New Weight Loss Device Approved by FDA Could Be an Alternative to Typical Bariatric Surgery
Are you at the point where you are now considering bariatric surgery for weight loss? You might want to stop and consider a new weight loss device recently approved by the FDA that uses pace-maker like implantable electronics to control an important hunger regulating nerve between the stomach and the brain.
The FDA recently granted approval the use of VBLOC® Therapy as an alternative to stomach altering surgery to help overweight and obese patients lose weight.
VBLOC® (vagal blocking therapy) is the brainchild of EnteroMedics Inc. for the treatment of adult obesity that uses a pacemaker–like device implanted around the abdominal vagus nerve that runs between the stomach and the brain. The abdominal vagus nerve is involved in regulating stomach emptying, and signaling the brain as to whether the stomach feels empty or full. Activating the device with pulses of electricity, the nerve is intermittently blocked resulting in a way to actually allow the patient and his or her doctor control feelings of hunger and fullness.
The plus of using VBLOC® Therapy over bariatric surgery is that it:
• Does not surgically alter or restrict the digestive system.
• Does not create barriers to prevent absorption of nutrients.
• Is completely reversible.
• Allows patients to lose weight without lifestyle compromises.
“VBLOC Therapy offers an entirely new approach to the treatment of obesity,” said Scott Shikora, MD, FACS, EnteroMedics’ Chief Consulting Medical Officer. “By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss.”
Clinical Trial Behind VBLOC® Therapy
The effectiveness and safety of VBLOC® Therapy was determined in a clinical trial consisting of 233 patients with a BMI of 35 or greater. Of the 233 patients, 157 were provided with an activated device while the remaining 76 patients were implanted with a non-activated device to serve as a comparison control. The patients were then followed for 12 months.
The results of the clinical trial were that the experimental group lost approximately 8.5 percent more excess weight than did the non-activated implant control group.
Although the initial test goal of losing 10% or more than the control group was not met, the FDA ruled that that the benefits of the device outweighed the risks for use in patients who met the criteria of having a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.
According to the FDA, as part of the approval, EnteroMedics Inc. must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions.
The device is expected to be available this year on a limited basis, at select Bariatric Centers of Excellence in the U.S.
For information about bariatric surgery, here are two links with facts to consider:
FDA Press Release: “FDA approves first-of-kind device to treat obesity”
EnteroMedics News Release: “EnteroMedics Announces FDA Approval of VBLOC® Vagal Blocking Therapy for the Treatment of Obesity”