FDA approves Maestro Rechargeable System to treat Obesity- EnteroMedics
The FDA on 14 January 2015 approved the Maestro Rechargeable System, a vagal blocking therapy, from EnteroMedics for certain Obese adults, 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 Maestro Rechargeable System, the first FDA-approved Obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss programme, and who have a body mass index of of at least 40 to 45 kg/m2, with at least one other obesity-related condition, such as type 2 diabetes.
Comment:The Maestro Rechargeable System consists of a rechargeable electrical pulse generator with wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signalling to the brain that the stomach feels empty or full. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.
The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
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