We are a world leader in medical device testing, equipment, services and consulting. Core products & services centered around stent testing, heart valve testing, acute particulate stent testing, particulates shed from catheters guide wires, implantable device delivery systems, fatigue to fracture stent testing, and coated durability device testing. Over 35 years of experience.
Arab Health 2019 Dubai Success
Acute medical particulate testing
Dynatek’s new Fatigue-to-Fracture Tester highlighted in a paper presented at a recent ASTM International Symposium.
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 Froscher of Cortronik 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 on Fourth Symposium and Fatigue of Metallic Medical Materials and Devices to be available at the ASTM STP in the near future.
Dynatek’s products are designed to fulfill current and anticipated international regulations. Learn more about how our machines satisfy the following standards:
ASTM F2394 – 07(2017)
- ASTM WK60510
- ASTM WK60511
Dynatek’s innovations list continues to grow
- First to develop fatigue to fracture testing of stents.
- First to develop technology for integrated, real-time acute particulate testing.
- First commercially available coating durability tester with in-line particulate analysis.
- First to develop precise high-speed photographic verification protocols and procedures.
- First to offer a commercially available pulsatile artificial heart tester.
- First to use 5% to 7% compliance for mock vessels.
- First in the use of precise, optically clear mock vessels.
- First to use tuned fluid oscillation in heart valve testing.
- First to create velocity flow standard.
- First to introduce Dynamic Internal Compliance of mock vessels.
- First commercially available stent/graft durability tester with single ended pressurization. Read more