VBLOC Approved: First New Device for Obesity in a Decade

VBLOC Approved: First New Device for Obesity in a Decade

FDA today approved the first new medical device for the treatment of obesity in more than a decade, the EnteroMedics Maestro VBLOC system. An FDA advisory committee issued a split, but positive decision on this device last June, concluding it offers benefits which outweigh its risks.

The VBLOC system works by blocking impulses of the vagus nerve that transmit feelings of hunger from the gut to the brain. The device is implanted, much like a cardiac pacemaker and then charged and controlled wirelessly. In clinical studies, it was more effective than implantation of a sham device. In absolute terms, its efficacy (on average) appears to be less than the efficacy of gastric bypass surgery. But its safety appears to be greater, because implanting the device involves a less dangerous surgical procedure.

Commenting on the approal, FDA Deputy Director William Maisel said:

Obesity and its related medical conditions are major public health problems. Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.

Professor Caroline Apovian of the Boston University School of Medicine said:

From diet and exercise to bypass surgery, existing treatment options have failed to stop the advance of this obesity. The Maestro System adds a safe and effective new weapon to our armamentarium, offering patients a treatment option that does not physically restrict or alter the anatomy, and is reversible.

Obesity Action Coalition CEO Joe Nadglowski said:

OAC applauds the FDA and EnteroMedics for making available the first device for the treatment of obesity in more than a decade. There is no ‘one-size-fits-all’ approach to treating the disease of obesity. We believe strongly that expanded treatment options are essential to individuals affected by obesity, so that along with their healthcare provider, they can make an informed decision on which option, or options, may work best to improve their health.

Click here to read more from FDA, here to read more from Yahoo Finance, and here to read more from ConscienHealth. For even more detail, click here and here for the briefing documents published by FDA for last June’s expert advisory committee meeting.

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6 Responses to “VBLOC Approved: First New Device for Obesity in a Decade”

January 14, 2015 at 12:58 pm, Barbara G said:

I’ve read the comparison above to the gastric bypass.

I’m wondering how this compares to the efficacy of the laparoscopic band and/or the vertical gastric sleeve.
- January 14, 2015 at 8:25 pm, Ted said:
  
  First and foremost, no direct comparisons are available. Individual responses vary greatly.
  
  I would be surprised if the average effectiveness of the VBLOC device matched gastric sleeve. I’m not so sure about the gastric band. But again, generalizations are dangerous, because good comparative data are not available.
January 14, 2015 at 5:00 pm, Seval said:

I’ll need more detail please.
- January 14, 2015 at 8:37 pm, Ted said:
  
  For more detail, click here and here.
January 15, 2015 at 8:29 am, Susan Burke March said:

So, what do you think about making this device available to people before they become severely (Class 2) Obese? It seems to me that an effective device to help people modify their behaviors before they reach the stage that they’re so vulnerable to obesity-related illness would be proactive and prudent.
- January 15, 2015 at 12:04 pm, Ted said:
  
  More clinical experience needed to fully define the best uses.