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Unipolar-E Endocardial Tined Lead
Cook Pacemaker
Summary: The unipolar-e endocardial tined lead by Cook Pacemaker is a cardiac pacing lead cleared by the FDA in 1983. It is primarily used in pacemaker implantation. Key evidence highlights its role in stroke risk due to thrombus formation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K832245 ↗
Decision Date ?
August 12, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The unipolar-e endocardial tined lead was cleared by the FDA via the 510(k) pathway on August 12, 1983. It is manufactured by Cook Pacemaker and classified as a Class III device.
What It Is
The unipolar-e endocardial tined lead is a cardiac pacing lead designed for implantation in the heart's endocardial surface. It features tines for secure attachment and is used in conjunction with pacemakers to manage arrhythmias.
FDA-Cleared Indications
- Use as an endocardial cardiac pacing lead in patients who require permanent pacemaker therapy.
- Use for delivery of pacing impulses to the heart when treatment of a slow or abnormal heart rhythm is indicated.
Clinical Applications
- Permanent pacemaker implantation with an endocardial lead.
- Ventricular pacing for patients with clinically indicated bradyarrhythmias.
- Use in patients who require cardiac pacing, including appropriately selected adults and children.
- Endocardial lead placement with connection to a compatible pacemaker pulse generator.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to retrospective analyses, published between 1992 and 2015. These studies explore lead characteristics, outcomes, and safety in various clinical settings.
Reported Outcomes
Published studies report that the unipolar-e endocardial tined lead is associated with increased risk of thrombus formation, potentially leading to stroke or transient ischemic attack. Outcomes in pediatric populations with ventricular pacemakers show variable performance, with some evidence of increased lead failure in high-impedance models.
Safety Profile
Reported complications include thrombus formation and potential for paradoxical embolism due to right-to-left shunting. Lead extraction studies indicate higher tensile forces required for tined leads compared to screw-in types, with no significant myocardial damage observed.
Evidence Limitations
The evidence is limited by small sample sizes and lack of long-term follow-up in some studies. Further research is needed to fully understand the long-term safety and efficacy of this device, particularly in diverse patient populations.
Practical Considerations
- The lead is a unipolar, tined design intended to remain positioned within the heart after implantation; the tines require careful handling during placement and removal.
- Compatibility with the pacemaker pulse generator, connector configuration, electrical characteristics, and available lead dimensions must be confirmed before implantation.
- The record is from 1983 and does not establish modern MRI-conditional labeling; MRI safety should not be assumed and requires review of the complete device system and current manufacturer or FDA information.
- Potential contraindications and precautions include active infection, unsuitable venous or cardiac anatomy, inability to obtain stable lead position, and patient-specific bleeding or procedural risks.
- Lead performance can change over time because of insulation damage, conductor fracture, dislodgment, elevated pacing thresholds, or thrombus formation; device follow-up is required.
Frequently Asked Questions
What are the clinical indications for unipolar-e endocardial tined lead?
The device is indicated for use in patients requiring ventricular pacing, particularly those with bradyarrhythmias.
What outcomes have been reported in clinical studies?
Studies report increased risk of thrombus formation and potential stroke, with variable performance in pediatric populations.
What complications have been reported?
Safety data indicate risks of thrombus formation, paradoxical embolism, and challenges in lead extraction due to higher tensile forces.
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.