Stent Fatigue Tester

 

Stent Fatigue Tester

 

 

 

 

 

 

Stent Fatigue Tester: Technical Features

  • Customizable stent fatigue tester built to client specifications – sample size and test sample dimensions
  • Direct stent strain measurement: Direct ultrasonic (US) dynamic displacement measurement
  • Direct stent oscillation frequency measurement: Direct ultrasonic (US) oscillation frequency measurement
  • Thin tube tester – Does not require deriving any specific tube compliance relationship 
  • Transparent tubes for struts and diameter integrity visualization
  • Stent Failure mode – Strut fracture, stent crush (BX only)
  • Cyclic system pressure difference monitoring
  • N° of Cycles monitoring
  • Test frequency monitoring – Stent frequency and tube pressure monitoring
  • Provided with full IQOQPQ plan and documents

Tested devices

  • Accelerate Stent Fatigue Testing - Coronary and peripheral stent
  • Accelerate Stent Fatigue Testing - Aortic, Thoracic and Heart Valves Stent
  • Accelerate Stent Fatigue Testing - Stent-Graft
  • Accelerate Stent Fatigue Testing - CrCo, SS, NiTi, Bioresorbable, Bioabsorbable, Covered, Coated stent

FDA GLP guidelines

Tested devices: Associated tests in relation to stent fatigue testing

  • Device pre-conditioning - Simulated use on IDTE 2000
  • Optical Inspection
  • Scanning Electron Microscopy (SEM)

Test method description

Stent Fatigue Tester - Not tube compliant dependent - Customizable stent fatigue tester - Built to fit client specifications.

Stent are positioned in transparent silicon tubes with thin walls. Tubes are filled with relevant test solutions depending on stent type and test requirements. A cyclic or a static differential pressure can be directly applied on the silicone tubes. The differential pressure generates a uniform periodic stress of physiologic magnitude at frequencies of up to 100 Hz. Typical tester operating mode can generate operating stress levels with peripheral pressure difference. Standard tests are performed with distilled water and under thermo regulated 37+2 °c conditions if required. Other test fluid such as saline solution can be used for biological tissue covered and biodegradable stent designs. Stent dynamic displacement and frequency is directly measured in-line by ultrasound (us) system in compliance with standard requirement and in order to ensure that dynamic amplitude levels are meeting specifications limits. Applied pressure difference, test frequency, number of cycles and stent positions within the mock artery models are monitored daily. A visual inspection is also performed daily to detect visible stent failure. Dynamic stent diameters and displacement are measured directly on the device at periodical intervals and at both the beginning and the end of the test. In order to detect early onset of failure and fracture, periodical diameter and displacement monitoring and measurement can be performed to assess stent behavior. Stent preparation, cycle counting, test frequency measurements, calibration of the pressure transducers are performed in compliance with and controlled by proper operating procedures.