Stents optimization and validation

Stent optimization

 IDENTIFY PROBLEMS

The following issues can cause stents to be optimized:

  • Stent does not expand properly in the vessel
  • Too little radial force
  • Stent is not flexible enough
  • Stent is difficult to push through the catheter
  • Stent breaks at implantation
  • Proximal and distal areas appear weak
  • etc..

The following international standards and regulations are used in this context:

 

ISO 25539-1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses

ISO 25539-2: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

ISO 25539-3: Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters

ASTM F2514: Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2942: Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM F3067: Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

ASTM F2079: Elastic Recoil of Balloon-Expandable Stents

ASTM F3211: Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices.

 

FDA Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. April 18, 2010

 

FDA Guidance for Industry and FDA Staff: Reporting of Computational Modeling Studies in Medical Device Submissions. September 21, 2016

 

Heart Valves:

 

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

ISO 5910: Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices


Stent validation (numerical)

The following requirements should be fulfilled:

  • Fatigue strength (at least 1 million cycles)
  • flexibility test
  • Crimp Simulatiom
  • Expansion simulation
  • Virtual stenting

The following international standards and regulations are used in this context:

 

ISO 25539-1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses

ISO 25539-2: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

ISO 25539-3: Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters

ASTM F2514: Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2942: Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM F3067: Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

ASTM F2079: Elastic Recoil of Balloon-Expandable Stents

ASTM F3211: Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices.

 

FDA Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. April 18, 2010

 

FDA Guidance for Industry and FDA Staff: Reporting of Computational Modeling Studies in Medical Device Submissions. September 21, 2016

 

Heart Valves:

 

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

ISO 5910: Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices