Radial Fatigue Testing
To evaluate the long-term mechanical integrity of stents, stent grafts, and other endovascular devices, we perform radial pulsatile durability testing in customized mock silicone vessels, replicating in vivo conditions. Testing is carried out in accordance with recognized ISO, ASTM, and FDA guidelines to evaluate the fatigue performance and potential failure modes of your components prior to regulatory submission.
In collaboration with Dynatek, a world leader in medical device testing, our testing offering complies with the following standards (where applicable):
- ISO 25539-1:2017 – Cardiovascular Implants – Endovascular Devices – Part 1: Endovascular Prostheses
- ISO 25539-2:2012 – Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents
- Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; April 18, 2010
- ASTM F2477-07 (2013) – Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
- USP General Chapter - Particulate Matter in Injections
- AAMI TIR42:2010 – Evaluation of Particulates Associated with Vascular Medical Devices
- ISO 7198:2016 – Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
We can accommodate a wide range of stent and stent graft sizes, ranging from 2mm to 50mm ID. Similarly, we can test in a range of mock silicone vessels which are manufactured in-house at Dynatek– these can be straight, curved, or bifurcated.
With the combined experience and expertise of Lucideon and Dynatek, together we can help to guide you with testing strategy, setup, and execution. Typical discussions and decision points include:
- Should test to run-out, failure, or both?
- How should our strategy change for evaluation of bioabsorbable or polymeric stents as compared to conventional metallic stents?
- Do we need to test for stent migration?
- What parameters should we design in our protocol?
In addition to the fatigue testing, using the Materials Science expertise at Lucideon we can help to perform post-hoc analyses on the tested devices, on the testing fluid, or on generated particulate and/or foreign matter. Typical analyses aim at understanding failure modes, evaluating stents for signs of corrosion and/or degradation, analysing fluids for ion concentrations (e.g. nickel release), or characterizing particulates.
For more information on testing and evaluation of your vascular devices, please feel free to contact us.