Aspire Bariatrics® Inc. has received FDA approval for the AspireAssist weight loss device in June 2016.
The AspireAssist resembles a large PEG tube. It consists of a tube that connects the inside of the stomach to a port (Skin-Port) outside of the abdomen. After eating, the patient attaches an external connector and tubing to the port, opens the port valve, and drains the food. The device is aimed to be used after each of the three daily meals. The stomach contents are drained by gravity into a toilet or other receptacle.
The AspireAssist is FDA approved for use in adults who are at least 22 years old with a Body Mass Index (BMI) of 35.0-55.0 kg/m2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy.
The pivotal trial providing the basis for FDA approval consisted or a randomized control trial with 111 treatment and 60 control patients, with a one year follow up. The %EWL for Treatment Subjects was 31.5% vs. 9.8% for Control Subjects at one year.
SAGES Technology & Value Assessment Committee
Tech Alert, March 2015
By Dan Azagury, MD
