Landmark procedures launch the ENDURE 1 clinical study evaluating Optilume’s safety and feasibility as a new minimally invasive option for patients with benign ureteric strictures.
PORTSMOUTH, N.H., October 28, 2025 – Laborie Medical Technologies, a global leader in diagnostic and therapeutic devices, today announced the successful completion of the first procedures using the Optilume® Ureteric Drug-Coated Balloon (DCB) in the ENDURE 1 study. These groundbreaking procedures mark a major milestone in advancing treatment options for patients suffering from benign ureteric strictures.
The initial procedures were performed by Jaime Landman, MD, at University of California Irvine Health along with other participating investigators, as part of the ENDURE 1 clinical trial (NCT07020520). This prospective, multi-center trial is designed to assess the safety and feasibility of Optilume in treating benign ureteric strictures up to 4 centimeters in length. The Optilume DCB combines mechanical dilation with localized delivery of paclitaxel, an established antiproliferative drug, to help prevent scar tissue recurrence and is designed to help maintain long-term ureteral patency.
Ureteric strictures are a narrowing of the ureter caused by scar tissue, and can result from kidney stones, surgery, radiotherapy, or trauma. This condition often leads to pain, infection, and kidney damage. Current treatments, such as repeat dilations and stenting, frequently result in recurrence, and severe cases may require reconstructive surgery. Optilume offers a minimally invasive option that may improve patient outcomes and reduce the need for repeat procedures.
“We are proud to achieve this important milestone for Optilume in the ureters,” said Chris Smith, CEO of Laborie. “This innovation builds on the proven clinical success of Optilume in anterior urethral strictures and represents a significant step toward expanding treatment options for patients with limited choices.”
The ENDURE 1 study will enroll up to 60 patients across multiple U.S. sites, with follow-up extending over five years. Key study endpoints include technical success, freedom from retreatment, improvements in kidney function, and patient-reported outcomes.
“Patients with ureteric strictures have limited durable solutions and face significant challenges, including the risk of severe kidney damage.” said Dr. Landman. “Optilume’s novel combination of dilation and drug delivery has the potential to transform how we treat this notoriously difficult condition.”
The Optilume Ureteric Drug Coated Balloon is an investigational device limited by federal (United States) law to investigational use and is not available for commercial use.
About Laborie Medical Technologies
Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on Urology, Urogynecology, Gastroenterology, Obstetrics, Gynecology & Neonatal Health. We manufacture and deliver high-quality, high-impact diagnostic and therapeutic products that help clinicians and hospitals preserve and restore patient dignity. Clinicians and hospitals look to us as the market-leading experts in our business segments, and we support our products with a world-class clinical education & information program. Laborie is a portfolio company of Patricia Industries. For more information visit www.laborie.com.
