WASHINGTON -- A first-of-its-kind weight-loss device that uses electrode implants to trick the brain into thinking the stomach is full has won regulatory approval Wednesday in the U.S.
The Food and Drug Administration cleared the Maestro Rechargeable System, the first weight-loss device that targets the pathway between the brain and the stomach that controls feelings of hunger and fullness.
The device is only approved for patients 18 and older who, in the past five years, haven't been able to lose weight in a supervised weight-management program. Eligible patients must have a body mass index of 35 to 45 and at least one other related health condition like type 2 diabetes, high blood pressure or high cholesterol. The system also is the first obesity device approved in the U.S. since 2007, the FDA said in a statement.
EnteroMedics Inc., which has been publicly traded since 2007, soared nearly 19 percent to $1.40 a share in New York trading, bringing its market value to $96.7 million. The shares had declined 50 percent in the past year through Tuesday.
Products to help Americans lose weight have been a hot category in the last few years, though one that has had some trouble producing major revenue. The FDA has approved four weight-loss drugs since 2012, three pills and one injection.
St. Paul, Minnesota-based company's system uses electrodes implanted in the abdomen to send electrical pulses to nerves, the FDA said. Patients use external controllers to charge the device and allow doctors to adjust its settings.
How exactly the system helps people lose weight is unknown, the FDA said.
"Obesity and its related medical conditions are major public health problems," William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in the statement. "Medical devices can help physicians and patients to develop comprehensiveobesity treatment plans."
Serious adverse reactions included nausea, pain at the neuroregulator site, vomiting and surgical complications. Other side effects included heartburn, problems swallowing, belching and chest pain.
A clinical trial of the Maestro didn't achieve its primary objective of getting patients to lose 10 percent more excess weight than the control group, the FDA said. Still, an agency advisory panel found that data from the trial provided evidence of sustained weight loss and that the device's benefits outweighed its risks for some patients.
Even with the FDA ruling, the Maestro faces a tough road for wide adoption. Many insurers and government health programs have refused to cover weight-loss treatments since Belviq, from Arena Pharmaceuticals Inc. and Eisai Co., and Qsymia, by Vivus Inc., were approved in 2012.
A company executive said the device is already approved in Europe and Australia though it is not yet on sale. EnteroMedics plans to focus on the device's U.S. launch, targeting sales to surgical centers. The company is also pursuing reimbursement from health care insurance providers.
The Associated Press contributed to this report.
-- Bloomberg News