Laborie Unveils Positive Study Results for Optilume® BPH Catheter System
13 May 2024
Clinical ResultDrug Approval
PORTSMOUTH, N.H., May 13, 2024 /PRNewswire/ -- Laborie Medical Technologies Corp. (Laborie), a leading diagnostic and therapeutic medical technology company, announced positive 2-year and 5-year results from studies for its Optilume® BPH Catheter System. Details from the studies were shared during presentations at the AUA Annual Meeting (American Urologic Association) held in San Antonio, TX, on May 3-5, 2024, by Steven A. Kaplan, MD, FACS, of Mount Sinai Health System and AUA's Research Council Chair.
The Optilume® BPH Catheter System is a unique minimally invasive surgical therapy (MIST) that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel for treating lower urinary tract symptoms (LUTS) secondary to BPH.
Dr. Kaplan, Director of the Men's Wellness Program at Mount Sinai Health System and Principal investigator for the Optilume® BPH Catheter System PINNACLE trial, presented 2-year data from the PINNACLE study and 5-year data from the EVEREST study. The results show a sustained Qmax (Maximum Urinary Flow Rate) of 19.0mL/seconds at 2 years, vs. 19.0 mL/sec at 12m, and a 53% decrease in International Prostate Symptom Score (IPSS). For the 5-year EVEREST study, results show an improved Qmax of 20.6mL/sec and an IPSS decrease of 10.2 points vs. baseline, with a 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, "The long-term results from both trials show positive outcomes for men suffering from BPH who undergo this minimally invasive procedure."
"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."
Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on Urology, Interventional Urology, Urogynecology, Gastroenterology, Obstetrics, Gynecology & Neonatal Health. We manufacture and deliver high-quality, high-impact diagnostic and therapeutic products that help clinicians and hospitals preserve and restore patient dignity. Clinicians and hospitals look to us as the market-leading experts in our business segments, and we support our products with a world-class clinical education & information program. Laborie is a portfolio company of Patricia Industries. For more information, visit
www.laborie.com.
SOURCE Laborie Medical Technologies
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