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A breakthrough treatment to break the cycle of recurring urethral strictures

For patients who have failed prior endoscopic management, today there is Optilume® — a breakthrough drug-coated balloon treatment that dilates the urethral lumen and delivers paclitaxel directly to the stricture, significantly reducing the incidence of stricture recurrence.*

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*Elliott SP, et al. Interim Results for the ROBUST III Trial Evaluating the Optilume Drug Coated Balloon for Anterior Urethral Strictures. 36th Annual EAU Congress; 2021

How durable are the outcomes?

3-year data*

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At 3 years, durability continued with 77% FFRI, 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).

*Elliott SP,  et al. The Optilume Drug Coated Balloon for recurrent anterior urethral strictures: 3-year results for the ROBUST I study. 36th Annual EAU Congress; P0392; 2021

How it works

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All this in a simple out-patient procedure

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Until now, there has been no treatment for urethral stricture that provides ambulatory recovery, minimal complications and durable outcomes.

Optilume is the cost-effective alternative* to recurrent endoscopic management that breaks the cycle of recurring urethral strictures.

*Data on file

Simple

Easily achieve relief

In the ROBUST 1 and ROBUST 3 trials with patients who had received multiple prior dilations, there were:

No device-related serious complications* 

No impact on erectile function

*Elliott SP, et al. The Optilume Drug Coated Balloon for recurrent anterior urethral strictures: 3-year results for the ROBUST I study. 36th Annual EAU Congress; P0392; 2021

Elliott SP, et al. Interim Results for the ROBUST III Trial Evaluating the Optilume Drug Coated Balloon for Anterior Urethral Strictures. 36th Annual EAU Congress; 2021

Safe

Proven on a very difficult
patient population 

Durable

The breakthrough treatment to break the cycle

Optilume delivers sustained relief due to paclitaxel’s ability to limit fibrosis that leads to recurrence.* 

*Elliott SP, et al. The Optilume Drug Coated Balloon for recurrent anterior urethral strictures: 3-year results for the ROBUST I study. 36th Annual EAU Congress; P0392; 2021

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This changes everything

Optilume, the drug-coated balloon for immediate relief and durable results

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Indications for use, warnings and other important safety information can be found in the product labeling supplied with each device.