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  • FDA Approves Electronic Stimulation Device as Obesity Treatment

    The US Food and Drug Administration (FDA) has approved a first-of-its-kind weight loss device the uses surgically implanted electrodes to block nerve activity between the stomach and brain.

    Called the Maestro Rechargeable System, the new device uses a rechargeable electronic pulse generator that sends intermittent pulses to the trunks of the nerves responsible for signaling whether the stomach feels empty or full. According to an FDA news release, although it's clear that the impulses block nerve activity, "the specific mechanisms for weight loss due to use of the device are unknown."

    The system was evaluated in a clinical trial of 233 patients with a BMI of 35 or more that recorded weight loss of 8.5% more than a control group after 12 months. According to the FDA, just over half of the participants in the experimental group lost at least 20% of their excess weight.

    The Maestro system is approved to treat patients 18 and older who have not been able to lose weight through a weight-loss program, and who have a BMI of 35 to 45 with at least 1 other obesity-related condition. It is the first obesity treatment device approved by the FDA since 2007.

    EnteroMedics, the manufacturer of the Maestro system, agreed to conduct a 5-year study on the device as a condition of FDA approval.

    Comments

    • I'm glad the FDA has approved this, although I'm skeptical - 233 patients is a pretty low n, and 20% of their EXCESS weight doesn't actually seem like all that much (unless they are morbidly obese). I'm not a statistician, but 8.5% must have been just barely statistically significant. All the same, something is better than nothing, and if it gives people hope and another avenue towards weight loss, then more power to it!

      Posted by Jeff Harband on 1/16/2015 6:05 PM

    • I agree with the skepticism on the numbers reported for this study. However, it seems less invasive and health depleting than a lap band or removal of digestive organs.

      Posted by Julia Anderson on 1/20/2015 9:18 PM

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