Montco Company's 'Abdominal Vomiting' Weight Loss Device Approved By FDA

The FDA has approved a new device from a Montgomery County company which pumps food out of the stomach after meals.

The device, called AspireAssist, is a surgically placed tube which drains a portion of the stomach contents after every meal, according to a press release from the U.S. Food and Drug Administration on Tuesday. 

AspireAssist is made by Aspire Bariatrics,which is located on 3200 Horizon Drive in King of Prussia.

The device has been the subject of controversy and humor, and was featured by Stephen Colbert on the Late Show in October.

The device 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, the FDA said. 

It is intended to assist in weight loss in patients aged 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,” William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a press release. “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.”

The device is installed by surgeons who place a tube in the stomach with an endoscope after making a small cut in the belly, 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. 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, according to the FDA. 

The FDA reviewed results from a clinical trial of 111 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 release states. 

Side effects can include intermittent indigestion, nausea, vomiting, constipation and diarrhea.

Image via AspireAssist.