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ventricular pacing leads models 865 867
Pacesetter Systems
Summary: The ventricular pacing leads models 865 and 867 are used for cardiac pacing in patients requiring ventricular support. They are typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K831435 ↗
Decision Date
June 8, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The ventricular pacing leads models 865 and 867 received FDA clearance through the 510(k) pathway on June 8, 1983. Manufactured by Pacesetter Systems, these devices are classified as Class III.
What It Is
Ventricular pacing leads are medical devices used to deliver electrical impulses to the heart's ventricles, helping to maintain an adequate heart rate in patients with bradycardia or heart block. They are implanted transvenously and connected to a pacemaker, which regulates the heart's rhythm. These leads are crucial for patients who require long-term cardiac pacing support.
Clinical Applications
These pacing leads are commonly used in cardiology and electrophysiology to manage arrhythmias, particularly in patients with heart block or bradycardia. They are typically implanted in hospital settings during a procedure that involves threading the lead through a vein into the heart. The patient population includes those with symptomatic bradycardia or atrioventricular block.
Indications for Use
The FDA indications for these ventricular pacing leads include use in patients who require electrical stimulation of the heart's ventricles due to conditions like heart block or bradycardia. They are intended for patients who need assistance in maintaining a regular heart rhythm.
Practical Considerations
When considering these leads, clinicians should be aware of the typical sizes and compatibility with various pacemaker models. Proper placement technique is crucial to ensure effective pacing and minimize complications. Regular follow-up is necessary to monitor lead function and patient response.
Related Literature
The linked study investigated high defibrillation thresholds (DFTs) in patients with implantable cardioverter defibrillators (ICDs) using transvenous leads. It found that patients with high DFTs had lower left ventricular ejection fractions and worse NYHA functional class. The study highlights the importance of identifying patients at risk for high DFTs, although it is limited by its focus on a specific patient population and device type.
Frequently Asked Questions
What is the ventricular pacing leads models 865 867 used for?
These leads are used for cardiac pacing in patients with heart block or bradycardia to maintain an adequate heart rate.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in hospital settings.
What are the FDA-cleared indications?
These leads are indicated for use in patients requiring ventricular pacing due to conditions like heart block or bradycardia.
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.