at a time in the older generation PillCam, the newer version lets him look at four.
"We want to make sure that just because it's faster," says Dr. Kornbluth, "it's not missing any lesions." And so far. he's been satisfied that the faster speed hasn't detracted from the quality of his diagnosis.
The PillCam can be used to detect obscure bleeding and additional information that could help in diagnosing the extent and activity of Crohn's disease, says Dr. Kornbluth, who first started using the device three years ago.
And the updated version is working according to promise, he says. The old technology would miss 20 percent of the lesions he was sleuthing for.
The procedure is a simple one, he explains. Patients are given the PillCam at 8 a.m., which they swallow with a glass of water. Over the next 8 hours, images are picked up by various sensors on the body and sent to a datarecording device worn on the patient's belt. They return to the doctor's office at 4 p.m., when the one-time device passes through the patient's system and is retrieved. Taking anywhere from 30 to 60 minutes, the doctor reads the images on a proprietary software system provided by Given Imaging.
Dr. Kornbluth says he's typically reimbursed anywhere from $900 to $1,500 per procedure, which he does from 100 to 150 times a year.
The PillCam plays an important assisting role in diagnosing a case and giving the doctor the kind of information needed to settle on a treatment, says Dr. Kornbluth. There are, he adds, a wide variety of responses to Crohn's disease.
But Given Imaging believes that new research has provided sufficient data to show that the PillCam can be used as a first-line test, without the need for any other endoscopy techniques.
And the company has been making headway.
Last May, Humana became the first insurer to reimburse for the use of the PillCam as a first-line diagnostic tool in suspected Crohn's patients who had failed small bowel follow-through. And a new PillCam is in clinical trials as an esophageal diagnostic tool.