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models 4012 4512 transvenous tined-
Medtronic Vascular
Summary: The Models 4012 and 4512 are transvenous tined leads used in cardiac pacing, manufactured by Medtronic Vascular. They are primarily used by cardiologists for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K842032 ↗
Decision Date
January 18, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on January 18, 1985. Manufactured by Medtronic Vascular, it is classified as a Class III device under product code DTB.
What It Is
The Models 4012 and 4512 are transvenous tined leads designed for use in cardiac pacemaker systems. These leads are inserted through the veins and positioned in the heart to deliver electrical impulses that regulate heartbeats. The tined design helps secure the lead in place within the heart tissue, ensuring stable and effective pacing.
Clinical Applications
These leads are commonly used in the implantation of pacemakers, particularly in patients with bradycardia or other conditions that cause slow heart rhythms. Cardiologists and electrophysiologists typically perform these procedures in hospital settings. The device is suitable for a wide range of patients, including those with heart block or sick sinus syndrome.
Indications for Use
The FDA indications suggest that these leads are intended for patients who require pacing support due to conditions like bradycardia. They are used in conjunction with a pacemaker to ensure proper heart rhythm management.
Practical Considerations
The leads are available in various lengths to accommodate different patient anatomies. Compatibility with specific pacemaker models should be verified prior to implantation. Proper technique in securing the tines is crucial for optimal performance.
Related Literature
The linked study investigated the use of a drug-eluting collar on ventricular leads to reduce pacing thresholds. It found that leads with the collar had significantly lower thresholds both initially and chronically compared to control leads. The study highlights the potential benefits of incorporating drug-eluting technology in pacing leads, though it was limited by a small sample size.
Frequently Asked Questions
What is Models 4012 4512 Transvenous Tined used for?
These leads are used in cardiac pacing to regulate heart rhythms in patients with conditions like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads during pacemaker implantation procedures.
What are the FDA-cleared indications?
These leads are indicated for patients requiring pacing support due to conditions like 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.