US approve world's first Obesity Treatment Device : Is it Safe ?

By Mediplex Health Editor: Dr. Sharma, MD




In a recent breakthrough, FDA has approved a new device in the obesity treatment

This device is invented by Maestro Rechargeable System and it sends electrical signals to a critical nerve in the body known as vagus nerve. The function of this nerve to tell brain whether stomach is full or not. This device target the pathway between stomach and brain.

Technically, the system consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen.

Though device is found to be safe as per experts but their opinion remain divided about the efficacy of the device. Over 5 advisor were doubtful of its efficacy.
It will be used for the morbidly obese patients whose BMI is between 35 and 45 with associated clinical condition-type 2 diabetes. Mediplex Obesity experts evaluated the clinical trial data pertaining to this trial and found that trial was conducted on 233 patients with BMI greater than 35. The experimental group (157 patients) which recieved activated device lost 8.5 % more weight than the control group. The control group (76 patients) who recieved the non-activated device could not loose as much weight the experimental group.

The key conclusions of the study after 12 months:

  • 52.5% of the patients in the experimental group lost at least 20% of their excess weight 38.3% of patients in the experimental group lost at least 25% of their excess weight.
  • Serious and other adverse events reported in the clinical study include: Given the large number of serious side effects, how is it recieved by the obese patients remains a question to answer. Further manufacturer declined to answer questions about the cost and availability of device. The benefits of using the device is directly linked with reduction of weight in the given patient namely reduction of risks associated for clinical conditions such as high blood pressure and type 2 diabetes. Importantly, all these patients were advised to undergo dietary counseling and exercise program. Therefore, utility of this device in treatment of obesity in isolation remains a question.