đź“‹ FDA Reference
transvenous permanent tined target tip pacing leads transvenous permanent screw-in pacing leads
Medtronic Vascular
Summary: Transvenous permanent pacing leads are used in cardiac pacing procedures to maintain heart rhythm. They are typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K961679 ↗
Decision Date July 30, 1996
Product Code DTB
Device Class Class 3
Evidence 0 studies
The device was cleared through the FDA 510(k) pathway on July 30, 1996, by Medtronic Vascular. It is classified as a Class III device under product code DTB.
What It Is
Transvenous permanent pacing leads are medical devices used to deliver electrical impulses to the heart muscle, ensuring proper heart rhythm. These leads are inserted through veins and positioned in the heart, where they are either tined or screw-in to secure placement. They are critical components of pacemaker systems, which are used to treat arrhythmias.
Clinical Applications
These pacing leads are commonly used in procedures to implant pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically perform these procedures in hospital settings, often in a cardiac catheterization lab. The patient population includes those with symptomatic arrhythmias requiring long-term pacing support.
Indications for Use
The FDA indications for these leads include use in patients who require permanent pacing due to conditions like bradycardia or heart block. They are designed for long-term implantation to help maintain adequate heart rate and rhythm.
Practical Considerations
The leads come in various lengths and configurations to accommodate different patient anatomies and clinical needs. Compatibility with specific pacemaker models should be verified. Proper technique in lead placement is crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is transvenous permanent pacing leads used for?
They are used to deliver electrical impulses to the heart to maintain a regular heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in hospital settings.
What are the FDA-cleared indications?
They are indicated for use in patients requiring permanent pacing 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.