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FDA Approves Optilume® Urethral Drug Coated Balloon

FDA Approves Optilume® Urethral Drug Coated Balloon

Urotronic, Inc., a Minnesota based medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Optilume® Urethral Drug Coated Balloon for use in male urethral strictures. Optilume was granted CE mark approval for use in urethral strictures in 2020.

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, frustrating slowing of the urinary stream. Strictures can be caused by infections, trauma, and other medical procedures that injure the lining of the urethra and can significantly impact patients’ quality of life. If left untreated, strictures can lead to serious complications, including bladder and kidney damage, infections, and poor ejaculation in men. Multiple endoscopic treatments of the same stricture are proven to lead to progressively worsening outcomes, recurrence, and retreatment.2

The Optilume paclitaxel-coated balloon technology was developed in response to patient and physician dissatisfaction with current endoscopic solutions for urethral strictures. Optilume works by inhibiting new scar tissue growth that often recurs after endoscopic dilations. This innovative, proprietary technology represents a significant paradigm change from the methods currently used by urologists to treat these conditions and provides a durable, low-cost, minimally invasive treatment option for millions of patients suffering from these conditions globally. Patients who suffer from urethral stricture undergo millions of dilations per year in the US alone.³

“As the ROBUST 1 and ROBUST 3 clinical trials demonstrated, Optilume significantly reduces the incidence of stricture recurrence,” said Dr. Sean Elliott, principal investigator for the Re-establishing Flow Via Drug-Coated Balloon for the Treatment of Urethral Stricture Disease (ROBUST) trials. “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”.4

David Perry, President and CEO of Urotronic, Inc. stated, “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.” https://optilume.com/

  1. Elliott SP, et al. MP56-07: Interim Results for the ROBUST III Trial Evaluating the Optilume Drug Coated Balloon for Anterior Urethral Strictures. J Urol 2021;206(3S):e971.
  2. Heyns CF, Steenkamp JW, De Kock MLS, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol 1998;160:356-8.
  3. Santucci, RA Male Urethral Stricture Disease J Urol. 2007, May
  4. Data on file
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