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ASMBS vBLOC position statement

ASMBS publishes position statement on vBloc Therapy

The statement is issued by the ASMBS in response to a recent approval by the FDA of vagal blocking therapy for obesity is based on current clinical knowledge and published peer-reviewed scientific evidence available at this time

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.

vBloc vagal blocking therapy, delivered by a pacemaker-like device called the Maestro Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses, which helps control both hunger and fullness. vBloc allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort.

Following a review of the mechanism of action and clinical results of vBloc Neurometabolic Therapy, the statement noted that, "the quantity of the data available at this time (six published studies, approximately 600 implanted devices) and the length of follow-up indicate adequate safety and efficacy in the short and medium term."  The article concluded that "the society currently supports...vBloc for the treatment of obesity and encourages members to participate in post FDA approval studies," and that "the prospective collection of vBloc outcomes as part of the national bariatric accreditation program (MBSAQIP) is encouraged in order to establish further efficacy of this new technology."

"vBloc is an innovative and safe alternative to existing therapies, producing weight loss that restores health while directly addressing the underlying challenges of obesity for the individual, including hunger and satiety," said Dr Scott Shikora, EnteroMedics Executive Vice President and Chief Medical Officer. "The ASMBS' position statement reflects a strong level of support for vBloc within the bariatric community. We appreciate the continuing support of ASMBS and its members as vBloc is introduced as an important tool in their practices to support patients who wish to lose weight and become healthier."

The statement is issued by the ASMBS in response to a recent approval by the FDA of vagal blocking therapy for obesity is based on current clinical knowledge and published peer-reviewed scientific evidence available at this time. The statement is not intended as, and should not be construed as, stating or establishing a local, regional, or national standard of care.

EnteroMedics' Maestro Rechargeable System has received FDA approval, the CE Mark and is listed on the Australian Register of Therapeutic Goods.

To view the position statement, please click here (additional login details are required)

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EnteroMedics

American Society for Metabolic and Bariatric Surgery

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