Optilume® Urethral Drug-coated Balloon
A cutting edge solution to solve the dissatisfaction in current stricture solutions
A cutting edge solution to solve the dissatisfaction in current stricture solutions
The Optilume® urethral drug-coated balloon was developed in response to severe patient and physician dissatisfaction with current stricture solutions.
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*36F is currently only approved for use in the United States
**Rated Burst Pressure
***36Fr Optilume Urethral Drug Coated Balloon is not compatible with flexible cystoscopes.
The Optilume® procedure is similar to traditional mechanical dilation methods, making it simple to learn and perform. The semi-compliant balloon mechanically dilates and expands the urethral lumen, creating micro-fissures in the urothelium which facilitate circumferential drug delivery across the length of the urethral stricture. By combining simple and effective balloon dilation with localized delivery of a proven antiproliferative drug3 – The Optilume® Urethral Drug Coated Balloon provides long-term relief from stricture recurrence.1,2
Custom sizing to individual patient prostatic anatomy for optimal outcomes.
Insert drug-coated balloon into the urethral lumen.
The balloon expands the lumen, creating microfissures in the tissue.
The balloon’s coating releases paclitaxel directly into the fissured tissue. Paclitaxel is absorbed by the urothelium, where it resides through 28 days, reducing cell proliferation and fibrotic scar tissue generation.
The Optilume® technology combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency.
The semi-compliant balloon expands the tissue creating a mechanical balloon dilation effect rupturing the urethral mucosa and allowing direct, circumferential drug delivery to the exposed submucosa through micro-fissures across the length of the stricture.1,2
Rapid uptake of the highly lipophilic drug, paclitaxel, limits hyperactive cell proliferation and the fibrotic scar tissue generation that results in stricture recurrence.
By combining simple and effective balloon dilation with localized delivery of a proven antiproliferative drug3, the Optilume® technology provides superior results vs standard of care endoscopic management.1,2
*36F is currently only approved for use in the United States
**Rated Burst Pressure
***36Fr Optilume Urethral Drug Coated Balloon is not compatible with flexible cystoscopes.
At 5 years, durability continued with 72% FFRI* 1, with a 298% increase in Qmax* (Baseline 5mL, 5-year 19.9mL)¹ and a 71 decrease in IPSS* (Baseline 22.5, 5-year 7.2).¹ Qmax & IPSS are using FCF* rates – Includes worst observed value carried forward for subjects undergoing repeat intervention of the study stricture (i.e. clinical failures).
*Qmax = Maximum Urinary Flow Rate
*FFRI = Freedom From Repeat Intervention (inc. self-catheterization)
*IPSS = International Prostate Symptom Score
*FCF = Failure Carried Forward
Simple | Easily achieve relief
Safe | Proven on a difficult patient population1,2
Durable | The breakthrough treatment to break the stricture cycle
For patients who have failed prior endoscopic treatment, today there is Optilume® — a breakthrough urethral drug-coated balloon treatment that dilates the urethral lumen and delivers paclitaxel directly to the stricture, significantly reducing the incidence of stricture recurrence.1,2
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1. DeLong J, et al. Outcomes of Bulbar Urethral Stricture Treatment With Optilume: ROBUST I Study Results. J Urol. 2025 Jan;213(1):90-8.
2. Srikanth, P., DeLong, J., Virasoro, R., & Elliott, S. P. (2025). A drug-coated balloon treatment for urethral stricture disease: Three-year results from the ROBUST III study. Journal of Endourology, 39(5), 567–574.
3. Rosenfield K, Jaff MR, White CJ, et al. Trial of Paclitaxel-Coated Balloon for Artery Disease. NEJM 2015;372(2):145-53
MKT-00546 [B]
Manufactured by Urotronic, Inc. Please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. The Optilume DCB is indicated for use in patients with obstructive urinary symptoms associated with anterior urethral stricture. It is designed to be used in adult males for urethral strictures of ≤3cm in length. The Optilume DCB is contraindicated for patients with known hypersensitivity to paclitaxel or structurally related compounds and patients with urologic implants such as penile implants or artificial urinary sphincters. Paclitaxel may be present in semen after treatment with the Optilume DCB. The risks associated with paclitaxel in semen and the impact on sperm and spermatogenesis are unknown. Men should abstain or use a condom for 30 days and men with partners of child-bearing potential should use highly effective contraceptive and avoid fathering children for 6 months after treatment. Monitor for signs of anaphylaxis or hypersensitivity to paclitaxel. Potential risks can include, but are not limited to, the following: blood in the urine (hematuria), painful urination (dysuria), urinary tract infection (UTI), urinary retention, and stricture recurrence.
