USFDA approves Optilume Urethral Drug Coated Balloon

Urotronic, Inc., a Minnesota based medical device company, 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.2Optilume Urethral Drug Coated Balloon approved by FDA.

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FDA Approves Optilume Urethral Drug Coated Balloon for urethral strictures