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atrial endocardial electrode lead j-tip
Telectronics
Summary: The atrial endocardial electrode lead j-tip is a medical device used in cardiac pacing. It is primarily utilized by cardiologists to ensure stable atrial pacing in patients requiring pacemakers.
FDA Clearance Information
Pathway
510K
Number
K813134 ↗
Decision Date
December 10, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on December 10, 1981. Manufactured by Telectronics, it is classified as a Class 3 device, indicating a higher level of regulatory control due to potential risks.
What It Is
The atrial endocardial electrode lead j-tip is a specialized lead used in cardiac pacing systems. It features a J-shaped tip designed to facilitate stable positioning within the atrium, reducing the risk of dislodgement. This design helps in maintaining consistent electrical contact with the atrial wall, crucial for effective pacing.
Clinical Applications
This device is commonly used in cardiac electrophysiology, particularly in the implantation of pacemakers. It is suitable for patients with atrial fibrillation or other arrhythmias requiring atrial pacing. The device is typically used in hospital settings, including cardiac catheterization labs and electrophysiology suites.
Indications for Use
The device is indicated for patients who require atrial pacing due to conditions like atrial fibrillation or other atrial arrhythmias. It helps maintain regular heart rhythms by ensuring stable electrical conduction in the atrium.
Practical Considerations
The J-tip design aids in reducing lead dislodgement, a common issue in atrial lead placement. Clinicians should consider the patient's atrial anatomy when selecting lead size and placement technique. Compatibility with existing pacing systems should also be verified.
Related Literature
The linked study examined the implantation of 87 atrial leads in 85 patients, comparing different emplacement techniques. It highlighted the effectiveness of the J-tip design in maintaining stable lead positioning with a low dislodgement rate of 6%. The study noted high action voltages sensed by the leads, indicating effective pacing. However, the study's limitations include its small sample size and the use of older lead models.
Frequently Asked Questions
What is the atrial endocardial electrode lead j-tip used for?
It is used for atrial pacing in patients with arrhythmias, ensuring stable electrical conduction in the atrium.
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 patients requiring atrial pacing due to atrial arrhythmias like atrial fibrillation.
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.