FDA Gives Thumbs Up to Aspire Bariatrics’ Obesity Device
The FDA has granted marketing approval to Aspire Bariatrics’ obesity device AspireAssist System as an endoscopic alternative to weight loss surgery for people with moderate to severe obesity.
The system approaches obesity treatment through portion control using a surgically-placed tube to drain a portion of stomach contents after every meal, removing approximately 30 percent of calories consumed.
The device consists of a tube that connects the inside of the stomach to a skin-port outside of the abdomen. After eating, the patient attaches an external connector and tubing to the skin-port, opens the port valve, and drains the food before it has been absorbed by the body.
It is intended for long-term use, in conjunction with diet and exercise, counseling and medical monitoring. The device is implanted in a 15-minute outpatient procedure, is fully reversible, and does not alter the patient’s internal anatomy.
The application was supported by a clinical trial in 111 patients who lost an average of 12.1 percent of their total body weight compared to 3.6 percent for the control group. Clinical trial results also show improvements in diabetes and hypertension.
The device labeling carries a long list of people who should not use the device, including those who have had abdominal surgery, a history of gastric ulcers, uncontrolled hypertension, a history of cardiovascular disease, anemia, pregnant or nursing, or eating disorders.
AspireAssist 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 aof 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy. — Joya Patel