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The Food and Drug Administration (FDA) has approved vagal blocking therapy, (EnteroMedics' VBLOC ) which is the first weight loss-treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
The System is made up of a rechargeable electrical pulse generator (Maestro Rechargeable System), wire leads, and electrodes that are surgically implanted into the abdomen. With the VBLOC Therapy, electrical pulses are sent to the trunks in the abdominal vagus nerve, which plays a role in stomach emptying and sending signals to the brain that the stomach feels empty or full.
The device can be recharged by the patient and the setting can be adjusted by healthcare professionals using external controllers. A 12-month clinical study showed that patients implanted with the device lost 8.5 percent more weight than the control group. Though it did not meet the main goal of 10 %, 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 or high cholesterol or high blood pressure. (BMI 30 above is considered as Obese)
Serious side effects reported in the clinical study included nausea, pain, vomiting and surgical complications. According to the Centers for Disease Control and Prevention (CDC), more than one-third of U.S. adults are obese placing them at greater risk of heart disease, stroke, diabetes and cancer. But the main question remaining is who will pay for this device. The price of the device is not revealed. Also none of the insurance companies has come forward to bear the cost.
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