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Cardifix Endocardial Pacing Lead
Intermedics
Summary: The Cardifix Endocardial Pacing Lead by Intermedics is a device used for cardiac pacing. It is primarily used in patients requiring endocardial pacing. Key evidence highlights its use in pediatric patients and variations in pacing outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K922042 ↗
Decision Date ?
April 29, 1993
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Cardifix Endocardial Pacing Lead was cleared via the FDA 510(k) pathway on April 29, 1993. It is manufactured by Intermedics and classified as a Class III medical device.
What It Is
The Cardifix Endocardial Pacing Lead is a medical device designed for endocardial pacing, which involves placing the lead inside the heart chamber. It is intended for use in patients with conditions such as atrioventricular block or sinus node dysfunction.
FDA-Cleared Indications
- Endocardial cardiac pacing when permanent pacing is clinically indicated.
- Use as part of a pacemaker system for patients with an indication for cardiac rhythm support.
- Pacing applications involving the cardiac chambers reached by a transvenous endocardial lead.
Clinical Applications
- Transvenous endocardial pacing in patients who require permanent cardiac pacing.
- Pacing support for selected patients with atrioventricular conduction block.
- Pacing support for selected patients with sinus node dysfunction.
- Use in appropriately selected adult or pediatric patients when the lead and pacemaker system are compatible.
Evidence Summary
The available literature includes systematic reviews and meta-analyses, with studies conducted up to 2023. The evidence base comprises various study types, including RCTs and retrospective analyses, focusing on endocardial pacing outcomes.
Reported Outcomes
Published studies report that endocardial pacing with the Cardifix lead is effective in managing atrioventricular block and sinus node dysfunction. Outcomes such as optimal hemodynamic atrioventricular delay and lead-related complications have been explored, with variations noted based on lead positioning.
Safety Profile
Reported complications include lead-related issues such as hemothorax and venous occlusion. The incidence of these complications varies, with some studies highlighting differences between epicardial and endocardial approaches.
Evidence Limitations
Current evidence is limited by the variability in study designs and patient populations. Further research is needed to establish long-term outcomes and to compare the efficacy of endocardial versus epicardial pacing in diverse clinical settings.
Practical Considerations
- The lead is placed through a venous access site and advanced under fluoroscopic imaging into a cardiac chamber; the exact chamber and fixation method depend on the lead design and pacing plan.
- Compatibility with the pulse generator, connectors, programmed pacing mode, and other implanted components must be confirmed before implantation.
- Lead dimensions, available lengths, fixation features, and electrical specifications should be verified in the original device labeling and implanting physician documentation.
- MRI safety cannot be assumed for this older lead. MRI eligibility depends on the complete implanted system and specific labeling; confirm with the manufacturer and the patient's device specialist before MRI.
- Potential complications include infection, bleeding, venous thrombosis, lead dislodgement, perforation, abnormal heart rhythms, failure to capture, and later lead malfunction. Contraindications and precautions depend on the patient's anatomy, infection status, venous access, and pacing needs.
Frequently Asked Questions
What are the clinical indications for Cardifix Endocardial Pacing Lead?
The Cardifix Endocardial Pacing Lead is indicated for patients requiring cardiac pacing, particularly those with atrioventricular block or sinus node dysfunction.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective management of atrioventricular block and sinus node dysfunction, with variations in optimal pacing outcomes based on lead positioning.
What complications have been reported?
Safety data from evidence indicate complications such as hemothorax and venous occlusion, with varying incidence based on the pacing approach.
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.