www.fdanews.com/articles/205850-urotronics-optilume-urethral-drug-coated-balloon-gets-fda-premarket-approval
Urotronic’s Optilume Urethral Drug-Coated Balloon Gets FDA Premarket Approval
December 20, 2021
Urotronic has received the FDA’s premarket approval for its Optilume urethral drug-coated balloon for treatment of male urethral strictures.
A urethral stricture is a scar that can restrict the flow of urine from the bladder and can result in a painful slowing of the urinary stream and other complications.
The Minneapolis, Minn.-based company said it developed Optilume, which includes a balloon coated with the cancer drug paclitaxel, in response to patient and physician dissatisfaction with current endoscopic solutions for urethral strictures.
Optilume gained a CE mark for the indication in 2020.