Analysis and Computational Modeling

ViVitro Labs provides a large array of computational modeling tools, such as Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), Fluid-Structure Interaction (FSI) that can be used to assess the impact of anatomical and physiological boundary conditions on the design of a medical devices. 

The correlation between computational modeling and in-vitro studies is strong: in-vitro experiments can be used to validate or provide input to CFD models, FEA can be used to predict failure modes to apply proper cyclic loads during accelerate fatigue studies.

Computational modeling tools can determine the worst-case stresses and strains on stent-like structures for various physiological loading conditions or identify design characteristics that could lead to thrombogenic and haemolytic events during a transcatheter valve deployment.  Computational Modeling can significantly reduce test validation time and cost, and at the same time optimize test sample utilization.

Test Procedure

Structural analysis – FEA

  • Advanced structural analysis capabilities
  • ANSYS Structural software, using Finite Element Method
  • ANSYS Explicit dynamics for drop testing and impact assessments
  • Advanced linear and nonlinear modeling

Computational fluid dynamics – CFD

  • Thermal, fluid dynamics modeling,
  • Multiphase, multi-physics modeling
  • ANSYS – Fluent, CFX
  • Finite volume method

Fluid-Structure Interaction – FSI

  • One way coupling and two-way coupling (implicit iterative).
  • Internal coupling within ANSYS Workbench
  • Requires proper planning to identify most efficient modeling strategy.

ViVitro Labs’ computational modeling studies include

  • 3D Models numerical models
  • Sensitivity analysis
  • Verification of model
  • Parametric studies as appropriate

Measured Parameters

Maximum stress and strain for various loading conditions.

Flow field velocity assessment, shear rates, wall shear stresses, and estimation of the washout time/recirculation/separation, stagnation and turbulent.

Scope

  • Balloon expandable stent: CrCo, SS, Biores
  • Self-expanding stent: NiTi, SS
  • Coronary stent
  • Peripheral stent: Carotid, renal, ilio-femoral
  • Stent-Graft: AAA, TAA, PE covered, PTFE covered, tissue covered
  • TAVI stent structure
  • TMVR stent structure
  • Vena Cava filters
  • Occluders- LAA closure, PFO closure
  • Oesophageal Stent
  • Any stent like structure

Service Levels

Applicable Standards

  • ISO 25539-2:2020
    Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

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

  • FDA-1545
    FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff

Related Tests

Structural Analysis (Using FEA)

Structural Analysis (Using FEA)

Fluid and Thermal Analysis (using FVM)

Fluid and Thermal Analysis (using FVM)

Fluid and Structure Interaction (coupled FEA and FVM)

Fluid and Structure Interaction (coupled FEA and FVM)


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:

Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Accredited by A2LA and Cofrac.

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

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