A medical device that helps people who are obese lose weight by draining some of their stomach contents after a meal has gained FDA approval.
Aspire Bariatrics, Inc.
The AspireAssist device is intended for adults 22 years or older with a body mass index of 35 to 55 who haven’t been able to lose weight or keep pounds off through nonsurgical weight loss methods. The device is not intended for people with eating disorders or for short-duration use by people who are moderately overweight (http://1.usa.gov/28Txm1s).
During an outpatient procedure with twilight sedation, a tube is implanted into the stomach and connected to a port that lies outside the body, flush against the skin over the abdomen. About 20 to 30 minutes after a major meal—before food is fully digested and absorbed—the patient attaches external tubing to the port valve, opens the valve, and drains a portion of the stomach contents directly into the toilet. The device removes about 30% of the calories consumed.
Controlling calorie absorption “is a key principle of weight management therapy,” William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health, said in a statement (http://1.usa.gov/1U8pZyL). “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.”
In a study conducted by the device’s manufacturer, Aspire Bariatrics of King of Prussia, Pennsylvania, 171 patients participated at 10 sites in the United States. Among them, 111 received the device, 60 did not, and all were counseled on diet and exercise. After 1 year, patients with the device lost an average of 12% of their total body weight compared with a 3.5% weight loss for those who didn’t receive the device.
Common adverse events included bleeding, irritation, and infection at the tubing implant site as well as pain, nausea and vomiting, and changes in bowel habits.