Optilume® Urethral Drug Coated Balloon for the treatment of Anterior Urethral Stricture

Optilume® Urethral Drug Coated Balloon for the treatment of Anterior Urethral Stricture

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A Safe, Simple and Durable Treatment for Urethral Stricture

Break the stricture cycle

The Optilume® urethral drug-coated balloon was developed in response to severe patient and physician dissatisfaction with current stricture solutions.

A Cutting Edge Solution to Solve the Dissatisfaction in Current Stricture Solutions

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

Rapid uptake of the highly lipophilic drug, paclitaxel, limits hyperactive cell proliferation and the fibrotic scar tissue generation that results in stricture recurrence.

Providing Superior Results to Traditional Urethral Stricture Management

By combining simple and effective balloon dilation with localized delivery of a proven antiproliferative drug², the Optilume® technology provides superior results vs standard of care endoscopic management.³

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MKT-00546 [A]

How durable are the outcomes?

At 3 years, durability continued with 77% FFRI* ¹, with a 176% increase in Qmax* (Baseline 5.1, 3-year 14.1) and a 65% decrease in IPSS* (Baseline 25.2, 3-year 8.8). 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).

optilume outcomes*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 population³

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.³

Request more information or arrange a demonstration of the Optilume® Urethral Drug Coated Balloon

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How Optilume® Works

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 drug² – The Optilume® Urethral Drug Coated Balloon provides long-term relief from stricture recurrence¹.

  • Procedure Type: Anterior Urethral Stricture Treatment
  • Balloon Lumen: Selection of 18Fr, 24Fr, 30Fr and 36Fr*. (fully inflated to appropriate RBP**)
  • Balloon Length(s): 3cm for treating strictures <2cm, 5cm for treating strictures <3cm
  • Guidewire compatibility: Yes, 0.035” and/or 0.038”
  • Single use/disposable
  • Latex free
  • Inflation device provided
  • For use with rigid or flexible cystoscopy***
  • Can be used with flouroscopy imaging and/or direct visualization

*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.

¹Elliott SP, Virasoro R, Estrella R, et al. MP56-06 The Optilume Drug Coated Balloon for Recurrent Anterior Urethral Strictures: ROBUST I Clinical Study 3-year follow up, N = 43. J Urol 2021;206(3S):e971.

²Rosenfield K, Jaff MR, White CJ, et al. Trial of Paclitaxel-Coated Balloon for Artery Disease. NEJM 2015;372(2):145-53

³Elliott SP, Coutinho K, Robertson KJ, D’Anna R, Chevli K, Carrier S, Aube-Peterkin M, Cantrill CH, Ehlert MJ, Te AE, Dann J, DeLong JM, Brandes SB, Hagedorn JC, Levin R, Schlaifer A, DeSouza E, DiMarco D, Erickson BA, Natale R, Husmann DA, Morey A, Olsson C and Virasoro R, One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume Drug-Coated Balloon for Anterior Urethral Strictures, The Journal of Urology® (2021), doi: 10.1097/JU.0000000000002346

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.

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