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.
Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, according to Urotronic. Meanwhile, the delivery of paclitaxel aims to maintain luminal patency during healing.
“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming or implants,” said Urotronic President and CEO David Perry. “This advancement, backed by strong clinical outcomes, has the potential to improve the quality of life for millions of patients looking for a solution for BPH and its associated lower urinary tract symptoms. Drug-coated balloons are the future of interventional urology.”
The minimally invasive outpatient procedure alleviates urinary symptoms caused by BPG. Urotronic says its drug-coated balloon technology creates a paradigm change from the methods currently used by urologists to treat these conditions.
“With the highest reported Qmax in BPH MIST trials to date, Optilume BPH is the next generation of minimally invasive technology, creating a new drug-device space among BPH therapies,” said Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York. “The positive data from the PINNACLE and EVEREST trials demonstrates clear and compelling sustained clinical outcomes through four years post-treatment,” said Dr. Kaplan.[1],[2]
