FDA approves home stomach pump to combat obesity

Brittany A. Roston - Jun 16, 2016, 1:36pm CDT
FDA approves home stomach pump to combat obesity

This week, the Food and Drug Administration announced its approval of a stomach-draining device called AspireAssist; it is designed to combat obesity via a drainage tube and port implanted in the patient’s stomach, allowing the patient to drain some of their stomach contents after they eat. When used properly, the device will drain about 30-percent of a meal’s calories, according to the FDA, essentially serving as an alternative to lap band surgeries.

The device works as shown in the video below. The patient undergoes a minor surgery under twilight anesthesia; the doctor places a “disk-shaped port valve” on the outside of the stomach, as well as a drainage tube that is behind the port and inside of the stomach. The drainage tube is arranged in such a way that it can only drain a portion of the stomach’s contents.

The patient must be careful to thoroughly chew their food to avoid potential blockages in the drainage tube. Between 20 and 30 minutes after eating, the patient attaches the AspireAssist device to the stomach port, then opens the valve so that the stomach contents can drain out into a toilet. This process takes up to 10 minutes.

The device is designed with some safety mechanisms to prevent abuse — namely, it works for 115 “cycles” after which the patient has to get a part replaced for it to be functional again. The FDA warns that it does come with some side effects, including things like feeling nauseous and vomiting. The biggest risk appears to be the possibility of an opening remaining after the stomach port is removed.

The AspireAssist device has gone through testing, including a clinical trial involving 111 patients and 60 control patents. Those with the device lost an average of 12.1-percent of their body weight after one year, whereas the control patients lost an average of 3.6-percent.

SOURCE: FDA


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