FDA approves EnteroMedics' medical device to treat obesityReprints
(Reuters) — The Food and Drug Administration said on Wednesday it has approved a new device to treat obesity, the first since 2007, sending shares of its maker, EnteroMedics Inc., up as much as 74%.
Known as the Maestro Rechargeable System, the device controls hunger and feelings of fullness by targeting the nerve pathway between the brain and the stomach.
It is implanted surgically into the abdomen and works by sending electrical pulses that interfere with the activity of the vagus nerve, which signals to the brain that the stomach is empty.
The device can be recharged by the patient, and healthcare professionals can adjust its settings using external controllers.
A 12-month clinical study showed that patients implanted with the device lost 8.5% more weight than the control group.
That did not meet the main goal of the clinical trial, which was to show weight loss of 10% or more. But an FDA advisory panel considered additional data and concluded that the benefits of the device outweighed the risks for certain patients.
The device is approved to treat patients aged 18 and older who have not been able to lose weight with a weight-loss program, who have a body mass index of 35 to 45 and have at least one other obesity-related condition, such as Type II diabetes. A person with a BMI of 30 or more is considered obese.
Despite the approval, the prospects for the device will depend on insurers being willing to pay for it, a process that could take up to two years, analysts estimate.
As part of the approval, the company must conduct a five-year study that will follow at least 100 patients and collect additional safety and effectiveness data.
Serious side effects reported in the clinical study included nausea, pain, vomiting and surgical complications.
More than a third of U.S. adults are obese, according to the Centers for Disease Control and Prevention, placing them at greater risk of heart disease, stroke, diabetes and cancer.
Other surgical treatments for obesity include gastric banding systems that limit the amount of food that can be eaten at one time.