Pacemaker leads are insulated wires that deliver electrical pulses as needed to bring the heart back to a normal rhythm. Our cardiovascular device testing experts understand how crucial it is that these devices perform as intended to keep patients safe and improve their quality of life.
Pacemaker leads and advances in cardiac pacing are part of the foundation for the development of neurostimulator leads and neuromodulation therapies. Stimulator lead designs play a critical role in the emergence of these therapies and require extensive testing.
Pacemaker and defibrillator lead testing
Pacemaker lead testing allows manufacturers to understand how their device design meets industry standards and guidelines. Our experts evaluate pacemaker leads to collect data that assures the device is safe and effective before being introduced to the market.
Electrical and mechanical tests are conducted on components, subassemblies, or finished leads, as applicable. We perform pacemaker lead testing in an environment simulating in vivo conditions.
Our pacemaker lead testing 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
- 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
For more information about our neurostimulator or pacemaker lead testing services, contact us today.
British Standards Institution
- BS EN 45502-2-2
International Electrotechnical Commission
- IEC 60601-1, IEC 60601-2-10, IEC 62353
International Organization for Standardization
- ISO 5841-3, ISO 14708-1, ISO 14708-2, ISO 14708-3
The FDA Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions outlines many of the recommended tests for cardiac leads.
Neurostimulator Lead Testing
Neurostimulator lead testing subjects devices to flex fatigue and distal tip buckling, representing a minimum of 10 years post-implantation service life. Learn more from our experts.
Stent & Graft Testing
Element’s cardiovascular device experts offer a comprehensive suite of stent and graft testing including pulsatile durability, fatigue, visual inspection, and custom test methods.
Coating and Particulate Testing
Minimizing particulates and increasing coating lubricity can be two competing requirements, which presents challenges for device manufacturers. Our experts evaluate coatings and particulates intending to bring safe and reliable products to market.
Preconditioning Stents for Fatigue through Simulated Use Testing
Simulated use testing of implantable cardiovascular medical devices is a well-established non-clinical engineering test used to serve many purposes including delivery, deployment and retraction of a stent.