EnteroMedics Inc. announced that the U.S. FDA has just approved VBLOC® vagal blocking therapy for the treatment of obese adults with a Body Mass Index (BMI) of 40 and 45 kg/m2, or BMI between 35 and 39.9 kg/m2, and with a weight-related health condition, such as high cholesterol levels, high blood pressure; or those who tried to lose weight through other supervised programs in the last five years, with minimal success. This therapy is delivered through the Maestro® System.
The Maestro System is the first new medical device for obesity approved by the FDA in over ten years. The EnteroMedics company anticipates that this device will be available this year, on a limited basis and at a select Bariatric Centers of Excellence in the United States.
Scott Shikora, from EnteroMedics, explained in a press release: “VBLOC Therapy offers an entirely new approach to the treatment of obesity. 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 device can be compared to a pacemaker, in that it is also implanted through an outpatient procedure, except for the purpose of controlling hunger and fullness. It blocks the primary nerve that controls the digestive system. The VBLOC approach does not alter surgically the digestive system nor restricts it, it does not prevent the absorption of nutrients, and it is reversible.
Joe Nadglowski, Obesity Action Coalition President, said: “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.”
Mark B. Knudson, EnteroMedics’ CEO, concluded: “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 (…) 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.”