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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.

Acquisition - EnteroMedics acquires ReShape Medical

EnteroMedics has announced that it has acquired ReShape Medical, a privately-held medical technology company that develops, manufactures and markets the ReShape Dual Weight Loss Balloon, an FDA-approved, minimally invasive intragastric balloon designed to treat obesity patients with a BMI 30-40, with one or more related comorbid conditions.  

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 gains approval for Gastric Vest study in Spain

EnteroMedics has received approval from the Ministry of Health, Social Services, and Equality (MHSSE) in Spain through the Agency of Medicines and Medical Devices, and the CEIC Ethics Committee to initiate a clinical trial for the Gastric Vest System (GVS) in Spain.

EnteroMedics expects the safety and performance CE Mark study for the Gastric Vest to include a total of between 50-100 patients at up to four sites within the European Union. This approval by the MHSSE in Spain represents the first country approval for the Gastric Vest CE Mark trial. 

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 acquires the Gastric Vest System from BarioSurg

EnteroMedics has acquired the Gastric Vest System through its acquisition of BarioSurg. The Gastric Vest is an investigational, minimally-invasive, laparoscopically implanted medical device being studied for weight loss in morbidly obese patients.

3-year vBloc data shows significant and sustained weight loss

Three-year data from the VBLOC DM2 Study of vBloc Neurometabolic Therapy in obese patients with Type 2 diabetes, has reported that the average percentage excess weight loss (%EWL) was 21% with reductions in haemoglobin A1c (HbA1c) of 0.6 percentage points from a baseline of 7.8%.

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.

ASMBS publishes position statement on vBloc Therapy

The American Society for Metabolic and Bariatric Surgery (ASMBS) has published a position statement, ‘American Society for Metabolic and Bariatric Surgery position statement on vagal blocking therapy for obesity’, in the journal Surgery for Obesity and Related Diseases (SOARD). The statement was prepared by Drs Pavlos Papasavas, Maher El Chaar and Shanu N  Kothari, on behalf of the ASMBS after review by the ASMBS Clinical Issues Committee.

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