Urotronic’s Optilume Urethral Drug-Coated Balloon Gets FDA Premarket Approval

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.