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transvenous permanent tined target tip pacing leads
Medtronic Vascular
Summary: Transvenous permanent tined target tip pacing leads are used in cardiac pacing to maintain heart rhythm. They are primarily used by cardiologists in hospitals and specialized cardiac care centers.
FDA Clearance Information
Pathway
510K
Number
K951858 ↗
Decision Date
October 12, 1995
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 12, 1995. Manufactured by Medtronic Vascular, it is classified as a Class III device.
What It Is
Transvenous permanent tined target tip pacing leads are specialized leads used in cardiac pacemakers. They are designed to be inserted through a vein and positioned in the heart to deliver electrical impulses that regulate heartbeats. The 'tined' feature helps secure the lead in place within the heart tissue, reducing the risk of dislodgement.
Clinical Applications
These pacing leads are commonly used in patients with arrhythmias such as bradycardia, where the heart beats too slowly. They are typically used in settings like cardiac catheterization labs or during surgical procedures in hospitals. Cardiologists and electrophysiologists are the primary specialists who implant these devices, often in patients with a history of heart block or sick sinus syndrome.
Indications for Use
The device is indicated for patients who require chronic cardiac pacing due to conditions like symptomatic bradycardia or heart block. It is suitable for individuals who need long-term pacing support to maintain adequate heart rhythm.
Practical Considerations
These leads come in various lengths and configurations to accommodate different patient anatomies and pacing needs. They are compatible with most modern pacemaker generators. Proper technique during insertion is crucial to ensure optimal lead placement and function.
Frequently Asked Questions
What is transvenous permanent tined target tip pacing leads used for?
They are used to deliver electrical impulses to the heart to maintain a regular heartbeat in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device, particularly in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients needing chronic cardiac pacing, such as those with symptomatic 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.