Unique Obesity Treatment Device Gets FDA Approval
The Food and Drug Administration (FDA) has approved AspireAssist, a device that uses a surgically-placed tube to drain a portion of the stomach contents after each meal for obese patients.
AspireAssist is indicated to assist weight loss in patients aged 22 years and older who are obese, with a body mass index (BMI) 35–55, and those who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.
The device is inserted through a small incision in the abdomen into the stomach with an endoscope. A disk-shaped port valve that lies flush against the abdomen skin is connected to the tube and remains in place. About 20–30 minutes post-meal consumption, the patient attaches the external connector and tubing to the port valve, opens the valve, and drains the contents. It takes about 5–10 minutes to drain food matter through the tube and into the toilet. AspireAssist cuts approximately 30% of the consumed calories.
In a clinical trial, 111 patients were treated with AspireAssist and lifestyle therapy, and 60 control patients received only the lifestyle therapy. Patients using the device lost ~12.1% of their total body weight vs. 3.6% in the control patients after 1 year. Both patient groups also had small improvements in conditions often associated with obesity, such as diabetes, hypertension, and quality of life.
AspireAssist is not intended for patients with eating disorders or for use in short durations for patients who are moderately overweight. Patients require regular monitoring by their healthcare provider to shorten the tube length as they lose weight and abdominal girth. A safety feature on the device tracks the number of times the drain tube is connected to the port and automatically stops working after 115 cycles (about 5–6 weeks of therapy). In order to continue treatment, patients must return for a clinical visit to get a replacement part.
Reported side effects related to the use of AspireAssist include occasional indigestion, nausea, vomiting, constipation, diarrhea.
For more information call (877) 312-0007 or visit AspireBariatrics.com.