Bulking agent for female SUI receives approvable letter

Uroplasty, Inc. has received an approvable letter from the FDA relating to its pre-market approval application for Macroplastique implants for the treatment of female stress urinary incontinence.

The product is a soft tissue, injectable bulking agent for use in a minimally invasive, outpatient procedure. When a physician injects Macroplastique into the tissues surrounding the urethra, the increased bulk allows the urethra to close more effectively and prevents urine from leaking, the company said.