Stent Securement Testing
The SR1000 stent securement testing equipment measures and records the force required to dislodge a balloon-expandable stent from its position on a balloon. The mechanical device in the stent retention tester is a dual-sectioned, segmental head. One section radially grips the balloon while the second captures the stent edge. These head sections separate to dislodge the stent proximally or distally from the balloon. Stepper motor linear actuators ensure precise diameter control and smooth pull action. Test results can be used for regulatory submissions, competitive product testing, R & D device evaluation, and inline manufacturing quality assurance.
The SR1000 stent securement test equipment is proven to produce the most repeatable test results compared with alternative tape and shim methods. The system is self-aligning so that operator variability will not impact test results. Customer’s have found utilizing the SR1000 side by side with MSI’s stent crimping equipment allows R&D engineers to quickly optimize crimper processing settings. The test data coming from the SR1000 gives direct feedback how adjustments to the crimping parameters impact stent securement results.
MSI’s SR1000 equipment can help validate your device to the following international recommendations:
- S. Food and Drug Administration. (2010.) Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. Center for Devices and Radiological Health, Silver Spring, MD, USA.
- ASTM F2394-07 (2013). Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System. ASTM International, West Conshocken, PA.
- ISO (2008). ISO 25539-2 Cardiovascular implants – Endovascular devices – Part 2: Vascular Stents. International Organization for Standardization, Geneva, Switzerland.