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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 and electrophysiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K800348 ↗
Decision Date
May 28, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The unipolar lead configuration conductor was cleared via the FDA 510(k) pathway on May 28, 1980. Manufactured by Daig, it is classified as a Class 3 device under product code DTB.
What It Is
This device is a unipolar lead 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 known for their simplicity and flexibility, making them suitable for certain pacing scenarios. They are typically less bulky compared to bipolar leads, which can be advantageous in specific clinical situations.
Clinical Applications
Unipolar leads are commonly used in cardiac pacing procedures, particularly in scenarios where minimal lead size is beneficial. They are often employed in settings where lead flexibility and ease of insertion are priorities, such as in pediatric or small-framed adult patients. Cardiologists and electrophysiologists in hospitals or specialized cardiac centers typically use these devices for patients with bradycardia or other rhythm disorders.
Indications for Use
The FDA indications for this device include its use in patients requiring cardiac pacing due to arrhythmias or heart block. It is suitable for individuals who need long-term heart rhythm management.
Practical Considerations
When using unipolar leads, clinicians should consider the potential for increased susceptibility to electromagnetic interference compared to bipolar leads. Compatibility with existing pacemaker systems is crucial, and careful attention to lead placement technique is necessary to ensure optimal performance.
Related Literature
The linked study evaluated a thin bipolar pacing lead, highlighting its reduced thickness and increased flexibility compared to traditional bipolar leads. The study found that the new design achieved a body diameter and flexibility similar to unipolar leads, potentially offering the benefits of both configurations. However, the study's focus on a bipolar lead limits direct applicability to unipolar leads, and further research would be needed to confirm these findings in unipolar configurations.
Frequently Asked Questions
What is a unipolar lead configuration conductor used for?
It is used for cardiac pacing to regulate heart rhythms in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring cardiac pacing 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.