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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
510K
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.
Clinical Applications
This device is commonly used in scenarios where patients require cardiac pacing, particularly in cases of atrioventricular block or sinus node dysfunction. It is applicable in both adult and pediatric populations.
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.
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.