Migration Resistance – Fixation Effectiveness

Force required to displace the prosthesis within a mock artery.

Test Procedure

The endovascular prosthesis is deployed into the mock artery. Using a tensile strength machine a uniform rate of separation the endovascular prosthesis is pulled out from the mock artery and the peak force recorded.

Scope

  • Any device using vascular prostheses
  • Vascular prosthesis
  • Biological, synthetic textile/non-textile materials, non-textile material
  • Stent Grafts: SX or BX frame, NiTi, CrCo, SS, Biological tissues, synthetic textile materials/* non-textile material, non-textile material
  • Covered stent: SX or BX frame, NiTi, CrCo, SS, Biological tissue, synthetic textile/non-textile * material, non-textile material
  • Tubular, bifurcated, branched

Service Levels

Applicable Standards

  • ISO 5840-3:2021
    Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

Related Tests

OLE1101


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