The Food and Drug Administration announced Tuesday that it has approved a treatment for those battling obesity that uses a surgically-placed tube to drain stomach contents after meals.
The device is called AspireAssist, and it is approved for use for people age 22 and over who are moderately overweight. According to the FDA, those with a body mass index of 35 to 55 and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy are eligible for the treatment.
In a trial that included 171 people, 111 were implanted with the AspireAssist, along with being given appropriate lifestyle therapy. The other 60 participants only were given lifestyle therapy. Those implanted with AspireAssist lost 12.1 percent of their total body weight after one year, compared to just 3.6 percent for those just receiving the lifestyle therapy.
“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “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.”
Surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen to place the device, the FDA said. A disk-shaped port valve that lies outside the body, flush against the skin of the abdomen, is connected to the tube and remains in place, the administration added.
Roughly 20 to 30 minutes after consuming a meal, the person opens the valve which takes the food content and drains it out of the person's body. The process takes five to 10 minutes, and can remove 30 percent of the calories consumed.
The FDA said the side effects of the device are indigestion, nausea, vomiting, constipation and diarrhea.
