St. Paul, MN-based EnteroMedics Inc. recently announced that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system. The system is indicated for treatment of obese adults having a Body Mass Index (BMI) of at least 40 to 45 (units of Kilogram per Meter squared), or a BMI of at least 35 to 39.9 with a related health condition such as high blood pressure or high cholesterol levels, and who have already tried to lose weight in a supervised weight management program within the past five years. A news release by the FDA further noted that the Maestro System is the first obesity treatment device to be approved by the FDA since 2007.
According to the Wall Street Journal, the Maestro system disrupts signals between the stomach and brain by blocking electrical signals in the abdominal vagus nerve through the use of high-frequency electrical pulses. The FDA reported that the Maestro System was evaluated in a 233-patient clinical study where the experimental group lost about 8.5% more of its excess weight than the control group in a 12 month period. The FDA further reported that about half (52.5%) of patients in the experimental group lost at least 20% of their excess weight, and 38.3% of the experimental group lost at least 25%. According to NBCnews, as part of the approval process, EnteroMedics must conduct a five year post approval study following at least 100 patients to collect additional safety and effectiveness data.
According to its website:
EnteroMedics® is committed to the delivery of safe, effective and sustainable therapies that address the growing global health crises associated with the increased prevalence of obesity and metabolic diseases, including diabetes and hypertension. EnteroMedics is rapidly advancing its novel technology, VBLOC® vagal blocking therapy delivered via the Maestro® Rechargeable System, to broadly benefit patients, health care providers and stakeholders around the world.