📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an endocardial lead in a pacemaker system for patients who require cardiac pacing.
- Use in patients requiring dual-chamber pacing, including DDD pacing, when clinically indicated.
- Use to deliver pacing impulses to the heart in patients with rhythm disorders such as atrioventricular block or sick sinus syndrome, according to the applicable pacemaker system labeling.
Clinical Applications
- Endocardial lead placement as part of implantation of a dual-chamber pacemaker system.
- Right-heart chamber pacing for patients with clinically indicated bradyarrhythmia.
- Pacing support for selected patients with atrioventricular block.
- Pacing support for selected patients with sick sinus syndrome.
- Connection to a compatible pacemaker pulse generator for sensing and delivery of electrical impulses.
Practical Considerations
- Confirm connector type, lead dimensions, and electrical compatibility with the selected pacemaker pulse generator before implantation.
- Choose a lead length appropriate for the patient's anatomy and the intended cardiac chamber; excessive slack or tension can impair performance.
- Implantation is performed under fluoroscopic imaging, commonly through venous access, with local anesthesia and sedation or another anesthesia plan selected by the implanting team.
- Pacemaker programming should be checked after implantation to confirm sensing, capture, and appropriate chamber timing, including evaluation for far-field sensing.
- MRI eligibility cannot be assumed from the carbon-tip design or the lead alone. MRI safety depends on the complete lead-and-generator system and the applicable labeling; the 1986 FDA record does not establish MRI-conditional status.
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.