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Over two-thirds of adults in the United States are considered obese. To help combat this epidemic, the FDA made a bold statement by approving a new, pacemaker-like device has been approved by the FDA for weight loss purposes. How does it work? Let’s get down to specifics.
The FDA is notoriously stingy with its approval status, only approving four medications over the last handful of years. The agency is even stricter with weight loss devices, making this one (the EnteroMedics Maestro system) the first approval of its kind since 2007. The trick to this device is how it blocks your brain from being hungry — by manipulating signals between your brain and stomach — through vagal blocking therapy, or VBLOC.
How: The device must be surgically implanted above the stomach in order to properly suppress the vagus nerve from carrying signals. The Maestro provides quick bursts of electrical current (every five minutes or so), which keep the stomach from relaxing and demanding to be fed. The device also smartly powers down while a patient sleeps, so that the vagus nerve’s gut signals don’t completely shut down. If that happened, the brain would figure out how to compensate, which would negate the device’s effectiveness. Crafty, right? The device is intended to be permanent, which will hopefully result in lifelong weight loss. Yet if a patient chooses to remove or deactivate the implant (such as during pregnancy), there will be no long-lasting effects.
Who: Not everyone is eligible for this device. The FDA has only approved use in patients with a BMI between 35 and 45. Patients must also suffer from a comorbid condition such as diabetes to qualify. Physicians are still free to prescribe the device for any patient they think will benefit from the implant, especially those who must lose some weight before qualifying for gastric bypass surgery.
Cost: The Maestro is projected to cost between $20-25,000 dollars, which is comparable to gastric bypass with far fewer side effects. Insurers haven’t jumped on the bandwagon just yet. The company hopes to jump the Medicare hurdle by late 2015.