Despite his 20 years of experience, gastroenterologist Leonard Fischer, MD, says that many common functional disorders of the digestive system are difficult to diagnose and treat. That’s one reason Fischer’s five-physician practice recently made a $15,000 investment in digestible medical device technology that can aid in the diagnose of motility disorders, such as reflux disorders or irritable bowel syndrome.
Manufactured by Buffalo-based SmartPill Corp., the digestible device and its accompanying technology were approved by the Food and Drug Administration in 2006. Fischer’s practice, Gastrointestinal Medicine Associates in Fairfax, VA, began using the “smart pill” this past May. A patient swallows the pill, a vitamin-size device encased in plastic. Then the patient returns home wearing a data receiver on a belt clip or lanyard. As the pill works its way through the digestive system, it transmits data to the receiver. The device measures pH, which encompasses acidity, temperature and pressure, Fischer explains. The patient returns to the physician office a few days later, at which point the data is downloaded from the receiver. Fischer can then tell whether the device has been excreted from the body. If not, the patient will return in a couple of days.
Once the single-use device has passed through the body, the technology provides Fischer a continuous graph over time of the various clinical indicators. The system also produces a one-page report that summarizes the findings, including an analysis of the muscle contractions that took place during the study. By reviewing the data, Fischer can tell how long it took the pill to work its way through the digestive tract, beginning with the stomach and proceeding through the intestines. The patient keeps a diary of activities or complaints, which Fischer can compare to the smart pill readout. “If there was abdominal pain, we can see if there were abnormal contractions,” he explains.
Fischer says the technology may supplant gastric-emptying scintigraphy as the diagnostic tool of choice of functional disorders. In that procedure, the patients ingest radioisotopes, then lay on their back for two hours while radiologists monitor them, trying to assess the emptying time of the stomach. “It is not as accurate and is inconvenient for the patient,” Fischer says.
Despite the smart pill’s promise, Fischer acknowledges that insurance reimbursement is uncertain. “We are taking some risk,” he says. “But I believe the technology can help my practice and patients.” —Gary Baldwin