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Optilume Drug-Coated Balloon Shows Long-Term Efficacy for Urethral Strictures: Five-Year Data Published in the Journal of Urology


News provided by

Laborie Medical Technologies

Jan 17, 2025, 07:30 ET

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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 www.optilume.com.

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  www.laborie.com.

SOURCE Laborie Medical Technologies

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