Laborie Begins ENDURE 1 Study with Optilume for Ureteric Strictures

Laborie Advances Treatment Options for Ureteric Strictures with New Study

Laborie Medical Technologies, known for its innovative medical devices, has recently achieved a vital milestone with the initiation of the ENDURE 1 study. This clinical trial focuses on evaluating the safety and efficacy of the Optilume® Ureteric Drug-Coated Balloon (DCB) in treating patients with benign ureteric strictures, a condition known to cause significant complications, including pain and kidney damage.

What Are Ureteric Strictures?

Ureteric strictures refer to the narrowing of the ureter, which can occur due to various factors such as scar tissue following surgery, radiotherapy, or injuries, as well as repercussions from kidney stones. Current treatment protocols often involve repeat dilation or stenting, which can lead to recurring issues and may even necessitate surgical reconstruction in more severe cases. Therefore, a more effective and less invasive treatment option has long been sought.

The Breakthrough in Treatment

The groundbreaking procedures utilizing the Optilume DCB were conducted by renowned urologist Dr. Jaime Landman at the University of California Irvine Health. This study, listed as NCT07020520, is a prospective, multi-center trial aiming to assess how effectively the Optilume can treat ureteric strictures that are up to four centimeters long. The Optilume DCB functions by combining mechanical dilation with a localized delivery of paclitaxel, a well-established antiproliferative agent that aids in preventing scar tissue from reforming, thus improving the long-term success of the procedure.

Chris Smith, CEO of Laborie, expressed pride in this achievement, acknowledging that it represents a significant advancement in treatment options available for patients who often have limited choices. He emphasized how this innovation extends the proven success of Optilume’s application in managing anterior urethral strictures and marked expansion in therapeutic approaches.

Dr. Landman reiterated the need for better solutions for patients suffering from ureteric strictures, highlighting the risks associated with inadequate treatment and potential kidney damage. Optilume’s cutting-edge combination of balloon dilation and drug delivery could potentially revolutionize management strategies for this complex and frequently troublesome condition.

What’s Next in the ENDURE 1 Study?

The ENDURE 1 study plans to recruit up to 60 patients at various locations across the United States and includes five years of follow-up assessments. Key metrics that will be evaluated during this period include technical success rates, freedom from the need for re-treatment, improvements in kidney function, and patient-reported outcomes.

Laborie emphasizes the importance of rigorous clinical trials to substantiate the efficacy and safety of new medical technologies. The company ensures its commitment to developing products that align with the needs of healthcare providers and improve patient care.

Conclusion

With the beginning of the ENDURE 1 study, Laborie Medical Technologies is poised to provide new hope for patients suffering from ureteric strictures. The Optilume DCB represents a promising, minimally invasive option that could redefine the standard of care and significantly enhance the quality of life for affected individuals. As the trial progresses, the medical community eagerly anticipates the potential outcomes that may lead to a necessary evolution in treatment protocols.