The U.S. Food and Drug Administration have given approval for a novel surgically implanted device to treat obesity sufferers.
The Aspire Assist device makes use of a tube to drain some portion of the stomach contents following every meal. It’s intended to be used by individuals who have been incapable to reduce weight and maintain weight loss using non-surgical therapies. The FDA acceptance is for individuals aged 22 and above .
The device is suggested for obese individuals with a body mass index (BMI) in between 35 and 55, the FDA stated. BMI is a rough estimation of body fat dependent on height and weight measurements. A BMI of 30 or above is regarded obese, with respect to the U.S. Centers for Disease Control and Prevention.
According to US FDA
The device should not be used in individuals with eating disorders. It also isn’t designed for short-term use in moderately overweight individuals.
With the Aspire Assist, a tube is placed in the stomach and linked to a port valve placed flush against the skin of the abdomen. Around 20 to 30 minutes following each meal, the individual connects an external connector and tubing to the port valve, opens up the valve, and drains some stomach material into the toilet.
The procedure takes 5 to 10 minutes and eliminates about 30 % of the calories taken in the meal.
The acceptance was based upon the outcomes of a clinical study of 111 sufferers who used the Aspire Assist and a control group of 60 sufferers who made lifestyle modifications only. After a year, sufferers in the Aspire Assist group dropped an average of 12 % of their total body weight. The control group dropped an average of less than 4 % of their weight, investigators said.
Dr. William Maisel, the deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health said,
“The Aspire Assist method helps offer efficient control of calorie absorption, which is an essential principle of weight control therapy”.
“Sufferers should be consistently supervised by their health care provider and should adhere to a lifestyle program to assist them develop much healthier eating habits and decrease their calorie intake.”
Side effects related with use of the Aspire Assist consist of constipation, diarrhea, indigestion, nausea and vomiting. There are also a variety of risks related with the placement of the device, such as pain, bleeding, infection, inflammation, accidental puncture of the stomach or intestinal wall, and death, the FDA said.
The device is made by Pennsylvania-based Aspire Bariatrics.