First-of-Its-Kind Device to Treat Obesity Gets FDA Approval
The Food and Drug Administration (FDA) has approved EnteroMedics' VBLOC vagal blocking therapy, delivered via the Maestro System, which is the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
The Maestro Rechargeable System is indicated for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40–45kg/m2, or a BMI of at least 35–39.9kg/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.
The System is made up of a rechargeable electrical pulse generator, wire leads, and electrodes that are surgically implanted into the abdomen. With the VBLOC Therapy, electrical pulses are sent to the trunks in the abdominal vagus nerve, which plays a role in stomach emptying and sending signals to the brain that the stomach feels empty or full. The specific mechanisms for weight loss due to the VBLOC Therapy are unknown, but electric stimulation is known to block nerve activity between the stomach and brain.
Its safety and efficacy were evaluated in a clinical trial that included patients with a BMI of ≥35 (n=233). Study results showed that after 12 months, the experimental group who received the active Maestro device lost 8.5% more of its excess weight than the control group who received an inactivated Maestro device. About 52.5% of the those in the experimental group lost at least 20% of their excess weight, and 38.3% of those lost at least 25% of their excess weight.
VBLOC Therapy is contraindicated for use in patients with cirrhosis of the liver, portal hypertension, esophageal varices or an uncorrectable, clinically significant hiatal hernia; patients for whom magnetic resonance imaging (MRI) 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).
For more information call (651) 634-3003 or visit EnteroMedics.com.