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December 3, 2013
08:57 EDTETRMEnteroMedics announces 18 month results from ReCharge study
EnteroMedics announced 18 month efficacy and safety results from its 5 year ReCharge Pivotal Trial of VBLOC vagal blocking therapy for the treatment of obesity. Patients in the VBLOC group achieved excess weight loss of 25%, or 10% total body weight loss, compared to 12% EWL, or 4% TBL for sham control group patients. The 13% difference in EWL demonstrated statistical superiority over sham control. In total, 54% of patients in the VBLOC group achieved at least 20% EWL and 41% achieved at least 25% EWL, compared to 26% and 17%, respectively, for the sham control group at the 18-month interval. Significantly, approximately 78% of the patients who reported for their 18-month visit remained under the clinical trial's randomized blind. The rate of device-related serious adverse events at 18 months was 4.3% for the VBLOC group, meaningfully lower than the 12 month threshold of 15%. The safety results continued to confirm VBLOC Therapy had no adverse cardiovascular effects. Overall, a reduction in blood pressure and heart rate was observed.
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