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VBLOC therapy

EnteroMedics changes its name to ReShape Lifesciences

EnteroMedics has formally changed its name to ReShape Lifesciences, the new name reflects the company’s expansion and growth into a full-scale provider of medical devices to address the continuum of care for obesity and its associated health conditions. The company’s portfolio, designed to help patients lose weight and live a healthier life, includes two FDA-approved devices, the vBloc System and ReShape Integrated Dual Balloon System, as well as the Gastric Vest System, an investigational device.

EnteroMedics starts Post-Approval ReNEW vBloc study

EnteroMedics has started its US FDA post-approval study of the vBloc System, a medical device used to treat obesity. The ReNEW Study: Maestro New Enrollment Post-Approval Study (ReNEW) will evaluate the long-term safety and effectiveness of the vBloc System for weight loss in obese patients in a real-world clinical setting.  

Study concludes vagal nerve blocking Therapy is cost-effective

EnteroMedics has announced that a cost-effectiveness study analysing vBloc Therapy for the treatment of obesity was published in the American Journal of Managed Care. The study, ‘Cost-Effectiveness Analysis of Vagal Nerve Blocking for Morbid Obesity’, concludes that vBloc Therapy for Class II and III obese patients with diabetes and Class III obese patients without diabetes, is likely to be a cost-effective alternative to conventional weight loss therapy and that vagal nerve blocking represents good value for the money from the perspective of a US payer.

EnteroMedics launches affordable vBloc Therapy programme

EnteroMedics has launch of the vBloc Now programme, which provides qualified patients access to vBloc Therapy at a reduced cost in partnership with select bariatric and weight loss centres across the United States. vBloc Therapy is designed to help patients feel full, eat less food, and lose weight, thereby improving their overall health.

EnteroMedics’ vBloc Therapy used for failed gastric sleeve

EnteroMedics has announced a first-of-its-kind procedure in which the company's vBloc Neurometabolic Therapy was used as an adjunctive treatment in two patients with obesity who failed to achieve sufficient weight loss and diabetes control with their previous gastric sleeve surgeries. Both vBloc procedures were performed at the VA North Texas Health Care System by Dr Sachin Kukreja, Director of Bariatric Surgery.

ReCharge Study: vBloc Therapy shows 34% EWL

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.

EnteroMedics update on vBloc trained centers and physicians

EnteroMedics has announced that 15 centres have been certified and 19 physicians were trained in implanting and administering vBloc Therapy as of the end of the first quarter of 2015, supporting the company's goal of training 20-25 vBloc Therapy centres and physicians by the end of 2015. EnteroMedics' bariatric centre selection, training and certification process follows a defined protocol that includes rigorous centre qualification criteria and didactic and surgical training.

EnteroMedics gains FDA approval for VBLOC Therapy

EnteroMedics has announced that the FDA has approved VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of adult patients with obesity. The Maestro System is the first new medical device to be approved by the FDA for obesity in over ten years. EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the US this year.

VBLOC Therapy gains T2DM expansion in Europe

EnteroMedics has announced that its CE Mark for the Maestro Rechargeable (RC) system for obesity has been expanded to include the management of T2DM through improved glycaemic control. The Maestro System initially received CE Mark in 2009 for the treatment of obesity (BMI30-55) and is listed on the Australian Register of Therapeutic Goods. CE Mark is a conformance mark granted by the European Commission that provides marketing approval in the countries of the European Economic Area, and that is recognized by many nations, including Australia.

DM2 ENABLE data shows reduction in HbA1c levels

Three year diabetes, hypertension and weight loss data from the DM2 ENABLE Study of VBLOC vagal blocking therapy delivered via the Maestro Rechargeable (RC) System, presented XIX IFSO World Congress in Montreal, Canada, has revealed that at 36 months, HbA1c levels dropped from 7.6% at baseline to 7.0% (p=0.04).  Furthermore, 83% of the patients who were being treated with one or more diabetic medications at the start of the trial reported no change, a decrease or discontinuation of their medication suggesting that the progression of their diabetes had been modified. 

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