FDA approves AspireAssist Aspiration Therapy System for obesity- Aspire Bariatrics

The FDA has approved AspireAssist device, from Aspire Bariatrics, an obesity treatment that uses a surgically-placed tube to drain a portion of the stomach contents after every meal. The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight. It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.

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. 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 often associated with obesity, such as diabetes, hypertension and quality of life. These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling.

Comment: With Aspiration Therapy, patients “aspirate” (drain) a portion of their stomach contents into the toilet after each meal through an endoscopically-implanted tube, reducing the number of calories absorbed by the body. The tube is implanted in the stomach, and leads to a small, low-profile port at the surface of the skin. Aspiration performed about twenty minutes after a meal will remove about a third of the calories consumed.