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


ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

ISO 17025 Accredited
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Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.

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