FDA approves Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH

Mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing.

“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.

“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.”