FDA Approves AspireAssist Device to Treat Obesity

June 15, 2016
FDA News Release

FDA Approves AspireAssist Device to Treat Obesity

The FDA has approved a surgically implanted weight-loss device that drains the contents of the stomach after meals. The AspireAssist device is intended for those aged 22 and older with a body mass index of 35 to 55.

In a clinical trial of 111 patients, those who used the AspireAssist device plus lifestyle therapy for 1 year lost an average of 12% of their body weight, versus 4% among those who underwent lifestyle therapy alone.

A surgeon first uses an endoscope to insert a tube in the stomach. The tube then connects, through a small incision in the abdomen, to an external port valve that lies against the skin of the abdomen. Roughly 20–30 minutes after eating a meal, the patient attaches the device’s external connector and tubing to the port valve, opens the valve, and drains the contents of the stomach into the toilet. The process takes about 5–10 minutes; approximately 30% of calories consumed are drained.

Patients using the device require frequent monitoring. In addition, the device shuts off automatically after 115 cycles (5–6 weeks), after which the patient must see their healthcare provider for a replacement part that allows treatment continuation.

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FDA Approves AspireAssist Device to Treat Obesity