FDA Approves AspireAssist Device
to Treat Obesity

Published in June/July Issue             

The U.S. Food and Drug Administration (FDA) approved a new device that uses a surgically-implanted tube to drain a portion of the contents of a person’s stomach after he or she eats.

In granting its approval for the device known as AspireAssist, the FDA said the device should not be used on patients with eating disorders or be used for short durations on those who are moderately overweight. The treatment is intended to assist in weight loss in patients 22 and older who have obesity, a body mass index (BMI) 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, MD, 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.”

The AspireAssist System is manufactured by Aspire Bariatrics located in King of
Prussia, Pennsylvania.

To place the device, surgeons insert a tube in the stomach with an endoscope through a small incision in the abdomen. According to an FDA news release, a disk-shaped port valve that lies flush outside the body against the abdomen is connected to the tube and remains in place. Approximately 20 to 30 minutes after a meal, the patient his or herself attaches the device’s external connector and tubing to the valve, opens it and drains the contents. Once opened, it takes approximately 5 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 treated with AspireAssist and lifestyle therapy and 60 control patients who received only 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.

Clinical trial results also suggested that both patient groups had small improvements in conditions associated with obesity including diabetes and hypertension. These improvements may also be due to the lifestyle therapy, which included nutrition and
exercise counseling.

In a story in the Philadelphia Inquirer, David Tichansky, director of bariatric surgery at Thomas Jefferson University Hospital, said he had a concern that the mechanics of the device mimic the eating disorder bulimia, but credited the manufacturer for trying to find another way to help patients with obesity.

Stacy Brethauer, MD

Stacy Brethauer, MD, a bariatric surgeon at the Cleveland Clinic and president-elect of the American Society for Metabolic and Bariatric Surgery (ASMBS), told the Inquirer that the long-term value of the device has yet to be determined.

Patients require frequent monitoring by a healthcare provider to shorten the tube as they lose weight and reduce girth. Frequent medical visits are also necessary to monitor weight loss and the use of the device, as well as to provide lifestyle counseling. The device also has a safety feature that keeps track of the number of times the drain tube is connected to the port, and automatically stops working after 115 cycles (approximately five to six weeks of therapy). Patients must return for a medical visit to get a replacement part for the device to continue therapy.

Side effects related to treatment include occasional indigestion, nausea, vomiting, constipation and diarrhea. The device is contraindicated in those with certain conditions, including uncontrolled hypertension, diagnosed bulimia, diagnosed binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease or stomach ulcers. It is also contraindicated in patients with a history of serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain or those at a high risk of medical complications from an
endoscopic procedure.