The first weight-loss device to gain U.S. regulatory approval in eight years is made by a Roseville company.
The Food and Drug Administration announced Wednesday it has approved the Maestro Rechargeable System for use by certain patients fighting obesity.
The maker of the device, EnteroMedics, says it is surgically implanted – much like a pacemaker – and stimulates the nerve that runs between the stomach and the brain, sending signals about how hungry or full the patient feels.
The FDA approved the device for patients who are 18 or older, have a body mass index of 35 to 45, and have been unable to shed pounds in a supervised weight management program during the previous five years. They also must have another health-related condition such as diabetes, high blood pressure, or high cholesterol.
The Maestro device has an external battery which needs to be recharged weekly, the Associated Press says.
Reuters reports that can be done by the patient, while a medical professional can adjust the device's settings with external controls.
An article from Middle East North Africa Financial Network notes this is only the third weight-loss device approved in the U.S. and it uses a different approach than the others, which limit how much food can fit in the stomach.
An obesity expert at The Mt. Sinai Hospital in New York says therapies like the Maestro system that alter the body's regulation of food intake are the wave of the future, the network reports.
Boost for EnteroMedics
The Star Tribune says the Maestro system is currently the only product made by EnteroMedics.
The company's stock price rose nearly 19 percent Wednesday on news of the FDA approval.
Bloomberg News reports the Maestro system still faces obstacles on the road to wider adoption, particularly since many insurance companies and government health programs have refused to cover weight-loss treatments.
A company executive tells Bloomberg the device is already approved in Europe and Australia but EnteroMedics plans to focus on its U.S. launch, targeting sales to surgical centers.