Today, the US Food and Drug Administration has given green signal to a new obesity treatment device called AspireAssist that will help drain certain part of contents in stomach after every meal.
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A Pennsylvania-based company, Aspire Bariatrics, developed the device which is made up of a pump that must be connected to a hose implanted in the person’s stomach. In the second year the weight loss increased to 50 pounds.
To get FDA approval, the device obviously had to pass a bunch of tests. This new device is the first to remove food that people have already eaten before it can be digested.
The FDA further stated that the device is specifically for patients who are of age 22 or older and are obese with a body mass index of around 35 to 55. Patients require regular monitoring by their healthcare provider to shorten the tube length as they lose weight and abdominal girth.
AspireAssist is not intended for patients with eating disorders or for use in short durations for patients who are moderately overweight.
The AspireAssist clinical trial provided to the FDA suggested that the 111 patients using the device lost more weight compared to a 60-person control group who were only provided with lifestyle therapy.
Around 30 minutes after eating, the AspireAssist device allows an obese patient to pour 30 per cent of the contents of their stomach out via the tube and into the toilet. According to the manufacturer, the procedure takes only 15 minutes, and the whole device can be removed in 10.
About 38 per cent of all USA adults are obese.
“Patients need to be regularly monitored by their health care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake”, said Maisel. BMI is a rough estimate of body fat based on height and weight measurements.
Surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen to place the device, the FDA said.
After one year, patients using AspireAssist lost an average of 12.1 per cent of their total body weight compared to 3.6 per cent for the control patients.
Data from the trial also indicated small improvements in conditions associated with obesity, including diabetes, hypertension and quality of life – though the improvements may be attributable to the lifestyle therapy treatments that are included alongside treatment with the device.
While the benefits of using the gadget are significant, it is important to note that the FDA has warned users of nausea, constipation, diarrhea and indigestion as side effects of using it.
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“With less than 1% of the 25 million Americans with BMIs over 35, availing themselves of bariatric surgery each year, there is clearly a need for a non-surgical weight loss procedure that is effective, safe, and reversible”, says Dr. Christopher Thompsoon of the Harvard Medical School.
