Optilume® Drug Coated Balloon

Laborie Medical Technologies, in collaboration with Urotronic Inc, are proud to offer an exciting and innovative, minimally invasive technology for the treatment of urethral stricture.

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

This proprietary technology combines balloon dilation and drug delivery and is well-tolerated by patients. Rapid uptake of the highly lipophilic drug, paclitaxel, limits hyperactive cell proliferation and the fibrotic scar tissue generation that results in stricture recurrence.

For additional clinical information regarding Optilume® for the treatment of urethral stricture, please click below.

CAUTION – Investigational device in the United States. Limited by federal law to investigational use.

The Optilume® procedure is similar to traditional mechanical dilation methods, making it easy to learn and perform. The semi-compliant balloon expands into the tissue, creating micro-fissures which facilitate circumferential drug absorption across the length of the strictured urethral area.

By combining a simple, effective balloon dilation with localized delivery of a proven antiproliferative drug – Optilume® aims to provide long-term relief from stricture recurrence

HOW IT WORKS

INFLATES

The atraumatic tapered tip of the Optilume® device travels easily over a guidewire to cross tight strictures. The semi-compliant inflatable balloon is inflated and expands to create micro-fissures in the urethral tissue, providing a pathway for drug absorption.

RELEASES

A novel excipient (coating) molecularly binds the drug (paclitaxel) to the balloon until the balloon inflates and dilates the urethral tissue for rapid and controlled drug release

DELIVERS

Hydrophobic and lipophilic properties support rapid cellular uptake of the drug, paclitaxel – enabling the drug to pass through the urethral wall and take up residency in the tissue

OPTILUME BENEFITS

  • Ends the high recurrence cycle of failed endoscopic stricture management
  • Is minimally invasive
  • Compatible with flexible cystoscopes for maximum patient comfort
  • Balloon dynamic compliance provides optimal expansion for urology applications
  • 73% reduction in IPSS1
  • 250% increase* in Qmax1
  • 81% freedom from repeat intervention1

* Qmax improved from baseline (5.0 ml/sec) to 24 months (17.5 ml/sec)1.

1. Mann, R. A., Virasoro, R., DeLong, J. M., Estrella, R. E., Pichardo, M., Rodríguez Lay, R., Espino, G., Roth, J. D., & Elliott, S. P. (2020). A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study. Canadian Urological Association Journal15(2), 20-5. https://doi.org/10.5489/cuaj.6661

 

  • Procedure Type: Urethral Stricture Treatment
  • Balloon Lumen: 30F (fully inflated to 10atm)
  • 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

A urethral stricture is a narrowing caused by scarring of the lining of the urethra and the surrounding corpus spongiosum. Strictures can range from less than 1cm long to those that extend the entire length of the urethra. They can occur at any point along the urethra but are most often seen in the bulbar region.

With minor strictures, there may be less signs of any symptoms. With tighter strictures, patients may experience one or more of the following:

  • Poor urinary flow and needing to strain to pass urine
  • Spraying or splitting of the urinary stream
  • Dribbling of urine after urination
  • Needing to pass urine often (urinary frequency)
  • Urinary Tract Infections (UTI’s)
  • Reduced force of ejaculation and low ejaculate volume, and
  • Pain on passing urine

A stricture can act as a “bottleneck” which prevents complete bladder emptying. This can cause the patient to retain urine in their bladder after they pass urine, which can result in bladder, prostate or kidney infections, and lead to the formation of stones. All of these conditions can cause long-term bladder damage and kidney failure.

 

Many types of treatment are available, ranging from conservative or minimally invasive procedures, right through to complex reconstructive operations. The goal of treatment is to relieve the symptoms caused by the stricture and, if possible, to reduce the risk of the stricture returning.

The type of treatment recommended by Urology healthcare professionals depends on several factors:

  • Patient preference
  • The site (region) and length of the stricture
  • The cause of the stricture
  • Any previous treatments received relating to stricture management, and
  • Patient’s general health

For more information on the types of treatment available for the treatment of urethral stricture please visit the British Association of Urological Surgeons website and view their ‘general information about urethral stricture disease leaflet’ https://www.baus.org.uk/_userfiles/pages/files/Patients/Leaflets/Urethral%20stricture%20disease.pdf

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