Study Supports Efficacy of EnteroMedics’ Weight Loss Device

EnteroMedics Inc., developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, has announced an assessment of real-world, clinical practice weight loss data in patients using the company’s vBloc Therapy in combination with vBloc Achieve, which confirms previously reported positive results from the ReCharge Pivotal Trial. These data show similar mean percent total weight loss (TWL) through six (9 percent) and nine months (10 percent) as compared to results from the rigorous ReCharge Pivotal Trial (9 percent at six months; 10 percent at nine months). The data were collected at vBloc Institutes across the United States. vBloc Institutes are facilities that have integrated vBloc Therapy and vBloc Achieve into their practices.
 
“The patients who received their vBloc Therapy implant at vBloc Institutes and participated in the company’s vBloc Achieve support program achieved total weight loss comparable with the patients in the ReCharge Pivotal Trial, which utilized a very demanding patient follow-up protocol and was used to secure FDA approval,” said Dan Gladney, EnteroMedics president, CEO and board chairman. “The corroboration of our clinical trial results in an everyday environment provides additional support for vBloc as a revolutionary treatment option for morbidly obese patients who do not wish to undergo anatomy-altering weight-loss procedures. These data are yet another important proof point in the advancement of our commercialization strategy and efforts to secure broad reimbursement coverage to make vBloc Therapy widely available to all patients. The commercial results appear to be equal to the solid results from our clinical trial and we will be submitting these data for presentation at a future medical meeting and for journal article publication as appropriate.”
 
As previously reported, the ReCharge Pivotal Trial is a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial of vBloc Neurometabolic Therapy in 239 patients with obesity. At 24 months, 76 percent 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 percent, with a mean percent total weight loss (TWL) of 8 percent. Of the 24 Sham control patients who had not yet crossed over to vBloc at 24 months, the EWL and TWL was 4 percent and 1 percent, respectively.
 
The ReCharge Trial confirmed the durable nature of weight loss achieved with vBloc Therapy and the positive impact it had on patients’ obesity-related comorbidities. 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 percent reduction in hunger. The safety profile of vBloc Therapy remained favorable at 24 months compared to complications observed with conventional bariatric procedures such as sleeve gastrectomy and gastric bypass.
 
vBloc Therapy works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally-invasive procedure that does not alter or remove any patient anatomy. This device can be adjusted to optimize patients’ therapy needs. Patients feel the sensation of fullness, empowering them to eat less, control their appetite, make healthier choices and lose weight without the major lifestyle implications of traditional weight loss surgeries.
 
vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a BMI of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as Type 2 diabetes, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last five years.
 
vBloc Achieve is a comprehensive, personalized weight loss support program to help vBloc patients reach and maintain health goals. While vBloc Therapy addresses hunger signals and cravings, vBloc Achieve provides the coaching and emotional support necessary to help patients make positive lifestyle changes, including healthy, balanced eating and regular exercise that are essential to long-term weight loss success. vBloc can be adjusted postoperatively for a patient’s lifestyle or eating patterns in order to optimize therapy when patients need it the most.
 
EnteroMedics developed neuroscience-based technology to treat obesity and metabolic diseases. vBloc Neurometabolic Therapy, delivered by a pacemaker-like device called the vBloc System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ vBloc System has received U.S. Food and Drug Administration approval and CE Mark. The company is based in St. Paul, Minn.