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vBloc study

EnteroMedics starts Post-Approval ReNEW vBloc study

Study designed to further demonstrate long-term safety and efficacy of vBloc for weight loss in obese patients

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.  

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. The vBloc System is designed to give the patient a sensation of fullness, empowering them to eat less, control their appetite, and lose weight. Studies have shown that vBloc Therapy produces meaningful weight loss while also reducing comorbidity factors related to obesity.

ReNEW is a five-year, multi-centre trial that will provide 200 patients with vBloc Neurometabolic Therapy at approximately 10-15 centres across the US.  All patients will participate in a weight management program consisting of recommendations regarding diet, exercise and behaviour modification throughout the study. The primary safety objective of ReNEW is to demonstrate that the rate of serious adverse events (SAEs) related to implanting vBloc is statistically lower than 25% at five years.  Primary efficacy endpoints for ReNEW will examine various measures of excess weight loss (EWL) and total body weight loss (TBL). There are currently three centers with IRB approval for the ReNEW Study.

Separately, EnteroMedics is working in collaboration with Kaiser Permanente on a Type 2 Diabetes Study with vBloc and is concurrently running its vBloc Now program, which offers commercial patients access to vBloc Therapy at a reduced-cost with the goal of collecting additional real-world outcomes data to support reimbursement.

The first patient in the company's ReNEW Study was enrolled at NYU Winthrop Hospital in Mineola, NY, by the site's principal investigator (PI), Dr Collin Brathwaite, Chairman of Surgery and Chief of the Division of Minimally Invasive Surgery, Director of the Bariatric Surgery Program.

"We are so pleased to both participate in the ReNEW Study, as well as to provide vBloc as a covered benefit for all of our employees at NYU Winthrop Hospital," said Dr. Brathwaite. "vBloc is an important innovation in the weight loss care continuum that provides patients with access to a minimally invasive, non-anatomy altering solution to obesity that has been shown in clinical trials to improve patient outcomes."

"With recent focus on real-world evidence by the FDA, post-approval studies such as ReNEW allow physicians to follow the safety and efficacy of new treatments in a more complex and diverse patient population than is typically studied in pre-approval clinical trials," said Dan Gladney, Chairman, President and Chief Executive Officer of EnteroMedics. "Our ability to work with our physician partners to begin this post-approval study is further evidence of EnteroMedics' commitment to help the obesity community gain additional insights about the clinical and economic benefits of vBloc."

The Maestro Rechargeable System was approved by the FDA in January 2015.

For more information on EnteroMedics' ReNEW Study, please click here

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