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apc implantable pacing leads
American Pacemaker
Summary: The APC Implantable Pacing Leads are used in cardiac pacing systems to deliver electrical impulses to the heart. They are primarily used by cardiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K812807 ↗
Decision Date
January 18, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The APC Implantable Pacing Leads were cleared via the FDA 510(k) pathway on January 18, 1982. Manufactured by American Pacemaker, this Class III device is used in cardiac pacing systems.
What It Is
The APC Implantable Pacing Leads are components of cardiac pacing systems, designed to transmit electrical impulses from a pacemaker to the heart muscle. These leads are crucial for maintaining proper heart rhythm in patients with arrhythmias. They are typically inserted transvenously and positioned within the heart chambers to ensure effective pacing.
Clinical Applications
These pacing leads are commonly used in the management of bradycardia, where the heart beats too slowly. Cardiologists often use them in hospital settings, particularly in cardiac catheterization labs, to implant pacemakers in patients with conditions like heart block or sick sinus syndrome. The device is suitable for adult and elderly patient populations requiring long-term cardiac rhythm management.
Indications for Use
The APC Implantable Pacing Leads are indicated for patients who require electrical pacing of the heart due to conditions such as bradycardia or heart block. They are used to ensure the heart maintains an adequate rate and rhythm.
Practical Considerations
The leads come in various lengths to accommodate different patient anatomies and are compatible with most pacemaker generators. Proper placement and secure fixation of the leads are crucial for optimal performance and longevity of the pacing system.
Related Literature
The linked study, titled 'InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry,' appears to focus on the registry of specific pacing models. While the abstract is not available, such studies typically evaluate the performance, safety, and patient outcomes associated with the devices. Limitations may include lack of detailed results or specific patient demographics.
Frequently Asked Questions
What is APC Implantable Pacing Leads used for?
They are used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in cardiac rhythm management.
What are the FDA-cleared indications?
The leads are indicated for patients needing electrical pacing due to conditions like bradycardia 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.