Urotronic PMA Approved for Urethral Strictures

FDA has approved an Urotronic PMA for Optilume Urethral Drug Coated Balloon for use in male urethral strictures. Optilume is designed as an alternative to traditional endoscopic stricture treatments. It dialates the urethral lumen and delivers paclitaxel directly to the stricture, significantly reducing the incidence of stricture recurrence, according to the company. A urethral stricture is a scar in or around the urethra that can restrict the flow of urine from the bladder and can result in a painful and slow urinary stream, according to the company.

Urotronic says Optilume works by inhibiting new scar tissue growth that often recurs after endoscopic dilations. The device’s approval was based on data from the ROBUST 1 and ROBUST 3 clinical trials, which demonstrated the device significantly reduces the incidence of stricture recurrence, Urotronic says.