FDA approves novel obesity treatment device
The AspireAssist device has been approved for treatment of obese patients with a BMI of 35 to 55.
The FDA has approved the AspireAssist obesity treatment device for use in obese patients aged 22 years and older for whom nonsurgical weight loss therapy was ineffective.
“The AspireAssist approach helps provide more effective control of calorie absorption, which is a key principle of weight management therapy,” said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. “Patients need to be regularly monitored by their healthcare provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.”
The AspireAssist device is surgically placed in a patient's stomach using an endoscope, via a small abdominal incision. A disk-shaped port valve that lies outside the body is connected to the tube. Approximately 30 minutes after eating, patients attach the device tubing to the port valve, open the vale, and drain the contents, which takes between 5 and 10 minutes. The AspireAssist removes approximately 30% of calories consumed.
In a clinical trial of 171 patients (111 treated with the AspireAssist plus lifestyle therapy, 60 treated with lifestyle therapy only), at 1-year follow-up, patients in the AspireAssist group lost 12.1% of their total body weight, compared with 3.6% for the control patients. Additional results from clinical trials suggest that both groups saw small improvements in diabetes, hypertension, and overall quality of life.
Patients using the AspireAssist must be closely monitored by their clinician. Side effects include indigestion, nausea, vomiting, constipation, and diarrhea. The AspireAssist is not intended for short-duration use in patients who are moderately obese and should not be used in patients with eating disorders.
- FDA approves AspireAssist obesity device [news release]. Silver Springs, MD: US Food and Drug Administration. Published June 14, 2016; Accessed June 15, 2016.