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.*
This device is currently under clinical investigation in the United States and is limited by federal law to investigational use.
*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*
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
All this in a simple out-patient procedure
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
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
This changes everything
Optilume, the drug-coated balloon for immediate relief and durable results
Indications for use, warnings and other important safety information can be found in the product labeling supplied with each device.