The US FDA has green lighted a new weight loss device which will enable obese people to drain 30 percent of their stomach contents after eating through a surgically placed tube in the stomach.
The device named AspireAssist, developed by Aspire Bariatric, consists of a tube inserted into the patient’s stomach through a small incision in the abdomen. The tube connects to a port valve which lies just outside the skin of the abdomen.
It remains in place throughout the duration of treatment, according to a Wall Street Journal report. As such, it is not recommended for a short treatment period among moderately obese patients.
Half-an-hour after eating, the patient will attach an external tubing device to the port that opens the valve then drains about 30 percent of the stomach contents for 5 to 10 minutes. It empties the stomach's contents before the body absorbs the calories, and will eventually result in preventing weight gain.
The device is meant to facilitate weight loss among obese patients – with a BMI range between 35 to 55 and aged 22 or older – who have been unsuccessful at losing weight through non-surgical treatments.
Daily Mail reports the device is contraindicated for patients with eating disorders. FDA further cites uncontrolled hypertension, night eating disorder, pregnancy, inflammatory bowel disease, stomach ulcers, and severe pulmonary and cardiovascular diseases as additional contraindications.
William Maisel, M.D., M.P.H., of the FDA, said the device is helpful in providing effective control of calorie absorption – which is an important factor in weight management, according to the agency's press release.
The AspireAssist device was put on a clinical trial involving 111 participants, and compared to a group of 60 patients who received weight loss treatment that centered on lifestyle modifications.
After a year, the device group lost an average of 12.1 percent of their total body weight compared to 3.6 percent from the lifestyle group. However, both groups showed improvements in obesity-related health conditions such as hypertension and diabetes.
Following the application of the device, the FDA recommends frequent monitoring in case the tube needs shortening as the patient loses weight. The agency also recommends medical visits for lifestyle therapy counseling.
To ensure the device is properly used, the developers added a safety feature that tracks the number of times the drain tube is connected to the port. It stops after 115 cycles (5 to 6 weeks of therapy) after which the patient will need to return to a medical institution to get a replacement part.
The therapy does not come without side effects. The FDA notes risks associated with abdominal opening of the port valve that includes abdominal pain, bloating, inflammation of the skin around the site, leakage, bleeding, and infection. MIMS
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