EnteroMedics Inc. has announced the U.S. FDA approval of its VBLOC® vagal blocking therapy, delivered via the Maestro® System.
The Maestro System is the first new medical device to be approved by the FDA for obesity in over ten years. It 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. Scott Shikora, MD, FACS, EnteroMedics’ Chief Consulting Medical Officer tells us; “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.”
Enteromedics points to key advantages of its approach, stating that 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.
FDA approval was based on the ReCharge Study, a randomized, double-blind, sham-controlled trial to evaluate the safety and effectiveness of the 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.
EnteroMedics says it anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
The FDA approval comes with an indication statement that covers the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 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 program within the past five years.
“Obesity is a global epidemic with far-reaching cost and consequences to both public and personal health,” said Caroline M. Apovian, MD, FACP, FACN, 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.”
Mark B. Knudson, Ph.D., EnteroMedics’ President and Chief Executive Officer stated; “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.”
Source: PR Newswire