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December 14, 2021updated 07 Jan 2022 8:38am

FDA approves Urotronic’s drug coated balloon to treat urethral strictures

The device delivers paclitaxel directly to the stricture to inhibit new scar tissue growth.

The US Food and Drug Administration (FDA) has approved the Urotronic Optilume Urethral Drug Coated Balloon to treat urethral strictures in males.

The new Optilume technology is developed for patients and physicians that are not satisfied with the current solutions available for the treatment of urethral strictures.

It serves as an alternative to traditional endoscopic stricture treatments for men suffering from urethral strictures.

Dilating the urethral lumen, the Optilume technology supplies paclitaxel directly to the stricture, which inhibits the recurrence of new scar tissue growth following endoscopic dilations.

The company noted that its technology provides a low cost, durable and minimally invasive therapeutic option for men with urinary tract 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 strictures are scars that occur in or around the urethra and can block urine flow from the bladder.

Strictures can occur due to trauma, infections and other medical procedures that hurt the urethra lining.

They can lead to serious complications, including infections, poor ejaculation in men, and damage to the bladder and kidneys.

Last year, the company secured CE mark approval for its Optilume device to treat urethral strictures.

Additionally, the technology was evaluated in the Re-establishing Flow Via Drug-Coated Balloon for the Treatment of Urethral Stricture Disease (ROBUST) clinical studies.

ROBUST trials principal investigator Dr 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 International Prostate Symptom Score (IPSS).

“Optilume may serve as an important alternative for men with recurrent strictures that want to avoid or delay urethroplasty.”

Last October, Laborie Medical Technologies and Urotronic signed a definitive agreement to enter into a multi-faceted, strategic partnership.

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