Premarket approval for AMS' (American Medical Systems) UroLume endoprosthesis:
This article was originally published in Clinica
Executive Summary
American Medical Systems has received US FDA approval to market its UroLume endoprosthesis, a braided wire mesh stent for treating detrusor-external sphincter dyssynergia (DESD), a urologic condition caused by spinal cord injuries. The UroLume is inserted in the urethra of these patients, who suffer a lack of co-ordination between the bladder and the urinary sphincter, leading to the bladder not being emptied completely. AMS of Minneapolis, Minnesota, had received approval for the UroLume in October 1996 for treating benign urethral stricture disease in men (see Clinica No 129, p 17).