FDA approves manual stomach pump for obesity treatment
William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said that AspireAssist device would help keep a ideal control on calorie absorption.
Today, the U.S. Food and Drug Administration approved a new device that would help obese people absorb fewer calories – by draining a portion of their undigested stomach contents directly into the toilet. The weight loss device can effectively drain 30 percent of the consumed calories and flush it right down the toilet.
After a year, the people using AspireAssist lost an average of 12.1 percent of their total body weight compared to 3.5 percent for the control patients. While providing the device, the FDA said that this mechanism is not for people with eating discords and nor is it for people who are moderately overweight.
Lastly, health experts recommend that patients who use AspireAssist take regular counseling to help them adjust to the lifestyle programs. A surgeon will also have to implant the device in a short endoscopic procedure, and that cost may vary by center.
The tube connects to a port valve outside of the abdomen.
We all know that the way to lose, or at least control, weight is to eat less.
According to the study abstract, mean percent excess weight loss in the treatment group was 31.5% ± 26.7% on a modified intent to treat basis (vs. 9.8% ± 15.5% in controls), and 37.2% ± 27.5% on per-protocol basis (vs. 13% ± 17.6% in controls).
It’s a manual pump that drains food out of your stomach.
The AspireAssist device, which is now in the European market, doesn’t have a fixed price yet. The FDA approval is for people 22 and older. It doesn’t involve major surgery – it works by removing some of what’s in your stomach through a tube after you eat, getting rid of about a third of your calories.
The stomach contents are removed before the food is absorbed, thus helping to prevent weight gain. Those improvements, the release noted, may have been due to the lifestyle therapy, which included nutrition and exercise counseling.
Side effects related to use of the AspireAssist include occasional indigestion, nausea, vomiting, constipation and diarrhea.
The product was developed by Aspire Bariatrics of King of Prussia, Pa., and is now available in Europe, according to the company. Clinical trials showed patient lost an average of 46 pounds during the first year and another few pounds to make 50 pounds of weight loss by the second year.
“People think, “my God, you’re giving a device to people who probably already overeat and then you’re giving them a ‘get out of jail free” card by saying, ‘you can eat more, and just drain it”, she said.