EnteroMedics Inc on Wednesday won approval from the US Food and Drug Administration (FDA) for its new device to treat obesity, the first since 2007, sending the company’s share up as much as 74 percent.
The new obesity treating device is known as the Maestro Rechargeable System. According to the makers, the device helps the people facing weight problem in controlling their hunger and gives them a feeling of fullness.
According to the developers, the new obesity controlling system helps the obese in people in checking their calories intake by targeting the nerve pathway between the stomach and brain.
The researchers at the company further explain that the device is implanted into the abdomen surgically, from where it sends electrical pulses that further interferes with the working of the vagus nerve, responsible for sending signals to the brain about the stomach’s hunger.
The Maestro Rechargeable System is rechargeable by both patient and medical professionals. Besides, the settings of the device can also be done using external controllers.
The company got the green signal from the FDA after a 12-month clinical study that showed patients with the device implanted inside their abdomen lost 8.5 percent more weight than those under the control group.
The federal body has given approval to the company for the use of device in patients aged 18 and older, who have failed to lose weight with a weight-loss program and have a body mass index of 35 to 45. The user also requires at least one other obesity-related condition, like Type II diabetes.
According to the FDA, the company is required to further conduct a five-year research work involving at least 100 patients and also collect additional effectiveness and safety data for the device.
Some of the serious side effects found during the clinical study are: pain, nausea, vomiting and few surgical complications.
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