Occluder & Closure Device Testing

Element tests braided metal-based support frames and their integrated polymer and fabric mesh components. Our specialized evaluation focuses on critical areas like the device "waist" that connects the two disks, as this bears most loading during use. During deployment, the device is pushed out of the catheter so it opens fully with one disc on each side of the defect. Within approximately 6 months, tissue grows over the implant and it becomes part of the heart. We assess both structural integrity and deployment mechanisms through comprehensive testing protocols.

Elements testing suite encompasses both low and high cycle fatigue assessment to validate deployment, retrieval, and long-term durability. We conduct pulsatile fatigue testing from 40 million to 600 million cycles, complemented by axial fatigue testing in tension and bending modes. Specialized protocols evaluate fretting wear and corrosion in braided designs.

• Low cycle and high cycle fatigue testing for occluder devices
• Occluder device accelerated durability testing

We develop custom test protocols tailored to your specific device design and regulatory needs. Our approach combines simulated use geometry setups for deployment testing with long-term durability assessment. Regular inspection intervals throughout testing provide comprehensive performance data, with detailed documentation supporting your regulatory submissions. Device failure is defined by the manufacturer's criteria, and we inspect devices before, during, and after testing at predetermined intervals.

Low cycle and high cycle fatigue testing for occluder devices:

This testing involves repeated deployment and retrieval of the device to simulate initial misplacement and re-deployment (low cycle). It also evaluates the device’s ability to withstand long-term physiological stresses during implantation (high cycle). Testing is particularly focused on the "waist" of the device, which experiences the most load during use. Devices made with braided metal frames and polymer or fabric mesh are assessed for fretting wear and corrosion.

Occluder device accelerated durability testing:

Using ElectroForce 9100, 3200, or 3300 test instruments, we conduct pulsatile fatigue testing for 40 million to 600 million cycles. Feasibility tests target 40 million cycles, while regulatory tests run for 400 million or 600 million cycles. Axial fatigue testing is done in tension or bending. Device failure is evaluated according to the manufacturer's criteria, and devices are inspected before, during, and after testing at predefined intervals.

Our facility utilizes advanced ElectroForce 9100 stent series instruments for pulsatile fatigue testing, capable of running tests up to 600 million cycles. We employ ElectroForce 3200 and 3300 test instruments for axial fatigue testing, with specialized fixtures developed for unique device requirements.

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.

Our expertise in testing braided metal designs enables thorough evaluation of fretting wear and corrosion. We focus particularly on the critical waist section that bears the highest loading during use, with inspection protocols designed to identify potential failure modes throughout testing cycles.