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permanent implantable jp endocardial leads w tip
Biotronik, Gmbh &
Summary: Permanent implantable JP endocardial leads are used in cardiac pacing and defibrillation, primarily by cardiologists. They are crucial for managing arrhythmias and heart failure.
FDA Clearance Information
Pathway
510K
Number
K910609 ↗
Decision Date
August 28, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 28, 1991, by Biotronik, Gmbh &. It is classified as a Class III medical device.
What It Is
Permanent implantable JP endocardial leads are components of cardiac pacing systems. They are inserted into the heart's endocardial surface to deliver electrical impulses, helping to maintain a regular heart rhythm. These leads are essential in pacemaker and implantable cardioverter-defibrillator (ICD) systems, providing reliable cardiac stimulation and monitoring.
Clinical Applications
These leads are commonly used in the management of arrhythmias, such as atrial fibrillation and ventricular tachycardia, and in patients with heart failure requiring cardiac resynchronization therapy. They are typically used in cardiology settings, including hospitals and specialized cardiac centers, and are implanted by electrophysiologists and cardiothoracic surgeons.
Indications for Use
The device is indicated for patients with arrhythmias requiring pacing or defibrillation. It is suitable for individuals with conditions like bradycardia, heart block, or those at risk of sudden cardiac arrest.
Practical Considerations
These leads come in various lengths and configurations to accommodate different patient anatomies and clinical needs. Compatibility with specific pacemaker or ICD systems should be verified. Proper implantation technique is crucial to ensure optimal performance and minimize complications.
Related Literature
The linked study explored the use of a permanent epicardial left ventricular pacing lead in identifying the origin of ventricular tachycardia (VT) in a patient with previous cardiac surgery. The study found that pacing maneuvers from the lead could help identify epicardial VT circuits, leading to successful surgical cryoablation. However, the study's findings are limited by its focus on a single patient case, and broader applicability requires further research.
Frequently Asked Questions
What is permanent implantable JP endocardial leads used for?
They are used for cardiac pacing and defibrillation to manage arrhythmias and heart failure.
What specialties typically use this device?
Cardiologists, electrophysiologists, and cardiothoracic surgeons typically use these leads.
What are the FDA-cleared indications?
The leads are indicated for patients with arrhythmias needing pacing or defibrillation, such as those with bradycardia or at risk of sudden cardiac arrest.
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.