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ReCharge Study

ReCharge Study: vBloc Therapy shows 34% EWL

Participants were randomised at implant in a 2 : 1 ratio to vBloc and Sham control arms in permuted block sizes of 3 or 6 stratified by clinical site and type 2 diabetes mellitus status.

Analyses of the ReCharge Study demonstrated excess weight loss (EWL) of 34% and significant improvements in obesity-related risk factors for vBloc Therapy treated, moderately obese patients who had at least one comorbidity. The data were presented at the International Federation for the Surgery of Obesity and Metabolic Diseases 20th World Congress in Vienna, Austria in August.

Scott Shikora

"These subgroup analyses of the ReCharge Study, which demonstrated excess weight loss of 34% and major improvements in obesity related risk factors, show the profound and clinically meaningful effect of vBloc Therapy in patients with a Body Mass Index (BMI) of 35-40 kg/m2," said Dr Scott Shikora, EnteroMedics Executive Vice President and Chief Medical Officer, "These results show significant benefits as it relates to weight loss and relief of comorbidities and improved safety relative to anatomy altering and restrictive procedures, making vBloc an attractive alternative for those patients unwilling to undergo more drastic procedures to regain their health."

The ReCharge trial is a five-year, double-blind, Sham-controlled trial comparing vBloc to an implanted Sham device. Participants were randomised at implant in a 2 : 1 ratio to vBloc and Sham control arms in permuted block sizes of 3 or 6 stratified by clinical site and type 2 diabetes mellitus status.

Implant of the vBloc device and electrodes requires standard laparoscopic surgery performed under general anaesthesia. Electrodes are placed around the anterior and posterior vagal nerve trunks near the gastroesophageal junction, secured with sutures and connected to a rechargeable neuroregulator placed in a subcutaneous pocket on the thoracic side wall. The neuroregulator is recharged transcutaneously with a transmit coil placed over the neuroregulator connected to a mobile charger.

Participants randomised to the Sham arm were implanted with a similar neuroregulator that dissipated charge at a rate similar to the active device into a resistor within the Sham neuroregulator. Electrodes were not implanted and the vagal nerve trunks were not manipulated. To support the blind, Sham patients had the same number of skin incisions to simulate a laparoscopic procedure, but without entering the abdominal cavity. Active and Sham neuroregulators were sized identically at 8.6cm in diameter, 7.1cm in width, and 1.6cm thick.

The neuroregulators in both groups were programmed to deliver therapy for at least 12 hours per day (though no therapy was delivered in the Sham group). Therapy energy levels were increased over the first month to the desired amplitude of 6 mA, although the amplitude could be adjusted by the follow-up team if the participant felt uncomfortable therapy-related sensations at any time during the trial. All monthly visits were collected within a ±2 week window.

All participants were asked to check their battery level daily and to recharge their battery approximately twice weekly. Follow-up visits occurred weekly in the first month, biweekly through month three, and monthly thereafter through the second year. All participants participated in a weight management program that coincided with clinic visits. The weight management program typically consisted of a 15-minute educational interaction discussing healthy food choices, physical fitness, and social support. No specific diet (e.g., portion-controlled meals) or exercise programme was prescribed.

The study examining 12-month primary efficacy and safety endpoints of the study have been previously reported. Efficacy and safety continue to be assessed for five years. This report focuses on efficacy and safety at 18 months. Related serious adverse events, as defined in the previous publication, through 18 months were classified according to the Clavien-Dindo classification of surgical complications.

The trial includes 239 with a BMI40-45 or 35-40 with at least one obesity-related condition(s).  These analyses of the ReCharge Study evaluated the efficacy, safety and comorbidity impact of vBloc Therapy (n=53) and sham (n=31) on patients with moderate obesity (BMI 35-40) and one or more comorbidities.

Mean EWL at 12 months in the per-protocol group (defined as subjects with 12 month data, correct treatment randomisation who received treatment within 45 days of implant) was 34+26% (95% CI, 26 to 41) in vBloc group and 19+18% (95% CI, 12 to 27) in sham group. Some 87% of the subjects remained in both groups at the end of the 12 months. No serious device-related complications were observed in the first year.

EnteroMedics' Maestro Rechargeable System has received FDA, CE Mark and is listed on the Australian Register of Therapeutic Goods.

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