Pacemaker Lead Testing

Element tests complete pacemaker leads, individual conductors, transition zones, anchoring sleeves, and active fixation components. Our comprehensive testing covers every critical component of your device, from individual parts to fully assembled leads, helping validate performance at every level.

Our testing program includes electrical continuity verification, leakage current measurement, bond strength testing, and mechanical load assessment. We evaluate stylet insertion forces, fatigue resistance, and mechanical loading that simulates post-implantation conditions. These tests help collect the necessary data to ensure your device is safe and effective before being submitted to regulatory bodies.

• Electrical continuity testing 

• Leakage current measurement 

• Bond strength assessment 

• Mechanical load testing 

• Fatigue resistance evaluation 

• Stylet force measurement 

• Tip pressure measurement 

• Helix rotation quantification 

We simulate in vivo conditions to provide realistic performance data. Our testing methods evaluate both electrical and mechanical aspects of your device, delivering comprehensive data for regulatory submissions and design validation. This includes:

• Electrical continuity verification of each conduction path 

• Leakage current measurement during voltage application (after soaking, before drying) 

• Measurement of the strength of each bond, joint, etc. in the lead, as well as the composite lead strength 

• Measurement of the stylet insertion and removal forces 

• Fatigue resistance of the conductor(s) and lead transition zones separately 

• Mechanical loading that mimics forces that might occur after implantation on connectors intended for joining pulse generators and leads  

• Evaluation of the performance of the anchoring sleeve packaged with the lead 

• Measurement of the pressure exerted by lead tip 

• Quantification of the number of revolutions required to extend and retract the helix of active fixation leads 

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 testing aligns with FDA guidance for permanent pacemaker leads and adaptor submissions, collecting all the quantitative data needed to demonstrate safety and effectiveness to help you navigate the complex regulatory landscape while validating device performance.