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atrial endocardial electrode lead of j
Telectronics
Summary: The atrial endocardial electrode lead of J by Telectronics is a device used for cardiac pacing. It is primarily used in patients requiring atrial sensing and pacing. Key evidence highlights its role in improving myocardial contractility and optimizing cardiac resynchronization therapy.
FDA Clearance Information
Pathway
510K
Number
K811593 ↗
Decision Date
October 13, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The atrial endocardial electrode lead of J was cleared by the FDA via the 510(k) pathway on October 13, 1981. Manufactured by Telectronics, it is classified as a Class III device.
What It Is
The atrial endocardial electrode lead of J is a cardiac pacing device designed to sense and pace the atrium. It is intended for use in patients with cardiac arrhythmias requiring atrial pacing to maintain atrioventricular synchrony.
Clinical Applications
This device is commonly used in clinical scenarios involving atrial fibrillation, first-degree atrioventricular block, and cardiac resynchronization therapy. It is particularly useful in optimizing pacing intervals and improving cardiac contractility.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. The studies span from 2015 to 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report improvements in myocardial contractility and atrioventricular synchrony in patients with prolonged PQ intervals. The device has shown efficacy in optimizing cardiac resynchronization therapy by adjusting pacing intervals based on haemodynamic feedback.
Safety Profile
Reported complications include the risk of stroke or transient ischemic attack associated with implanted leads, particularly in patients with patent foramen ovale. No other significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of long-term follow-up data. Further research is needed to explore the device's performance in diverse patient populations and its long-term safety profile.
Frequently Asked Questions
What are the clinical indications for atrial endocardial electrode lead of J?
The device is indicated for patients requiring atrial pacing to maintain atrioventricular synchrony, particularly in cases of atrial fibrillation and first-degree AV block.
What outcomes have been reported in clinical studies?
Studies have reported improvements in myocardial contractility and optimization of cardiac resynchronization therapy through pacing interval adjustments.
What complications have been reported?
Safety data indicate a risk of stroke or transient ischemic attack, especially in patients with patent foramen ovale.
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.