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unipolar lead configuration conductor
Daig
Summary: The unipolar lead configuration conductor by Daig is a medical device used primarily in cardiac pacing. It is utilized by cardiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K770468 ↗
Decision Date
April 5, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The unipolar lead configuration conductor was cleared through the FDA 510k pathway on April 5, 1977. Manufactured by Daig, it is classified as a Class 3 device.
What It Is
This device is a unipolar lead configuration conductor used in cardiac pacing systems. It consists of a single conductor that connects the pacemaker to the heart tissue, delivering electrical impulses to regulate heartbeats. Unipolar leads are typically thinner and more flexible than their bipolar counterparts, making them easier to implant in certain anatomical scenarios.
Clinical Applications
Unipolar leads are commonly used in cardiac pacing, particularly in patients with bradycardia or other arrhythmias requiring electrical stimulation. They are often employed in settings such as hospitals and specialized cardiac care centers. Cardiologists and electrophysiologists are the primary users, and the device is suitable for both adult and pediatric populations.
Indications for Use
The device is indicated for use in patients requiring cardiac pacing to manage arrhythmias. It is particularly useful in cases where a thinner, more flexible lead is advantageous, such as in patients with smaller venous anatomy.
Practical Considerations
Unipolar leads are generally compatible with most pacemaker systems but require careful consideration of lead placement to minimize potential interference. Their thinner profile may be beneficial in patients with limited venous access.
Related Literature
The linked study evaluated a thin bipolar pacing lead, highlighting the advantages of reduced thickness and increased flexibility compared to traditional bipolar leads. The study found that the new technology allowed for a lead diameter and flexibility similar to unipolar leads. However, the study's focus was on bipolar leads, and its findings may not directly translate to unipolar lead performance.
Frequently Asked Questions
What is the unipolar lead configuration conductor used for?
It is used for cardiac pacing to manage heart rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring cardiac pacing, particularly where a thinner lead is beneficial.
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.