FDA approves drug-coated balloon for BPH symptoms from Urotronic

The Optilume BPH catheter system drug-coated balloon. [Image courtesy of Urotronic]Urotronic announced that the FDA approved its Optilume BPH catheter system for to alleviate urinary symptoms caused by BPH.

Minneapolis-based Urotronic designed Optilume as a minimally invasive surgical therapy. It combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel. This treats lower urinary tract symptoms secondary to BPG (benign prostatic hyperplasia).

Urotronic previously received FDA approval Optilume for the treatment of male urethral strictures. In these cases, the balloon inhibits new scar tissue growth that can occur after endoscopic dilations.

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Laborie acquires exclusive license for drug-coated baloon treatment for urethral strictures

Laborie Medical Technologies announced today that it acquired an exclusive license to the Optilume urethral drug-coated balloon (DCB).

Portsmouth, New Hampshire-based Laborie purchased a perpetual, exclusive license to Optilume — developed by Urotronic — following FDA approval in December 2021. The DCB platform received CE mark approval for use in male anterior urethral strictures in 2020.

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FDA approves Urotronic’s Optilume drug coated balloon for urethral strictures

Urotronic today announced that it received FDA approval for its Optilume urethral drug coated balloon for male urethral strictures.

Minneapolis-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 the flow of urine from the bladder.

Get the full story on our sister site, Medical Tubing + Extrusion.

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