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vBloc Therapy

Two-year vBloc Therapy outcomes published

vBloc Therapy demonstrates durable weight loss, reduction of comorbidities and favourable safety profile at 24 months

The 24 month results from the ReCharge Clinical Study, a five-year study that is comparing the vBloc Neurometabolic Therapy (EnteroMedics) to an implanted Sham device, has found that intermittent vagal blockade with vBloc therapy produces medically meaningful weight loss at two years, with a favourable safety profile and sustained improvements in obesity-related cardiovascular risk factors, healthy eating behaviours and quality of life.

"The ability to sustain meaningful weight loss is vital when considering a viable long term solution for treating obesity and its related comorbidities," said Dr Caroline M Apovian, Director, Nutrition and Weight Management, Professor of Medicine at Boston University School of Medicine, and lead author of the paper published in Obesity Surgery. "vBloc has consistently set itself apart, demonstrating sustained weight loss combined with a compelling safety profile. These findings underscore vBloc Therapy's potential to serve as a favourable, effective therapy in patients struggling with obesity who prefer not to undergo an anatomy-altering or lifestyle-restricting bariatric procedure."

In the paper, ‘Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial’, the researchers note that the ReCharge Pivotal Trial is a randomised, double-blind, sham-controlled, multi-centre pivotal clinical trial of vBloc Neurometabolic Therapy in 239 patients with obesity.

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.

At 24 months, 76% percent of the randomized vBloc participants (n=123) remained in the trial. The mean excess weight loss (EWL) among vBloc participants who presented for their 24-month visit was 21%, with a mean percent total weight loss (TWL) of 8%. Of the 24 Sham control patients who had not yet crossed over to vBloc at 24 months, the EWL and TWL was 4% and 1%, respectively.

The authors stated that comparative randomised controlled trials for conventional bariatric procedures demonstrated only 6% TWL for laparoscopic adjustable gastric banding (LAGB) at the same time point.  Patients' quality of life improvements, as measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, were shown to be durable with a sustained increase of 20 units from their preoperative level, and the Three-Factor Eating Questionnaire (TFEQ) showed that patients continued to have a 50% reduction in hunger.

Among participants with pre-diabetes or metabolic syndrome at baseline, approximately 50% demonstrated resolution of pre-diabetes or metabolic syndrome at 24 months, compared to baseline. Among the subset of participants with abnormal cardiovascular or metabolic conditions at baseline, statistically significant improvements were observed in mean low density lipoprotein (LDL) cholesterol (−16 mg/dL) and high density lipoprotein (HDL) cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg), and hemoglobin A1c (HbA1c) (−0.3 %).

Scott A Shikora

"Without altering the anatomy of the gastrointestinal system, vBloc's potential for serious adverse events is minimal, and the ReCharge study helps solidify this important fact. vBloc's safety profile may serve as a future benchmark for obesity treatment options," said Dr Scott A Shikora, Chief Medical Officer of EnteroMedics.

In addition, the authors reported that the safety profile of vBloc Therapy remained favourable at 24 months, compared to complications observed with conventional bariatric procedures such as sleeve gastrectomy and gastric bypass. Ninety-four percent of all adverse events were reported as mild or moderate in severity, and 83% of events had resolved by 24 months. Three serious adverse events were reported and adjudicated by the independent clinical events committee to be unrelated to vBloc therapy.

"These findings are crucial as we continue to advance towards our goals of both expanding the reach of this proven technology, as well as obtaining reimbursement for patients in need," says Dan Gladney, Chief Executive Officer of EnteroMedics.  "These results, in combination with the first-hand patient success stories we've had the privilege of learning about, leave us confident that vBloc combined with the vBloc Achieve program, a comprehensive, personalised weight loss support programme to help vBloc patients reach and maintain health goals, hold strong potential to serve as a highly effective option in patients in dire need of new approaches to treat their obesity."

EnteroMedics' Maestro Rechargeable System has received FDA and CE Mark approval.

To access the paper, please click here

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