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Focus J81F J83F J41F J43F Pacing Leads
Ela Medical
Summary: The focus j81f j83f j41f j43f pacing leads by Ela Medical are FDA-cleared devices used in cardiac pacing. Key evidence includes 10 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K896742 ↗
Decision Date ?
July 17, 1990
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The focus j81f j83f j41f j43f pacing leads were cleared through the FDA 510(k) pathway on July 17, 1990. Manufactured by Ela Medical, these devices are classified as Class 3 under product code DTB.
What It Is
The focus j81f j83f j41f j43f pacing leads are medical devices designed for use in cardiac pacing. They are intended to deliver electrical impulses to the heart to maintain an adequate heart rate, especially in patients with arrhythmias.
FDA-Cleared Indications
- Use as part of a cardiac pacemaker system when electrical stimulation of the heart is clinically indicated.
- Use to provide pacing support in patients with an inadequate heart rate caused by disorders of cardiac impulse formation or conduction.
Clinical Applications
- Permanent pacemaker implantation for symptomatic bradycardia.
- Pacing support for atrioventricular conduction disorders, including heart block, when indicated.
- Connection of an implanted pacemaker generator to the appropriate cardiac chamber.
- Delivery of electrical pacing impulses to maintain an adequate heart rate.
Evidence Summary
The available literature includes 10 studies, though specific details on study types, total sample size, and date range are not provided. The studies are listed in PubMed but lack detailed outcomes and safety data.
Reported Outcomes
Published studies report limited information on the efficacy of the focus pacing leads. The evidence provided does not specify outcomes related to the device's performance or patient benefits.
Safety Profile
Reported complications include limited safety data from the provided evidence. Specific adverse events or complications associated with the use of these pacing leads are not detailed in the studies listed.
Evidence Limitations
The evidence lacks detailed information on study outcomes and safety, indicating a gap in comprehensive data. Further research is needed to evaluate the efficacy and safety of these pacing leads in clinical practice.
Practical Considerations
- These leads are used with a compatible pacemaker generator; connector standards, lead polarity, sensing configuration, and electrical specifications must be confirmed before implantation.
- Implantation generally requires venous access, fluoroscopic guidance, positioning in the intended cardiac chamber, and testing of sensing, capture threshold, and lead impedance.
- The available evidence does not establish that these older lead models are MRI-conditional. MRI should be performed only after confirming the complete implanted system and current manufacturer or institutional guidance.
- Potential complications include lead dislodgement, failure to capture or sense, insulation or conductor failure, infection, venous thrombosis, cardiac perforation, and arrhythmia.
- Lead removal or revision can be more complex as implant duration increases and should be evaluated by an experienced electrophysiology team.
Frequently Asked Questions
What are the clinical indications for focus j81f j83f j41f j43f pacing leads?
The clinical indications are not detailed in the provided evidence. Refer to FDA documentation for specific indications.
What outcomes have been reported in clinical studies?
The provided evidence does not specify outcomes related to the device's performance or patient benefits.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed in the provided studies.
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.