UROPLASTY SUBMITS TWO PRODUCTS FOR FDA CLEARANCE
Uroplasty, a medical device company that develops, manufactures and markets products for the treatment of voiding dysfunctions, has submitted requests to the FDA for 510(k) clearance to market two new products: the Urgent PC Neuromodulation System and the I-STOP Mid-Urethral Sling System.
The Urgent PC Neuromodulation System is a minimally invasive nerve stimulation device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. The product delivers an electrical pulse that travels to the sacral nerve plexus, a control center for bladder function, using percutaneous tibial nerve stimulation.
Uroplasty's I-STOP Mid-Urethral Sling System is a biocompatible, tension-free sling for the treatment of stress urinary incontinence resulting from urethral hypermobility, a condition in which the urethra is not properly supported by surrounding tissues.