Thursday, 16 June 2016
FDA approves novel stomach-emptying device to treat obesity
The FDA has added a fourth kind of obesity treatment device to its roster of approved interventions. The agency has approved the AspireAssist System from Pennsylvania-based start-up Aspire Bariatrics. The device works to drain part of the stomach contents after each meal via a surgically place tube.
This stomach-emptying approach adds to the two gastric bands, two balloon-based, stomach-filling systems and one neurostimulator that are already approved by the FDA. In a 111-patient pivotal trial, after one year of use patients using AspireAssist and receiving lifestyle therapy lost an average of 12.1% of their total body weight, as compared with a control group receiving lifestyle therapy alone, who lost only 3.6%.