📊 Evidence-Based Reference
Pacing Leads Model Ul-811 and Ul-813
Pacesetter Systems
Summary: The pacing leads model UL-811 and UL-813 by Pacesetter Systems are FDA-cleared devices used in cardiac pacing. Key evidence highlights their role in maintaining electrical synchrony and assessing lead integrity.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781776 ↗
Decision Date ?
October 27, 1978
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The pacing leads model UL-811 and UL-813 were cleared by the FDA through the 510(k) pathway on October 27, 1978. Manufactured by Pacesetter Systems, they are classified as Class III devices.
What It Is
The pacing leads model UL-811 and UL-813 are designed for cardiac pacing, facilitating electrical conduction to maintain heart rhythm. They are used in conjunction with pacemakers to ensure effective cardiac function.
FDA-Cleared Indications
- Use as a component of a cardiac pacemaker system for delivering pacing impulses to the heart.
- Use in patients who require permanent cardiac pacing for disorders of cardiac rhythm or conduction.
Clinical Applications
- Connecting an implanted pacemaker generator to cardiac tissue for therapeutic electrical stimulation.
- Supporting permanent pacing in patients with clinically significant bradycardia or impaired cardiac conduction.
- Providing an implanted electrical pathway for cardiac rhythm management when used with a compatible pacemaker system.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2015 and 2024. These studies explore aspects like torque transfer, lead placement, and impedance measurement.
Reported Outcomes
Published studies report that the pacing leads are effective in maintaining left ventricular electrical synchrony and have a low and stable capture threshold. They also highlight the importance of impedance measurement in diagnosing lead malfunctions.
Safety Profile
Reported complications include lead entanglement and impedance variations that may indicate lead malfunction. These issues underscore the need for careful monitoring and assessment during and after implantation.
Evidence Limitations
Current evidence is limited by the lack of large-scale, long-term studies. Further research is needed to establish comprehensive safety profiles and optimize deployment techniques.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and implanted according to the manufacturer's labeling.
- Implantation generally requires venous access, fluoroscopic or other imaging guidance, lead positioning in the heart, and testing of sensing and pacing thresholds.
- Lead integrity should be assessed when there is loss of capture, abnormal impedance, changes in sensing, or suspected fracture or insulation damage.
- MRI compatibility should not be assumed; these older lead models should be considered non-MRI-conditional unless current manufacturer and device records specifically document otherwise.
- Potential complications include infection, bleeding, venous injury or thrombosis, cardiac perforation, arrhythmia, lead dislodgement, and lead malfunction.
Frequently Asked Questions
What are the clinical indications for pacing leads model UL-811 and UL-813?
The clinical indications include use in cardiac resynchronization therapy and conduction system pacing, particularly in patients with heart block and arrhythmias.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of electrical synchrony and stable capture thresholds, with impedance measurement aiding in diagnosing lead issues.
What complications have been reported?
Safety data indicate complications such as lead entanglement and impedance variations, which may signal lead malfunction.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.