The United States Food and Drug Administration (FDA) approved EnteroMedic's VBLOC® vagal blocking therapy, delivered via the Maestro® System, which is the first medical device approved for obesity treatment that targets the nerve pathway between the brain and the stomach. The device acts by sending an electrical pulse to block vagal nerve signals involved in controlling feelings of hunger and fullness. The Maestro System is approved for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 35 to 45 kg/m2 with one or more obesity-related health condition and who have failed to lose weight in a supervised weight management program within the past five years.
"This is a novel device that interrupts signals from the stomach to the brain that are believed to be involved with stomach emptying and feelings of fullness," said Martin Binks, PhD, FTOS, Secretary/Treasurer of The Obesity Society (TOS) and Associate Professor of Nutritional Sciences at Texas Tech University. "In clinical trials the device resulted in a clinically meaningful weight loss of 8.5% after one year and the FDA determined this was an appropriate risk-benefit profile to approve the device for clinical use."
The FDA has requested the company collect additional safety and efficacy over five years.
For many years, TOS has advocated for enhanced understanding and treatment of obesity as a complex, chronic disease in need of new treatment options. Obesity puts individuals at risk for more than 30 health conditions, including heart disease, type 2 diabetes, high cholesterol, hypertension and numerous cancers, among many others. TOS researchers and clinicians agree: losing weight and maintaining weight loss solely by altering lifestyle changes, while effective for some people, can often be difficult or impossible to accomplish for others. However, clinicians have very few tools for obesity treatment, particularly when compared with treatment options for other chronic diseases.
"We're encouraged that FDA is willing to continue to consider adding important and innovative new options to the treatment toolbox," said Dr. Binks. "In addition to the five FDA-approved anti-obesity drugs now available, these novel treatment options can give additional choices to individuals with obesity who have found little success with diet and exercise alone. Medical devices can be part of comprehensive, individualized obesity treatment plan for some patients."
The Obesity Society is encouraged by the many recent actions FDA has undertaken to approve anti-obesity treatments and hopes to see continued positive momentum.
"For the first time in history, we see a glimpse of the future for obesity treatment -- the potential to treat the disease with a full spectrum of tools," said Dr. Binks.
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