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Maestro system

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.

Two-year vBloc Therapy outcomes published

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.

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 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. 

FDA recommends VBLOC vagal blocking therapy

The FDA Advisory Gastroenterology and Urology Devices Panel (GUDP) has voted eight to one in favour of EnteroMedics’ neuroblocking technology to treat obesity, the Maestro System. The Panel voted that the device is safe when used as designed and voted four to five against on the issue of a reasonable assurance of efficacy.  The final vote, on whether the relative benefits outweighed the relative risk, was six to two in favour, with one abstention.

EnteroMedics reveals FDA Maestro review meeting

EnteroMedics has announced that the FDA’s Office of Device Evaluation has scheduled a meeting of the Center for Devices and Radiologic Health's (CDRH) Advisory Committee on Thursday 29 May 2014, to review the company’s Maestro System delivering VBLOC vagal blocking therapy as a treatment for morbid obesity.

The CDRH Advisory Committee is an independent panel of clinical and scientific experts that helps evaluate medical devices for safety and efficacy and makes recommendations regarding benefit-risk to the FDA.

VBLOC demonstrates durable and safe weight loss

Eighteen-month efficacy and safety results from the five year ReCharge Pivotal Trial have revealed that patients in the VBLOC group (n=117), achieved excess weight loss (EWL) of 25%, or 10% total body weight loss (TBL), compared to 12% EWL, or 4% TBL for sham control group patients (n=42).

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