EVIDENCE & QUALITY

Performance You
Can Trust.

Endura™ surface technology is supported by benchtesting, clinical observation, and rigorous qualitysystems. We believe transparent evidence is thefoundation of clinical trust.

Evidence Framework

Bench Testing

(In Vitro)

Endura™ surface performance has been evaluated through controlled laboratory testing, including friction characterization, encrustation resistance models, and surface durability assessments.

Clinical Observations

(Clinical)

Clinical use observations support that the Endura™ design contributes to a smoother placement and removal experience in routine ureteral stenting procedures.

Regulatory Compliance

(Regulatory)

Endura™ is designed and manufactured in compliance with applicable medical device standards and regulatory requirements.

Surface Performance Evidence

Hydrophilic Lubricity

Reduced Friction for Smoother Handling

Anti-Encrustation Surface Protection

In Vitro Performance Verification

Quality & Regulatory System

CatheGenix maintains a robust quality management system across the Endura™ product lifecycle - from design and development to manufacturing, distribution, and post-market surveillance.

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Quality Management

  • ISO 13485 Quality Management System
  • Product traceability system
  • Sterile single-use packaging

Testing & Evaluation

  • Biocompatibllty evaluated per ISO 10993
  • Surface performance bench tested
  • Shelf-life validation

Regulatory Status

  • FDA Cleared

FAQ

What bench tests support Endura™ surface performance?

Endura™ has undergone friction testing, encrustation resistance assays, and surface durability evaluations in controlled laboratory settings.

Is Endura™ FDA cleared?

Yes, Endura™ Ureteral Stents are FDA cleared for use in stone management and upper urinary tract drainage procedures.

What quality standards does CatheGenix follow?

CatheGenix operates under ISO 13485 and adheres to GMP and FDA standards throughout the product lifecycle.

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