FDA Approves New Device for Treating Obesity
FDA Approves New Device for Treating Obesity – EnteroMedics Inc has come up with a new device for treating obesity which has been approved by the US Food and Drug Administration (FDA).
The device is called Maestro Rechargeable System, and it helps control hunger and satiety by by targeting the nerve pathway between the brain and the stomach. The device needs to be surgically implanted in the abdomen and can be recharged by the patient. Health professionals can control the settings of the device using external controllers.
Though a 12-month clinical trial fell short of the required weight-loss of 10% or more, and resulted in only 8.5% weigh-loss, the FDA looked at other benefits and decided to approve the device.
Patients 18 and older, with a body mass index of 35 to 45, having at least one obesity-related condition, such as type 2 diabetes can use the device. As per FDA approval requirements, the company needs to follow at least 100 patients over 5 years and collect additional safety and effectiveness data.
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