Enteromedics is a company that using electrical impulses to control physiologic function in humans. It developed the Maestro System, which limit the expansion of the stomach, control hunger sensations between meals, reduce the frequency and intensity of stomach contractions, and produce a feeling of early and prolonged fullness. It works on an implantable electrical stimulator and recently has been evaluated by the FDA.
This is the result of the conference by the FDA panel: 1. That benefit outweighs risk: 6 yes, 2 no, 1 abstain. 2. On safety, the vote was 8 yes, 1 no. 3. On efficacy the vote was 4 yes, 5 no. Yet the vote earlier in the day on whether the 18 month data supported efficacy was 9 yes, 0 no.
Scientific consensus.
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