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.

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.

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How durable are the outcomes?

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).

• Simple | Easily achieve relief
• Safe | Proven on a difficult patient population
• 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.

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