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Product approval

EnteroMedics gains FDA approval for VBLOC Therapy

First new medical device approved for obesity in over a decade
Approval of the Maestro Rechargeable System was based on data from the ReCharge Study

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 offers an entirely new approach to the treatment of obesity," said Dr Scott Shikora, EnteroMedics' Chief Consulting Medical Officer. "By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss."

The Maestro System is a pacemaker-like device that is implanted, usually in an outpatient procedure, to control both hunger and fullness by intermittently blocking the primary nerve which regulates the digestive system, the vagus nerve. VBLOC Therapy does not surgically alter or restrict the digestive system, does not create barriers to prevent absorption of nutrients and is completely reversible, allowing patients to lose weight without lifestyle compromises.

The Maestro System works by intermittently blocking the primary nerve which regulates the digestive system, the vagus nerve.

To qualify for VBLOC vagal blocking therapy patients must have a BMI 40-45 or a BMI 35-39.9 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management programme within the past five years. 

"Obesity is a global epidemic with far-reaching cost and consequences to both public and personal health," said Dr Caroline M Apovian, Professor of Medicine at Boston University School of Medicine, and Director, Nutrition and Weight Management at Boston Medical Center. "From diet and exercise to bypass surgery, existing treatment options have failed to stop the advance of this disease.  The Maestro System adds a safe and effective new weapon to our armamentarium, offering the patient a treatment option that does not physically restrict or alter the anatomy, and is reversible."

ReCharge Study

Approval of the Maestro Rechargeable System was based on the ReCharge Study, a randomised, double-blind, sham-controlled trial to evaluate the safety and effectiveness of the Maestro Rechargeable System in treating obesity. In an intention to treat (ITT) analysis of the study results, VBLOC-treated patients achieved 24.4% excess weight loss (EWL) at 12 months. At 18 months, VBLOC-treated patients maintained a 23.5% EWL. In a responder analysis of the ITT population at 12 months, over 50% of VBLOC-treated patients achieved 20% or greater EWL.

The SAE (severe adverse event) rate, defined as the proportion of subjects in the VBLOC treated group who experienced an implant/revision procedure, device or therapy-related SAE through 12 months post-implant, was 3.7% (n=6; 95% CI: 1.4% to 7.9%) in the ITT population.  The most common (>10%) non-serious adverse events related to device, implant/revision procedure or therapy were pain at the neuroregulator site, and transient sensations of therapy such as heartburn/dyspepsia.

Although the study revealed that that patients implanted with the device lost 8.5 percent more weight than the control group, which did not meet the main goal of the clinical trial which was to show weight loss of 10 percent or more, an FDA advisory panel considered additional data and concluded that the benefits of the device outweighed the risks for certain patients.

By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness.

"The Obesity Action Coalition applauds the FDA and EnteroMedics for making available the first device for the treatment of obesity in more than a decade. There is no 'one-size-fits-all' approach to treating the disease of obesity. We believe strongly that expanded treatment options are essential to individuals affected by obesity, so that along with their healthcare provider, they can make an informed decision on which option, or options, may work best to improve their health," said Joe Nadglowski, Obesity Action Coalition President and CEO.

"FDA approval of VBLOC Therapy is a transformational event for not only EnteroMedics and the many supporters who have helped us achieve this milestone but, more importantly, for the people with the disease of obesity that have been waiting for a new option," said Dr Mark B Knudson, EnteroMedics' President and Chief Executive Officer. "The Maestro System fills a significant gap in the currently available treatment options, offering clinically meaningful weight loss without the fear or many of the side effects associated with existing bariatric options.  We thank the many patients, and their families, who have participated in the clinical trials of VBLOC Therapy. We are also grateful to the physicians and healthcare providers who have worked with us on these clinical trials, our dedicated employees, as well as to the FDA for their efforts in making this technology available."

VBLOC Therapy is contraindicated for use in patients with cirrhosis of the liver, portal hypertension, oesophageal varices or an uncorrectable, clinically significant hiatal hernia; patients for whom magnetic resonance imaging or diathermy use is planned; patients at high risk for surgical complications; and patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis (eg pacemakers, implanted defibrillators, neurostimulators).

The Maestro System has previously received CE Mark and is listed on the Australian Register of Therapeutic Goods.

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