Posts Tagged ‘EnteroMedics’

FDA Panel Recommends Approval of New Obesity Device

June 17th, 2014 is reporting that the Food and Drug Administration Advisory Panel today recommended approval of a new medical device from EnteroMedics, the Maestro Rechargeable System. The voting was somewhat mixed regarding the effectiveness of the device.

The Maestro Rechargeable System uses an electrical system called V-Bloc. V-Bloc delivers the electrical signal to the trunks of the vagus nerve, which sends hunger signals to the brain. The company states that the device decreases hunger pangs, digestive enzyme secretion and calorie absorption and increases the feeling of fullness. It would be offered to candidates for bariatric surgery who do not want the full surgical intervention.

The company’s press release notes, “In the most recent clinical trial, the ReCharge Study, VBLOC Therapy treated patients demonstrated a clinically meaningful and statistically significant excess weight loss (EWL) at 12 months of 24.4%, sustained out to 18 months. The majority (52.5%) lost 20% or more of their excess weight and nearly one-third of VBLOC Therapy treated patients lost 30% or more. The 24.4% average EWL far exceeds the 10% to 15% thresholds at which patients experience substantial positive health effects. Statistically significant improvements were observed in the VBLOC Therapy treatment group in total cholesterol, LDL, triglycerides, systolic and diastolic blood pressure, heart rate and waist circumference.”

The approval by the panel is likely to encourage a number of other developers of advanced technological strategies to treat obesity. More.