(The GERD patient population is a largely untapped surgical market; see chart entitled, “Total Potential Market for Endoscopic GERD Therapies”)
Physicians from UT Southwestern Medical Center and engineers from UT Arlington have collaborated to develop a new technology for detecting the occurrence of heartburn and gastroesophageal reflux disease (GERD). Presented in May at the Digestive Disease Week conference in Washington, DC, the new system involves the use of a small chip designed to replace current standard testing procedures, which can cause patient discomfort and impact normal eating habits.
The new wireless system uses radio frequency identification technology (RFID), which is being utilized in many industries for tracking inventory. To create the new device, RFID technology was paired with impedance monitoring.
To monitor the esophageal environment, a small, flexible RFID chip is pinned to the esophagus. The chip utilizes a special plastic material intended to prevent patients from feeling it in their throats. Measuring roughly two square centimeters, the device monitors electrical impulses of liquids moving through the esophagus, and whether they are acidic or nonacidic. The chip collects the data and sends it to a wireless receiver worn around the neck. As patients go about their normal daily lives, the chip will monitor the presence of acid, gas, or water, after which physicians review the data to determine if the patientâ€™s heartburn symptoms coincide with eating a meal or other activities.
Researchers have tested the device in the lab to ensure it accurately identifies the acidity of substances and can send results through human tissue. The next step will involve testing in animal models. It has taken roughly two years to develop the wireless RFID system and enable it to detect and send data. The receiver will include a button that the patient can push when they begin eating. Eventually, the engineers hope to design a device similar to a PDA to store the collected data. This would then be downloaded for analysis at the doctorâ€™s office.
New monitoring methods for GERD are sorely needed to replace current methods, which require placing a flexible catheter tube through the nose and down into the esophagus. The procedure is very uncomfortable and, because the presence of the catheter usually necessitates a change in the way a patient would normally eat and drink, it can produce biased test results. Since no catheter is required with the RFID system, doctors are hopeful that it will make it easier for patients to eat and drink as they would normally and maintain their usual activity levels.
Several other technologies have been developed in recent years that provide a noninvasive alternative for gastrointestinal diseases. These include the PillCam, a small pill-sized wireless camera that snaps photos during its journey through the digestive tract, and the Bravo capsule, another wireless system that detects esophageal acids. Both of these are both also used by UT Southwestern gastroenterologists.
GERD can occur in adults, children and infants; as many as 10% of Americans experience heartburn on a daily basis, and it is estimated that GERD affects 25%â€“35% of the population. Current diagnostic methods include barium swallow, endoscopic manometry, and pH testing. Treatments include lifestyle modification, antacids, proton pump inhibitors, positional therapy and surgery. Complications of GERD are common, including esophagitis and Barrettâ€™s esophagus, a potentially precancerous stage of disease.
For details on the market for devices to treat GERD, see â€œCurrent Status of Endoscopic Surgical Therapies for GERD,â€ (June 2007 MedMarkets; http://mediligence.com/web-files/archive2007.html).