Friday, April 25, 2014

VBLOC, a Potential Endoscopic Bariatric Therapy, to Get FDA Review

Bariatric or weight loss surgery is an effective weight loss method. Non-surgical weight loss approaches, such as using weight loss drugs, and making lifestyle changes, including diet and exercise, are often less effective than weight loss surgery. But severe complications sometime accompany the surgery. Fortunately, some experts are looking into treatment options that mimic bariatric surgery while eliminating many of the complications associated with the surgery. Some of these options are called endoscopic bariatric therapies or EBTs. One possible, future EBT that is scheduled for FDA review in its current non-EBT form is VBLOC therapy.

EBTs can be categorized three ways: They may be restrictive, malabsorptive, or neuro-hormonal. The  gastric balloon is an example of a restrictive EBT.  This device is placed in the stomach, endoscopically. Once the device is filled with a liquid or air, a person’s stomach feels full with less food. ReShape Medical, Inc, headquartered in San Clemente, California, makes a version of the gastric balloon.

The  Endobarrier is a malabsorptive EBT. The device is made by Lexington, MA based GI Dynamics. The Endobarrier is a liner for a section of the small intestine. And like the gastric balloon, the Endobarrier is placed in the intestine endoscopically. The Endobarrier is engineered to act as a barrier between the food one eats and the intestinal walls. With the Endobarrier in place, food digestion is delayed in a fashion similar to gastric bypass surgery.

Finally, an example of a potential neuro-hormonal EBT is VBLOC.  VBLOC was developed by EnteroMedics Inc., based in Minnesota. Although the VBLOC system is placed in the digestive system, laparoscopically, this type of device may one day be inserted endoscopically. The system blocks signals sent from the digestive system to the brain, via the vagus nerve. The signals can contain messages associated with hunger, satisfaction and fullness. 
EnteroMedics recently "announced that the U.S. Food and Drug Administration's Office of Device Evaluation has scheduled a meeting of the Center for Devices and Radiologic Health's (CDRH) Advisory Committee on Thursday, May 29, 2014 to review the Maestro(R) System delivering VBLOC(R) vagal blocking therapy as a treatment for morbid obesity."

If EBTs are eventually proven to be effective weight loss fighting tools, medical weight loss options will be enhanced. Patients, obesity medicine specialists, and bariatric surgeons will then benefit. So medical and surgical weight loss service providers should monitor EBT research. This will allow these providers to know when and how to counsel their patients on EBT application.


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