This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: The Maestro Rechargeable System
Applicant: EnteroMedics, Inc.
Address: 2800 Patton Road, Saint Paul, MN 55113
Approval Date: January 14, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130019a.pdf
What is it? The Maestro Rechargeable System is a weight-loss treatment for patients who are morbidly obese or who are obese with one or more obesity-related conditions. The Maestro Rechargeable System contains some components that are implanted inside the body and some that are outside the body. The internal components include a rechargeable pulse generator (also called a neuroregulator disc) which delivers electrical signals to nerve electrodes. The electrodes are placed on the trunks of the vagus nerve in the abdomen and two electrical leads connect the electrodes to the pulse generator. The external components include a transmit coil, mobile charger, and clinician programmer.
How does it work? The Maestro Rechargeable System delivers small electrical pulses to block transmission of nervous signals in the vagus nerve (vagal blocking therapy, or VBLOC therapy). VBLOC therapy is intended to promote weight loss by suppressing neural communication between the brain and the stomach. The vagus nerve is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. The precise mechanism of weight loss related to the use of the device is not clear.
When is it used? The Maestro Rechargeable System is intended for people who are at least 18 years old and are obese, with a Body Mass Index (BMI) of 40 to 45 or with a BMI of 35 to 39.9 and one or more obesity-related health condition such as high blood pressure or high cholesterol. The Maestro Rechargeable System is for use in obese patients who have first tried to lose weight by diet and exercise in a supervised program within the last 5 years.
What will it accomplish? In a study conducted by the manufacturer, the group of people who used this device lost 8.07 pounds more than those in a control group (8.5% more of their excess weight). In this study 233 patients participated in the ReCharge study at 10 investigational sites (8 in the U.S., 2 in Australia). This total included 157 who received the VBLOC treatment and 76 who had the device implanted but not turned on. After 12 months, the average excess weight loss in the VBLOC group was 24.4 ± 23.6% (an average of 24.14 pounds). The average excess weight loss in the control group was 15.9 ±17.7% (an average of 16.07 pounds).
When should it not be used? Patients are not candidates for the Maestro Rechargeable System if they have any of these medical conditions:
- Cirrhosis of the liver
- Increased pressure in hepatic veins (portal hypertension)
- Dilated veins in the esophagus (esophageal varices)
- Hiatal hernias that are clinically significant and cannot be corrected by surgery
Patients are not candidates for the Maestro Rechargeable System if they are at high risk for surgical complications, have another permanently implanted, electrically-powered medical device (such as a heart pacemaker, implanted defibrillator, or neurostimulator), or if their doctors anticipate the need for magnetic resonance imaging (MRI) or procedures that require diathermy.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.