Coating Durability with Particle Analysis
To ensure stents or stent grafts do not pose an embolic risk over the lifetime of the implant, we perform simultaneous pulsatile durability and coating durability testing. In-line particle sensors provide a time-course of particle data throughout test duration. Membrane filters are utilized to collect any particulates generated. Shed particles are sized, counted, and then captured for subsequent analysis via SEM/EDX and/or FTIR, providing an assessment of integrity and efficacy of coated implants.
In collaboration with Dynatek, patented coating durability testers allow for the aforementioned simultaneous testing of both pulsatile durability and coating durability. A wide range of stent sizes can be accommodated, ranging from 2mm-12mm ID. Similarly, a wide range of particle sizes can be counted, sized, and captured, ranging from 7μm to 1,000μm.
The simultaneous pulsatile durability and coating durability testing is often critical towards successful regulatory submissions. In addition, for newer biodegradable stent designs which are designed to degrade over the life of the implant, capturing and understanding the degradation products is essential.
Testing complies to the following family of 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
For additional details on particulate evaluations, please see our Acute Particulate Evaluation page.
For more information on testing and evaluation of your vascular devices, please feel free to contact us.