Urotronic today announced that it received FDA approval for its Optilume urethral drug-coated balloon for male urethral strictures.
Plymouth, Minnesota–based Urotronic designed the paclitaxel-coated balloon to inhibit new scar tissue growth that can occur after endoscopic dilations. Urethral strictures are scars in or around the urethra that can restrict urine flow from the bladder.
According to its Robust 1 and Robust 3 clinical trials, Optilume has been shown to significantly reduce stricture recurrence, according to the company. At three years, patients had a 77% freedom from reintervention rate, a 176% increase in Qmax and a 65% decrease in IPSS.
“We are excited to introduce Optilume to the U.S. urology community and their patients who suffer from this debilitating disease. The technology has the potential to reduce burdens across the U.S. healthcare landscape as a treatment that is easy to learn and can be performed as an outpatient procedure. Optilume is the treatment that breaks the cycle of recurrent urethral strictures,” president and CEO David Perry said in a news release.