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cardifix ez bipolar unipolar endocardial pacing lead
Intermedics
Summary: The Cardifix EZ Bipolar Unipolar Endocardial Pacing Lead is a medical device used for cardiac pacing. It is primarily used by cardiologists in settings requiring precise heart rhythm management.
FDA Clearance Information
Pathway
510K
Number
K955550 ↗
Decision Date
June 19, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cardifix EZ was cleared through the FDA 510(k) pathway on June 19, 1996. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Cardifix EZ is an endocardial pacing lead designed for use in cardiac pacing procedures. It can be used in both bipolar and unipolar configurations, allowing flexibility in pacing strategies. The lead is implanted within the heart to deliver electrical impulses that help maintain an appropriate heart rhythm, particularly in patients with arrhythmias.
Clinical Applications
This device is commonly used in the management of arrhythmias, particularly in patients who require long-term pacing support. It is typically used in cardiology departments, electrophysiology labs, and during cardiac surgeries. The device is suitable for adult patients who have conditions such as bradycardia or heart block, where consistent pacing is necessary to maintain cardiac output.
Indications for Use
The Cardifix EZ is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. It helps maintain a regular heart rhythm by delivering electrical impulses directly to the heart muscle.
Practical Considerations
The Cardifix EZ is compatible with most pacemaker generators. It is important to ensure proper lead placement and secure fixation to prevent dislodgement. Clinicians should be familiar with the pacing system's programming to optimize patient outcomes.
Related Literature
The linked study investigated the endo-epicardial mapping of the human sinus node in vivo, revealing novel electrophysiologic findings and anatomic correlations. This research enhances the understanding of the sinoatrial node's complex structure and its role in cardiac pacing. However, the study's findings are limited by its focus on a specific anatomical area and may not directly translate to broader clinical applications.
Frequently Asked Questions
What is Cardifix EZ Bipolar Unipolar Endocardial Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions such as bradycardia or heart block.
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.