EnteroMedics Inc. said Monday that the Food & Drug Administration approved a new clinical trial for its Maestro anti-obesity device that uses electricity to suppress hunger.
The news represents a major victory for the Roseville, Minn.-based company, whose previous study ended in failure. Last October, initial results from the "Empower" studies of more than 400 patients showed people who used the Maestro device lost just as much weight as patients implanted with the dummy device.
In a previous interview, CEO Mark Knudson said wires from the placebo device, which were connected to a nerve, released low intensity energy whenever the company performed a safety check on the device. While the Maestro device delivered 10,000 times more electricity to the therapy group, it did not perform any better than the control group’s dummy device.
Since January, the company has been negotiating with the FDA on a study through the agency’s Investigational Device Exemption program.
The new 12-month study, dubbed ReCharge, will enroll 234 morbidly obese people who will randomly be implanted with Maestro or a sham device. This time, the dummy device will have no wires connected to the nervous system. Patients will also use an updated Maestro device in which the battery pack will be worn around the belt instead of implanted.
The company hopes patients with Maestro will lose 20 percent more weight than people implanted with the dummy device. The trial will begin the second half of 2011.
