Enteromedics Developing New Approach to Treat Obesity
A new device, the Maestro RF2, which is touted as an alternative approach to gastric bypass is under development by researchers from Enteromedics. The system entails vagal blocking therapy (VBLOC). A team representing the company presented data at a recent neurotechnology conference in Boston.
The company is proposing use of an implantable device that blocks activity of the vagus nerve with electrical signals. The vagus nerve is targeted because it regulates hormones related to eating and links the digestive system with the brain, as well as controlling other factors linked with satiety and hunger.
Two small electrodes are implanted laparoscopically at the top of the stomach adjacent to the vagus nerve. A regulator is also implanted under the skin which emits high-frequency electrical pulses to the electrodes. It is suggested that the pulses block signals emanating from the vagus nerve, though the exact mechanism of action has yet to be delineated.
Early human trials indicate that the Maestro RF2 may slow down digestion. Patients who have had the device implanted report that they feel more full earlier and are less hungry. Among the first nine patients who had the Enteromedics’s device implanted, all lost nearly thirty percent of their excess weight after nine months of treatment. Data from a successive, larger group of patients shows that patients ate 500 calories less on a daily basis after device implantation.
None of the patients participating in the studies thus far, over 100 in total, have experienced any serious adverse events, including death. The company has yet to report on the occurrence of less serious incidents.
The company commenced a placebo-controlled trial intended to recruit 300 patients, the EMPOWER study, that is underway in Australia and the U.S. All patients will have the Maestro RF2 device implanted, but one third of the patients will have an inactive device during the first few months of the study.
There is a significant market for approaches other than gastric bypass to treat a growing population that suffers from obesity. Eligibility for gastric bypass is strict and many patients who are simply obese, rather than morbidly obese, are not eligible because they are not heavy enough. As well, gastric bypass surgey carries significant risks, which are deal breakers for some patients.
A number of other devices are under development, some stimulate the vagus nerve; the opposite approach to the Enteromedics’s system. Other examples include tools to alter gastric motility processing, updated lap bands, and devices designed to minimize the available space in the duodenum as reported by the Technology Review.
May 21, 2008 Related topics: New Technology & Innovation, Bariatrics & Obesity