PRODUCT
Self-Expandable Valve (SEV) Radial Force Test
Simulation of the radial force in self-expandable valves
Standard Test
Based on the ISO 5840-3 standard on cardiovascular implants – Heart valve substitutes implanted by transcatheter techniques
Report for Regulatory Submission
Creation of a result report following the FDA guidelines for regulatory submissions
Easy to Use
Well-designed wizard that guides through the setup of the computation step by step
Self-Expandable Valve Radial Force Test is based on a computational finite element model which describes the compression and expansion of a self-expandible heart valve prosthesis, following ISO 5840-3 standard. The test aims to characterize Radial Resistive Force and Chronic Outward Force in self-expandible heart valves. The product also provides maps of mechanical strain within the valve geometry.
Self-Expandable Valve Radial Force Test enables simulations of Radial resistive force and Chronic outward force test in various types of self-expandable heart valves made in Nitinol, such assuch as transcatheter aortic and mitral valves. The tool can be used to test different prototype designs before manufacturing, or to test the final device design for regulatory submission, as a report following FDA guidelines is provided to the user.
Self-Expandable Valve Radial Force Test enables to:
- Securely test a proprietary valve design
- Simulate radial compression and expansion in various types of self-expandable heart valves, in order to characterize Radial Resistive Force and Chronic Outward Force
- Inspect strain values within the valve geometry
- Customize material parameters or use literature parameters
- Generate a report for regulatory submission based on FDA guidelines
Research team
Self-Expandable Valve Radial Force Test is the result of a collaboration between Politecnico di Torino and InSilicoTrials Technologies