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laserdish poly unipolar ventri lead w trail tines
Telectronics Pacing Systems
Summary: The Laserdish Poly Unipolar Ventri Lead is a cardiac pacing lead used in conjunction with pacemakers to manage arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K904741 ↗
Decision Date
January 8, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Laserdish Poly Unipolar Ventri Lead was cleared through the FDA 510(k) pathway on January 8, 1991. Manufactured by Telectronics Pacing Systems, it is classified as a Class III device.
What It Is
The Laserdish Poly Unipolar Ventri Lead is a specialized cardiac lead designed for use with pacemakers. It features a unipolar design, which means it has a single electrode that interfaces with the heart tissue to deliver electrical impulses. The 'trail tines' help secure the lead in place within the heart, ensuring consistent contact and function. This device is crucial for patients requiring cardiac pacing due to arrhythmias or heart block.
Clinical Applications
This device is commonly used in cardiac electrophysiology procedures, particularly in the implantation of pacemakers. Cardiologists and electrophysiologists use it in hospital settings, often in catheterization labs or surgical suites. It is suitable for patients with conditions such as bradycardia or atrioventricular block, where reliable cardiac pacing is necessary.
Indications for Use
The Laserdish Poly Unipolar Ventri Lead is indicated for patients who require cardiac pacing due to conditions like slow heart rates or heart block. It is used to maintain adequate heart rhythm and cardiac output.
Practical Considerations
The lead is typically available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker systems that support unipolar leads. Proper technique during implantation is crucial to ensure secure placement and function.
Frequently Asked Questions
What is the Laserdish Poly Unipolar Ventri Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac 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.