Aspire Bariatrics is closing all operations and, as a consequence, is withdrawing the controversial AspireAssist from the market, effective April 2022, due to the financial impact of the COVID-19 pandemic.
“Our withdrawal of the AspireAssist from the market is entirely the result of economic factors, not the result of safety or effectiveness issues associated with or reported with the product,” the company said in a statement.
The AspireAssist system consisted of a low-profile implantable gastrostomy tube and a siphon system. Patients drain the contents of their stomachs after a meal, thereby reducing caloric absorption. The system was indicated for patients with a BMI35-55, aged 22 or older and who failed to achieve weight loss using nonsurgical means.
The device was approved by the FDA and was endorsed by the ASMBS for patients with BMIs in excess of 40 or for patients who need a long-duration treatment in May 2016. Nevertheless, the device was criticised by bariatric surgeons and obesity specialists alike as the "bulimia assisted device".