Urethral Stricture

PORTSMOUTH, N.H., Jan. 17, 2025 /PRNewswire/ -- Laborie Medical Technologies Corp. (Laborie), a leader in diagnostic and therapeutic medical technologies, has reached a significant milestone with its Optilume® Drug-Coated Balloon (DCB). The groundbreaking treatment for recurrent bulbar urethral strictures has had its five-year follow-up data from the ROBUST I study published in the Journal of Urology. This data underscores the durability, safety, and efficacy of Optilume as a minimally invasive option for patients. The study evaluated 53 men with recurrent bulbar strictures, concluding that 71.7% of patients did not need repeat intervention. Additionally, the average International Prostate Symptom Score (IPSS) improved from a mean of 25.2 at baseline to 7.2 at five years (p<0.001). The maximum flow rate improved from 5.0 mL/s at baseline to 19.9mL/s (P < .01), and average postvoid residual was reduced from 141.4 mL to 59.5 mL (P < .01). Erectile function was unaffected, and there were no serious treatment-related adverse events. "Optilume DCB is a transformative addition to the treatment algorithm for stricture patients," said Dr. Allen F. Morey, M.D., FACS. "With the robust 5-year clinical data, we now see its ability to provide durable, long-term relief. It remains an excellent option for elderly patients or those with comorbidities who are suboptimal candidates for open surgery and for enhancing outcomes in complex stricture management." The Optilume DCB combines mechanical dilation with the localized delivery of paclitaxel, a drug that inhibits tissue regrowth, directly to the urethral tissue. This dual-action approach limits scar tissue formation, breaking the cycle of stricture recurrence. It also provides a less invasive and faster recovery alternative to urethroplasty. The ROBUST I data strengthens the evidence base for Optilume, complementing findings from randomized controlled trials such as ROBUST III, demonstrating superior outcomes over the standard of care for recurrent anterior urethral strictures. For more information on Optilume and its role in transforming the treatment of urethral stricture disease, visit . About Laborie Medical Technologies Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on 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  . SOURCE Laborie Medical Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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." Optilume Stricture received FDA and CE approval. Optilume BPH is approved by the FDA and CFIA (Canada). For more information, visit Optilume.com or Optilume.com/BPH. About Laborie Medical Technologies 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  . SOURCE Laborie Medical Technologies

PORTSMOUTH, N.H., April 30, 2024 /PRNewswire/ -- Laborie Medical Technologies Corp. (Laborie), a leading diagnostic and therapeutic medical technology company, welcomed the inclusion of Optilume® Urethral Drug-Coated Balloon (DCB) into the National Health Service (NHS) Specialized Services Device Programme (SSDP) as of April 1, 2024. This national payment scheme ensures NHS Hospitals in England will be reimbursed for the cost of the Optilume Urethral DCB, enabling patients to benefit from wider access to the technology. The SSDP, formerly the High-Cost Tariff Excluded Devices programme (HCTED), reimburses innovative healthcare technologies that meet specific clinical and economic criteria separately from the core payment mechanism for medical treatments and interventions in the NHS. Optilume® Urethral DCB combines balloon dilation of the urethra with the delivery of an anti-proliferative drug to prevent the recurrence of urethral strictures. This minimally invasive technology is expected to have a significant impact in the urology community, offering a breakthrough treatment option for urethral strictures that would traditionally require major surgery or need frequent retreatment1. "The Optilume Urethral DCB has been clinically and economically proven through randomized clinical trials and economic evidence2,3,4, and has been evaluated by the National Institute for Health and Care Excellence (NICE)," said Kyle Knauf, Vice President and General Manager of Interventional Urology at Laborie. In November 2022, Optilume received National Institute for Health and Care Excellence (NICE) guideline recommendations that it is safe, effective, and cost saving to use in clinical practice in the NHS for the treatment of anterior urethral stricture, providing improved clinical and economic benefits to patients versus the existing endoscopic standard of care5. "The inclusion as part of national funding provides all clinically eligible patients in England access to treatment that is a more clinically effective and durable solution while providing cost efficiencies to the NHS," Knauf continued. "We look forward to continuing to provide the NHS and its patients with clinically proven technologies that preserve and restore human dignity." About Laborie Medical Technologies Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on 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 . References Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol. 1998 Aug;160(2):356-8. doi: 10.1016/s0022-5347(01)62894-5. PMID: 9679876. VanDyke ME, Morey AF, Coutinho K, Robertson KJ, D'Anna R, Chevli K, et al. Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial. BJUI Compass. 2024; 5(3): 366–373. Mann, Rachel; Delong, Jessica; Virasoro, Ramon; Elliott, Sean PD35-08 4 YEARS OF THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: A SUMMARY OF ROBUST I, II AND III, Journal of Urology: April 2023 - Volume 209 - Issue Supplement 4 Kelly L, Shore J, Wright J, Patrick C, Holmes H. Economic evaluation of Optilume, a drug-coated balloon for recurrent anterior male urethral stricture. BJUI Compass. 2023 Apr 10;4(4):430-436. Optilume for treating recurrent bulbar urethral strictures (MTG73). ISBN: 978-1-4731-4803-1. SOURCE Laborie Medical Technologies