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)

Fluid and Thermal Analysis (using 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. Victoria and Marseille labs accredited by A2LA.

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.