AWT Transcatheter Heart Valve Prosthesis - Open Valve
AWT Transcatheter Heart Valve Prosthesis – Open Valve

Heart Valve Fatigue Testing: Measured parameters

  • Leaflet durability – wear test
  • Leaflet kinematics – opening and closing behavior
  • Valve hydrodynamic performance inspections
  • Visual and SEM inspections

Heart Valve Fatigue Testing: Scope

  • Transcatheter valves
  • Biological valves
  • Mechanical valves
  • Venous valves
  • Valvular conduits

Heart Valve Fatigue Testing: Applicable standards

Heart Valve Fatigue Testing: Related tests

  • Hydrodynamic performance inspections
  • Device pre-conditioning – Simulated use on IDTE 2000
  • Optical Inspection
  • Scanning Electron Microscopy (SEM)
  • High speed video inspection

Heart Valve Fatigue Testing:Test method description

PROTOMED uses a swash plate drive system to conduct heart valve fatigue testing. Up to six samples can be tested in six separate chambers. As the swash plate rotates, the bellows are compressed or extended causing fluid to flow through the valves. Test fluid dispersion into separate chambers enables pressure and temperature stabilization:

  • Durability assessment of valves for 200 Millions cycles (Biological) or 400M cycles (Mechanical).
  • Test frequency 450-800 bpm, varies according to valve response.
  • Pressure transducers used to measure the transvalvular pressure difference have a natural frequency of at least 1 000 Hz and a minimum measurement accuracy of ± 0,65 kPa (± 5 mm Hg)
  • Durability shall be demonstrated based on measurement of pressure difference / regurgitant volume and by visual inspection at 5x magnification of cyclic loaded
  • Valves in water bath at 37°C
  • Worst-case pressure difference setup
  • High speed video inspection for leaflet kinematics assessment