Performance Testing of Generic Heart Valve Frames Manufactured From Different Material Qualities (Gen I - III)

Medical device performance testing is one of the trend-setting elements for overall device success. Within this study we evaluate - from an OEM perspective - relevant performance criteria for a generic Nitinol heart-valve-frame. Performance testing will include mechanical and microstructural investigation, F2129 corrosion testing as well as functional testing.

The principally used specimen will be an electropolished generic heart-valve-frame, which is manufactured from three different material qualities: Generation I (SE508), Generation II (ELI) and Generation III (HCF) as well as specific test specimens for additional evaluation such as rings, discs, halftubes and dogbones. All data will be collected throughout the following test: Tensile test, hydrogen content testing, DSC testing, dimensional testing, microstructural analysis, radial force and permanent set testing.

In addition visual inspection in a serial production manner as well as SEM inspection will be performed to determine further differences of the different tube qualities.

This comprehensive study will examine the performance differences of a generic Nitinol heart-valve-frame manufactured from different materials and therefore also correlate the material related dependency.