The American Society for Testing and Materials (ASTM) International subcommittee on Endovascular Test Methods developed the new standard ASTM F3211 Standard Guide for Fatigue-to-Fracture (FTF) Methodology for Cardiovascular Medical Devices.
Dr. Matthias Frotscher of Cortronik GmbH presented a paper at ASTM’s Fourth Symposium on Fatigue and Fracture of Metallic Medical Materials and Devices in May 2018. This was the culmination of three years of research and instrument development by Dynatek and Cortronik. The paper “A New Approach for Fatigue-to-Fracture Testing of Coronary Stents” presented a test methodology taking the new ASTM standard into account, which can subject cardiovascular stents to hyperphysiological loading. In combination with FEA analysis, it can help to understand how stents fracture, e.g., to optimize device designs or evaluate the criticality of manufacturing process changes with regard to fatigue without the need to test to high numbers of cycles.
This testing was run on Dynatek’s patented FtF extreme conditions radial fatigue tester. The instrument utilizes Dynatek’s more than 30 years of experience designing and manufacturing medical device testing instruments. It provides extreme loading conditions to stents, so that they can be radially stressed to a much greater degree than previously possible.
This paper has been chosen for publication in STP 1616 of the Fourth Symposium and Fatigue of Metallic Medical Materials and Devices to be available at the ASTM STP in the near future.