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pacesetter sysems endocardial tri-fix lead
Pacesetter Systems
Summary: The Pacesetter Systems Endocardial Tri-Fix Lead is a cardiac pacing lead used in conjunction with pacemakers to manage arrhythmias. It is utilized by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K854220 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Pacesetter Systems Endocardial Tri-Fix Lead was cleared via the FDA 510(k) pathway on December 4, 1985. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The Pacesetter Systems Endocardial Tri-Fix Lead is an implantable cardiac lead designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It is typically inserted transvenously and positioned in the endocardial surface of the heart. The lead features a tri-fix mechanism to enhance stability and reduce the risk of dislodgement.
Clinical Applications
This device is commonly used in the management of bradycardia and other arrhythmias requiring pacing. It is primarily used in cardiology and electrophysiology settings, particularly in hospitals and specialized cardiac centers. Patients who benefit from this device often have conditions such as sick sinus syndrome or heart block.
Indications for Use
The device is indicated for patients who require cardiac pacing due to arrhythmias like bradycardia. It is suitable for individuals with conditions that disrupt normal heart rhythm, necessitating the use of a pacemaker.
Practical Considerations
The lead is typically available in various lengths to accommodate different patient anatomies. Compatibility with specific pacemaker models should be confirmed prior to implantation. Proper technique during insertion is crucial to ensure optimal lead placement and function.
Frequently Asked Questions
What is the Pacesetter Systems Endocardial Tri-Fix Lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias like bradycardia.
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.