“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. 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. Approximately 20 to 30 minutes after meal consumption, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents. Once opened, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet. The device removes approximately 30 percent of the calories consumed.
The FDA reviewed results from a clinical trial of 111 patients and 60 control patients who received only the lifestyle therapy. After one year, patients using the device lost an average of 12.1 percent of their total body weight compared to 3.6 percent for the control patients.
Patients require frequent monitoring by a health care provider to shorten the tube as they lose weight and abdominal girth, so that the disk remains flush against their skin. Frequent medical visits are also necessary to monitor device use and weight loss and to provide counseling on lifestyle therapies.
Side effects related to use of the AspireAssist include occasional indigestion, nausea, vomiting, constipation and diarrhea.