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FDA Approves VBLOC Treatment For Obesity



enteromedicslogowithtechlarge3x2We don’t have great treatments for obesity, so every new evidence-based tool in the obesity treatment tool box is something to look at closely.

The latest addition, just approved by the US FDA for the treatment of obesity  in adults with a BMI of 40 to 45 kg/m2 or a BMI of 35 to 39.9 kg/m2 with a related health condition, is something I’ve posted about before – VBLOC or the vagal “pacemaker” as it is sometimes referred to.

Indeed, Enteromedics‘ rechargeable Maestro system is very much like an implantable cardiac pacemaker, in that it delivers an electronic signal – in this case to block the action of the vagus nerve. The exact mode of action is not entirely clear but the weight-loss mediating effect (in the 10-15% average range) is largely a result of reduced appetite and increased satiety.

Here is how Enteromedics describes its system:

The Maestro® System consists of a subcutaneously implanted rechargeable neuroregulator and two electrodes that are laparoscopically implanted by a bariatric surgeon. It delivers VBLOC® vagal blocking therapy via these electrodes that are placed in contact with the trunks of the vagus nerves just above the junction between the esophagus and the stomach. The device intermittently blocks vagal nerve signals throughout the patient’s waking hours. The Maestro System is recharged using an external mobile charger and transmit coil worn by the patient. The device can be non-invasively programmed, and it can be adjusted, deactivated, reactivated or completely removed if desired.”

Obviously this is far from the be-all and end-all of obesity treatments – especially as it does not seem to work for everyone. Thus, the recently published results from the pivotal study (discussed here),  was certainly far less impressive than the company may have hoped for.

Just where VBLOC treatment will ultimately find its place in bariatric care remains to be seen – this is certainly a space to watch.

@Dr. Sharma
Edmonton, AB

 

2 Comments

  1. Is this procedure available in Saskatchewan? Do some health plans cover it or is it covered under provincial plans? What are the “requirements” to be considered for this procedure? Thank you.

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