Uroplasty's SUI (stress urinary incontinence) product nears the US:
This article was originally published in Clinica
The US FDA has issued Uroplasty with an approvable letter for its Macroplastique implants for treating female stress urinary incontinence (SUI), subject to the agency completing its auditing of the firm's manufacturing facilities, methods and controls. Since its introduction in Europe, over 60,000 people have been treated with Macroplastique, which is a soft tissue, injectable bulking agent for use in a minimally-invasive, out-patient procedure. In the US, SUI affects around 13 million people, 85% of whom are women, said the Minnetonka, Minnesota company.