Endura™ surface performance has been evaluated through controlled laboratory testing, including friction characterization, encrustation resistance models, and surface durability assessments.
Clinical use observations support that the Endura™ design contributes to a smoother placement and removal experience in routine ureteral stenting procedures.
Endura™ is designed and manufactured in compliance with applicable medical device standards and regulatory requirements.
Reduced Friction for Smoother Handling
In Vitro Performance Verification
CatheGenix maintains a robust quality management system across the Endura™ product lifecycle - from design and development to manufacturing, distribution, and post-market surveillance.
Request Quality DocumentationEndura™ has undergone friction testing, encrustation resistance assays, and surface durability evaluations in controlled laboratory settings.
Yes, Endura™ Ureteral Stents are FDA cleared for use in stone management and upper urinary tract drainage procedures.
CatheGenix operates under ISO 13485 and adheres to GMP and FDA standards throughout the product lifecycle.