STENT-DESIGN (LASERCUT)

Unsere Stärken

• Stent Konzeption 
• Stent Konstruktion (2D and 3D) 
• Stent nummerisch validieren und qualifizieren mit Hilfe Finite Elemente Simulation
• Fertigungszeichnungen bereitstellen (Lasercut-drawing)

STENTVALIDIERUNG UND OPTIMIERUNG

Folgende Parameter können optimiert werden: 

• Radialkraft 
• Flexibilität im Gefäß
• Distale und Proximale Stent-Seite
• Crimpverhalten 
• Expansionsverhalten 
• Fatigue (Lebensdauer)

Folgende Internationalen Normen und Regelwerke werden in diesem Rahmen verwendet:

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 FEA (BRAIDED UND LASERCUT)

Wir übernehmen den nummerischen Nachweis Ihres Stents und führen folgende Simulationen durch: 

• Radialkraft (im intended used Bereich des Stents) 
• Crimpen (radial comprimieren bis Katheter ID)

 Wärmebehandelte Materialparameter verwenden (zB: NiTinol wärmebehandelt) !!!

Expandieren (bis zum gewünschten Durchmesser)

• Stent Fatigue ( Stent-Dauerfestigkeit im menschlischen Gefäß) 
• Stent deployment (Freisetzung)
• Stent foreshortening (Stent axial komprimieren)
• Virtual Stenting (Stentimplantation)

Folgende Internationalen Normen und Regelwerke werden in diesem Rahmen verwendet: 

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