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endocardial carbon-tip lead
Pacesetter Systems
Summary: The endocardial carbon-tip lead is a cardiac device used in pacemaker systems to ensure proper heart rhythm management. It is primarily used by cardiologists in patients requiring DDD pacing.
FDA Clearance Information
Pathway
510K
Number
K861481 ↗
Decision Date
June 6, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on June 6, 1986. It is manufactured by Pacesetter Systems and classified as a Class 3 device.
What It Is
The endocardial carbon-tip lead is a component of pacemaker systems, designed to be placed within the heart's chambers to deliver electrical impulses. It features a carbon tip that enhances conductivity and minimizes tissue reaction. This device is crucial for maintaining appropriate heart rhythms in patients with arrhythmias, particularly those requiring dual-chamber pacing.
Clinical Applications
This lead is commonly used in cardiology, particularly in settings where patients require dual-chamber pacing (DDD mode). It is suitable for patients with atrioventricular block or sick sinus syndrome. The device is typically implanted in hospital settings by electrophysiologists or cardiologists specializing in device implantation.
Indications for Use
The FDA indications suggest this device is for patients who need assistance in maintaining proper heart rhythm, particularly those with conditions like atrioventricular block. It is used in conjunction with pacemakers to ensure effective cardiac pacing.
Practical Considerations
The endocardial carbon-tip lead is compatible with most DDD pacemaker systems. Clinicians should consider the lead's length and compatibility with the patient's anatomy during implantation. Proper programming of the pacemaker is essential to avoid issues like far-field sensing.
Related Literature
The linked study investigated the prevalence and clinical significance of far-field QRS complex sensing via atrial pacemaker leads in 119 patients with DDD pacemakers. It found that 35% of patients experienced this phenomenon, which could be mitigated by adjusting atrial amplifier sensitivity or other programming changes. The study highlighted the importance of intraoperative prediction and adjustment to maintain effective pacing without reoperation. Limitations include its retrospective nature and focus on a specific electrode type.
Frequently Asked Questions
What is the endocardial carbon-tip lead used for?
It is used in pacemaker systems to help maintain proper heart rhythms in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists who specialize in cardiac device implantation and management.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring assistance in maintaining heart rhythm, particularly those with atrioventricular block or similar conditions.
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.