EnteroMedics® Inc. has received FDA approval for the VBLOC neurostimulation weight loss device in January 2015.
VBLOC is a surgically implanted neuromodulation device delivering intermittent vagal nerve block. It consists of a rechargeable pulse generator implanted sub-cutaneously and two leads with a distal electrode. The electrodes are placed on the trunks of the vagus nerve close to the gastroesophageal junction.
The trial providing the basis for FDA approval consisted of 157 patients randomized to VBLOC or sham. At one year, %EBWL was 24.4 ± 23.6% in the VBLOC group compared to 15.9 ±17.7% in the control group.
FDA approved criteria for use of the VBLOC are:
- Adults >18 years old
- Have attended a supervised weight loss program within the last 5 years
- BMI between 35 and 40 with a health-related condition
- or BMI between 40 and 45
SAGES Technology & Value Assessment Committee
Tech Alert, March 2015
By Dan Azagury, MD