📊 Evidence-Based Reference
Additional Cardiac Pacing Leads 1020 Through 1035
Pacesetter Systems
Summary: Additional cardiac pacing leads 1020-1035 by Pacesetter Systems are used in cardiac resynchronization therapy. Key evidence includes studies on lead longevity and pacemaker upgrades.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K870824 ↗
Decision Date ?
March 20, 1987
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The additional cardiac pacing leads 1020-1035 were cleared by the FDA through the 510(k) pathway on March 20, 1987. Manufactured by Pacesetter Systems, these leads are classified as Class 3 devices.
What It Is
The additional cardiac pacing leads 1020-1035 are designed for use in cardiac resynchronization therapy, providing electrical impulses to the heart to improve synchronization of cardiac contractions. They are intended for patients with heart failure and electrical dyssynchrony.
FDA-Cleared Indications
- Use as additional cardiac pacing leads with a compatible cardiac pacemaker system.
- Use in systems intended to provide cardiac resynchronization through ventricular pacing.
- Use when an existing pacemaker system requires an additional pacing lead, when permitted by the device labeling.
Clinical Applications
- Placement as part of a cardiac resynchronization therapy system for appropriately selected patients with heart failure and electrical conduction delay.
- Addition to an existing pacemaker system during an upgrade when an additional ventricular pacing lead is indicated.
- Delivery of electrical pacing impulses from an implanted pulse generator to cardiac tissue.
Evidence Summary
The literature includes four studies ranging from 1975 to 2025, encompassing randomized controlled trials, prospective, and retrospective studies. These studies explore lead longevity, pacemaker upgrades, and electrophysiological characteristics.
Reported Outcomes
Published studies report that the use of additional cardiac pacing leads can improve outcomes in cardiac resynchronization therapy by enhancing lead longevity and facilitating upgrades in pacemaker systems. The CAPTURE trial specifically evaluated automated threshold algorithms, contributing to the understanding of lead performance.
Safety Profile
Reported complications include technical failures of transvenous leads in pediatric patients, as noted in studies on pacemaker upgrades. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of comprehensive safety data. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The record does not specify the lead lengths, diameters, connector type, fixation mechanism, or other size options; these should be confirmed in the original labeling.
- Compatibility with the pulse generator, connector, introducer, and other implanted leads must be verified before implantation.
- Implantation requires venous access and fluoroscopic or other imaging guidance, with positioning in the intended cardiac chamber according to the system instructions.
- MRI eligibility cannot be determined from this record. Do not assume the lead is MRI-conditional; evaluate the complete implanted system and current manufacturer labeling.
- Potential complications include lead dislodgement, failure to capture or sense, venous injury or thrombosis, infection, perforation, arrhythmia, and lead fracture or insulation failure.
Frequently Asked Questions
What are the clinical indications for additional cardiac pacing leads 1020-1035?
The clinical indications include use in cardiac resynchronization therapy for patients with heart failure and electrical dyssynchrony, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported improved lead longevity and successful pacemaker system upgrades, contributing to enhanced cardiac resynchronization therapy outcomes.
What complications have been reported?
Safety data from evidence indicates technical failures of transvenous leads, particularly in pediatric patients undergoing pacemaker upgrades.
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.