Urotronic has received the US Food and Drug Administration (FDA) approval for its Optilume Urethral Drug Coated Balloon to support the treatment of male urethral strictures.
Last year, the US-based medical equipment manufacturer has secured the CE mark approval for its Optilume for the same indication.
According to the company, its Optilume drug-coated balloon technology provides a low cost, minimally invasive treatment option for men suffering from urinary tract conditions.
It serves as an alternative to traditional endoscopic treatments for conditions such as urethral strictures and benign prostatic hyperplasia (BPH).
Urotronic president and CEO David Perry said: “We are excited to introduce Optilume to the US urology community and their patients who suffer from this debilitating disease.
“The technology has the potential to reduce burdens across the US 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.”
Urethral stricture is a scar formed near urethra, that potentially restricts the flow of urine from the bladder and may result in a painful obstruction to the urinary stream.
Strictures are caused due to injury of the urethra lining, because of infections, trauma, and other medical procedures, and can impact the quality of life in patients.
It may lead to serious complications, including bladder and kidney damage, infections, and poor ejaculation in men, if left untreated.
According to the company, multiple endoscopic treatments for the stricture are found to result in worsening outcomes, recurrence, and retreatment.
Optilume technology was developed in response to patient and physician dissatisfaction with current endoscopic solutions for urethral strictures.
It works by dilating the urethral lumen and delivers paclitaxel directly to the stricture, to inhibit the recurrence of new scar tissue, post-endoscopic dilations.
The device was assessed in Re-establishing Flow Via Drug-Coated Balloon for the Treatment of Urethral Stricture Disease (ROBUST) study.
ROBUST trials principal investigator Sean Elliott said: “As the ROBUST 1 and ROBUST 3 clinical trials demonstrated, Optilume significantly reduces the incidence of stricture recurrence.
“At three years, durability continued with a 77% freedom from reintervention rate, a 176% increase in Qmax, and a 65% decrease in IPSS.
“Optilume may serve as an important alternative for men with recurrent strictures that want to avoid or delay urethroplasty.”
