Sam Brusco, Associate Editor05.13.24
Laborie Medical revealed positive two-year and five-year results from studies of its Optilume BPH (benign prostatic hyperplasia) catheter system.
For the two-year PINNACLE study, sustained Qmax (maximum urinary flow rate) of 19 mL/seconds at two years vs. 19 mL/sec at 12 minutes. There was also a 53% decrease in International Prostate Symptom Score (IPSS).
For the five-year EVEREST study, results show an improved Qmax of 20.6mL/sec and an IPSS decrease of 10.2 points vs. baseline, with retreatment rate of 3.8% (1.3% surgical and 2.5% medical). There was no reported impact on sexual function from either study.
"Optilume for BPH is an exciting therapy that offers a safe, effective, and minimally invasive procedure for men suffering from BPH," remarked Dr. Kaplan, Director of the Men's Wellness Program at Mount Sinai Health System and principal investigator for the PINNACLE trial. "The long-term results from both trials show positive outcomes for men suffering from BPH who undergo this minimally invasive procedure."
Optilume BPH is a minimally invasive surgical therapy that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized paclitaxel delivery for treating lower urinary tract symptoms secondary to BPH. Laborie acquired the Optilume catheter from Urotronic in a 2023 acquisition deal.
"Laborie's mission is to preserve and restore human dignity, and we do that in large part by providing clinically effective, safe, and durable treatment options," said Michael Frazzette, Laborie's president and CEO. "Optilume for Anterior Urethral Stricture and Optilume for BPH are game changers for clinicians and their patients, and we're pleased to see this reflected in the recent clinical findings presented at the AUA Annual Meeting."
For the two-year PINNACLE study, sustained Qmax (maximum urinary flow rate) of 19 mL/seconds at two years vs. 19 mL/sec at 12 minutes. There was also a 53% decrease in International Prostate Symptom Score (IPSS).
For the five-year EVEREST study, results show an improved Qmax of 20.6mL/sec and an IPSS decrease of 10.2 points vs. baseline, with retreatment rate of 3.8% (1.3% surgical and 2.5% medical). There was no reported impact on sexual function from either study.
"Optilume for BPH is an exciting therapy that offers a safe, effective, and minimally invasive procedure for men suffering from BPH," remarked Dr. Kaplan, Director of the Men's Wellness Program at Mount Sinai Health System and principal investigator for the PINNACLE trial. "The long-term results from both trials show positive outcomes for men suffering from BPH who undergo this minimally invasive procedure."
Optilume BPH is a minimally invasive surgical therapy that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized paclitaxel delivery for treating lower urinary tract symptoms secondary to BPH. Laborie acquired the Optilume catheter from Urotronic in a 2023 acquisition deal.
"Laborie's mission is to preserve and restore human dignity, and we do that in large part by providing clinically effective, safe, and durable treatment options," said Michael Frazzette, Laborie's president and CEO. "Optilume for Anterior Urethral Stricture and Optilume for BPH are game changers for clinicians and their patients, and we're pleased to see this reflected in the recent clinical findings presented at the AUA Annual Meeting."