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electrode lead of silicone elastometer
Telectronics
Summary: The electrode lead of silicone elastomer by Telectronics is a medical device used in cardiac procedures. It is primarily used by cardiologists and electrophysiologists for pacing and sensing electrical activity in the heart.
FDA Clearance Information
Pathway
510K
Number
K823452 ↗
Decision Date
January 8, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on January 8, 1983. Manufactured by Telectronics, it is classified as a Class III device under product code DTB.
What It Is
The electrode lead of silicone elastomer is a flexible, insulated wire designed to connect a pacemaker or defibrillator to the heart. It transmits electrical impulses from the device to the heart muscle and senses cardiac electrical activity. The silicone elastomer provides durability and biocompatibility, essential for long-term implantation.
Clinical Applications
This device is commonly used in cardiac pacing and defibrillation procedures. It is essential in managing arrhythmias, heart block, or heart failure. Cardiologists and electrophysiologists typically use it in hospital settings, particularly in cardiac catheterization labs and operating rooms. It is suitable for adult and pediatric patients requiring cardiac rhythm management.
Indications for Use
The electrode lead is indicated for patients who require electrical pacing or sensing due to arrhythmias or heart block. It is used in conjunction with pacemakers or defibrillators to maintain appropriate heart rhythm.
Practical Considerations
The electrode lead comes in various lengths and configurations to accommodate different patient anatomies and procedural requirements. It is compatible with most pacemaker and defibrillator models. Proper technique during implantation is crucial to ensure optimal lead placement and function.
Frequently Asked Questions
What is the electrode lead of silicone elastomer used for?
It is used for transmitting electrical impulses from a pacemaker or defibrillator to the heart and sensing cardiac electrical activity.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management procedures.
What are the FDA-cleared indications?
It is indicated for patients needing electrical pacing or sensing due to arrhythmias 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.