FDA Approves Device for Weight Loss

AspireAssist obesity device approved as weight management therapy

/ Author:  / Reviewed by: Anyssa Garza, PharmD

(RxWiki News) The US Food and Drug Administration has approved a new device as a weight management therapy.

That new therapy is the AspireAssist device.

AspireAssist consists of a tube that is placed surgically and drains a portion of the stomach after you eat a meal.

This device is for individuals who are obese, older than 22, and who have not been able to achieve and maintain weight loss despite nonsurgical weight loss treatments.

AspireAssist is not to be used for a short period in people who are moderately overweight.

When placing the AspireAssist device, the surgeon will make a small incision in the stomach and insert the tube into the stomach. The surgeon will then connect a disk-shaped port valve to the tube.

To use this device, the individual will connect a connector and tubing to the port. Twenty to 30 minutes after a meal, the individual will open the valve to drain the food contents into the toilet. Once the valve is opened, it will take five to 10 minutes for the food to drain.

AspireAssist gained approval after it appeared effective in one clinical trial.

With this treatment option, patients are to be monitored closely and frequently by their health care providers. During doctor visits, your device will be monitored and adjusted to your progress.

This device also contains a safety measure in which it keeps track of the number of times it is used to drain food. AspireAssist will automatically stop after 115 cycles, which equals to about five or six weeks. At this point, the patient is to obtain a replacement device in order to continue therapy.

Patients are encouraged to establish and follow a healthier lifestyle.

Common side effects of AspireAssist included gastrointestinal issues like constipation, diarrhea, indigestion, vomiting and nausea.

AspireAssist is not to be used in those with eating disorders, uncontrolled high blood pressure, a history of certain stomach surgical procedures, an inflammatory bowel disease, stomach ulcers, a history of serious pulmonary or heart disease or blood clotting disorders. In addition, this device is not to be used during pregnancy or breastfeeding, in those with chronic stomach pain or in those at high risk of complications from an endoscopic procedure.

Reviewed by: 
Review Date: 
June 20, 2016
Last Updated:
June 27, 2016