Urotronic, Inc. today announced the presentation of positive data from two clinical trials evaluating the Optilume® BPH System’s effectiveness and durability in treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
| Dr. Steven A. Kaplan presented positive 4-year and 12-month clinical outcomes during the American Urological Association’s Annual Meeting MINNEAPOLIS, May 1, 2023 /PRNewswire/ -- Urotronic, Inc., a Minnesota-based medical device company pioneering the application of its drug-coated balloon technology for use in interventional urology, today announced the presentation of positive data from two clinical trials evaluating the Optilume® BPH System’s effectiveness and durability in treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Four-year and 12-month data from the EVEREST and PINNACLE clinical trials were presented by Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York and the principal investigator of the two studies, during the American Urological Association’s (AUA) Annual Meeting in Chicago.
“The positive data from the PINNACLE and EVEREST trials – including the highest reported Qmax in BPH MIST trials to date – demonstrates clear and compelling sustained clinical outcomes through four years post-treatment,” said Dr. Kaplan. “Optilume BPH is not your grandfather’s BPH balloon – it’s the next generation of minimally invasive technology, creating a new drug device space among BPH therapies.” Optilume BPH 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 the treatment of 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. “The PINNACLE Trial: 12-Month Report from a Randomized, Double-Blind, Sham Controlled Study” and “At 4 Years, Optilume BPH Has the Highest Sustained Improvement in Peak Flow (Qmax) of Any Minimally Invasive BPH Therapy,” both presented by Dr. Kaplan during the AUA Annual Meeting, demonstrated positive outcomes including:
“Backed by positive clinical data, ease of use and ability to be performed in an office setting, we believe this groundbreaking therapy has the potential to change the way BPH is treated, establishing a new standard of care to improve the quality of life for millions of men struggling with LUTS caused by BPH,” said David Perry, Urotronic president and CEO. The PINNACLE trial is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System with 148 patients randomized in a 2:1 fashion at 18 centers in the U.S. and Canada. Subjects and evaluating personnel were blinded to the treatment received through 12 months. The EVEREST trial is a prospective, single arm, multicenter study evaluating functional improvement in urine flow and improvement in LUTS after treatment with the Optilume BPH System. Eighty patients were enrolled at six centers with four-year follow-up complete. Optilume BPH is an investigational device in the U.S. and is pending Food and Drug Administration (FDA) premarket approval; the device is approved for sale in Canada and Israel. The Optilume Urethral Drug Coated Balloon for use in male urethral strictures, which applies the same technology, was granted U.S. FDA approval in December 2021 and received CE Mark in September 2020. About Urotronic, Inc. Media Contact
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