NEW YORK (TheStreet) -- EnteroMedics (ETRM) surged Wednesday after the medical device developer announced a Food and Drug Administration panel had voted positively on VBLOC vagal blocking therapy for obesity treatment.
The FDA's Advisory Gastroenterology and Urology Devices Panel, or GUDP, voted 8 to 1 in favor that the device is safe when used as designed and 4 to 5 "against" on the subject of reasonable assurance of efficacy. The final vote was 6 to 2 in favor, with one abstention, of VBLOC's benefits outweighing the risks.
The FDA does not have to follow the GUDP's recommendation, but it will factor it in when reviewing the Maestro System Premarket Approval (PMA). EnteroMedics expects a decision on PMA approval later this year.
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