US regulators have approved a novel dieting device that acts like a pacemaker for the stomach by manipulating the nerve pathway that makes people feel hungry or full.
The Wall Street Journal reports that the device, made by EnteroMedics in St Paul, Minnesota, is the first of its kind to treat obesity by targeting nerves that link the stomach and the brain. The Maestro Rechargeable System would block electrical signals in the abdominal vagus nerve by dispatching high-frequency electrical pulses. A Food and Drug Administration advisory panel concluded the Maestro system showed a sustained weight loss in patients even though it fell short of its goal.
The device is one of a series of products called neuro-modulators that target nerves for a variety of conditions ranging from pain to Parkinson’s disease. It is intended for people with significant obesity and at least one other related condition. These other maladies could include Type 2 diabetes or high blood pressure.
The device is implanted surgically into the abdomen, and is designed to be used in people age 18 and over who haven’t been able to shed pounds with a weight-loss program. It is to be used in people with a body-mass index of 35 to 45, or roughly 75 pounds or more over a person’s ideal body weight.
In a 233-patient clinical study of the device, the Maestro system didn't meet the original goal, or endpoint, of the research after 12 months. That goal was for device patients to lose 10% more excess weight than the control group, or patients who had the device implanted but not turned on. However, the 157 patients with the working device lost 8.5% more of their excess body weight than did the control group.
The FDA said about half, or 52.5%, of the patients getting the treatment lost at least 20% of their excess weight, and that 38.3% lost at least 25% of excess weight. William Maisel, chief scientist in the FDA's centre for devices, noted that obesity is a major public-health concern and that devices "can help physicians and patients to develop comprehensive obesity treatment plans."
The manufacturer will be required to conduct a five-year, post-approval study in which at least 100 patients will need to be followed. Researchers will collect further data about weight loss, adverse events, surgical revisions and the need to have the device taken out. In the study already done, adverse events included nausea, pain, vomiting and surgical complications. The company said the rate of severe adverse events through 12 months of implant was 3.7%.
[link url="http://www.wsj.com/articles/fda-approves-new-obesity-device-1421276434?utm_source=nextdraft&utm_medium=email"]Full report in The Wall Street Journal[/link]