Optilume® - At Last, A Breakthrough Treatment for Strictures
A Safe, Simple and Durable Treatment for Urethral Stricture
Current endoscopic anterior urethral stricture treatments are common practice and often ineffective, leading to multiple repeat procedures with diminishing results.5
Optilume® is an effective alternative to traditional endoscopic stricture treatments, offering minimally invasive, immediate relief. Optilume® works by inhibiting new scar tissue growth that often recurs after dilations or direct visual internal urethrotomy (DVIU).
All this in a simple out-patient procedure.
What Is Optilume® and How Is It Used?
- Optilume® is a small, cylindrical balloon coated with medication engineered to simultaneously open the urethra and slow or stop stricture regrowth
- Similar balloons have successfully prevented re-treatment in cardiovascular procedures for several years1
- Recovery is mild4
- No impact on erectile function
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
How Optilume® Works
How durable are the outcomes?
- 73% of patients treated with Optilume® did not require further stricture treatment 5 years after their Optilume® procedure3
- Optilume® increased urinary flow rate (Qmax) by 298%1
- Optilume® decreased symptom severity scores for patients by 71%1
¹Data on file. DSC016-004 rJ Robust I Clinical Study Final Report
²Rosenfield K, Jaff MR, White CJ, et al. Trial of Paclitaxel-Coated Balloon for Artery Disease. NEJM 2015;372(2):145-53
³Data on file. RP1277-001 rB
4Data on File: TR1041
5Steenkamp JW, Heyns CF, de Kock MLS, Internal Urethrotomy Versus Dilation as Treatment for Male Urethral Strictures: A Prospective, Randomized Comparison. Journal of Urology, Vol. 157.96-101. January 1997
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.
*List of treatments is not all inclusive.