FDA Approves AspireAssist Obesity Device

Aspire Bariatrics

On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.  According to a press release by the manufacturer Aspire Bariatrics, the AspireAssist System is an endoscopic alternative to weight loss surgery for people with moderate to severe obesity and is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies.

The FDA news release summarized the procedure of installing and using AspireAssist as follows:

To place the [AspireAssist] device, surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen.  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.

AspireAssist

According to the FDA news release, 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.  The lifestyle therapy included nutrition and exercise counseling.  After one year, patients who used AspireAssist lost an average of 12.1 percent of their 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 often associated with obesity, such as diabetes, hypertension and quality of life.

A youtube video on the AspireAssist System published by Aspire Bariatrics is attached below:

 

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