The FDA's Gastroenterology and Urology Devices Panel votes 8:1 in favor of the safety of EnteroMedics' (ETRM) Maestro VBLOC Therapy system for the treatment of obesity, but votes 4:5 on the issue of reasonable assurance of efficacy. The final vote, however, was 6:2 recommending approval with one abstention. The FDA usually follows the majority of an Ad Comm vote.
The Maestro is a pacemaker-like device that delivers VBLOC therapy which controls the hunger sensation and sense of fullness by blocking the primary (Vagus) nerve that regulates the digestive system.
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