FDA Announces Approval for Obesity Treatment Device AspireAssist
In a clinical trial, patients using the AspireAssist lost an average of 12.1 percent of body weight in one year
The U.S. Food and Drug Administration (FDA) has issued an approval for a device designed to assist consumers struggling with obesity.
The AspireAssist is a treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal. It is intended to assist in weight loss in patients age 22 and older who are obese, 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.
"The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy," said William Maisel in a written statement. Maisel is the 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."
Use of the AspireAssist device requires surgeons to insert a tube into the stomach with an endoscope via a small incision in the abdomen. A valve that lies against the skin of the abdomen is connected to the tube. Approximately 20 to 30 minutes after meal consumption, the patient attaches the device's external connector and tubing to the valve and drains the contents. The device removes approximately 30 percent of the calories consumed.
The FDA reviewed results from a clinical trial of more than 100 patients treated with AspireAssist and appropriate lifestyle therapy, and 60 control patients who received only the lifestyle therapy. After one year, patients using AspireAssist lost an average of 12.1 percent of their total body weight compared to 3.6 percent for the control patients.
The FDA stresses that AspireAssist should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight.
Side effects related to use of the AspireAssist include occasional indigestion, nausea, vomiting, constipation, and diarrhea.
The AspireAssist System is manufactured by Aspire Bariatrics.