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medtronic models 4057 4557 endocardial pacing lead
Medtronic Vascular
Summary: The Medtronic Models 4057 and 4557 are endocardial pacing leads used for cardiac pacing. Key evidence highlights their role in managing arrhythmias with a focus on safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K882452 ↗
Decision Date
August 25, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Models 4057 and 4557 endocardial pacing leads were cleared by the FDA via the 510(k) pathway on August 25, 1988. Manufactured by Medtronic Vascular, they are classified as Class III devices.
What It Is
The Medtronic Models 4057 and 4557 are endocardial pacing leads designed for cardiac pacing. They are used to deliver electrical impulses to the heart to maintain an adequate heart rate, particularly in patients with arrhythmias.
Clinical Applications
These pacing leads are commonly used in patients requiring cardiac pacing due to arrhythmias such as bradycardia. They are implanted in the heart's endocardial surface to ensure effective pacing and rhythm management.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, case reports, and retrospective analyses. The studies span from 2023 to 2025, providing insights into the device's clinical performance.
Reported Outcomes
Published studies report that the Medtronic pacing leads effectively manage arrhythmias, with improvements in patient outcomes such as reduced arrhythmia episodes. The device's role in guiding catheter ablation and its impact on ventricular tachycardia treatment have been highlighted.
Safety Profile
Reported complications include issues related to lead placement and potential for arrhythmia exacerbation. However, the studies emphasize the overall safety of the device when used as intended.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for more long-term data. Further research is needed to explore the device's performance in diverse patient populations and its long-term efficacy.
Frequently Asked Questions
What are the clinical indications for Medtronic Models 4057 4557 endocardial pacing lead?
The device is indicated for patients requiring cardiac pacing due to arrhythmias such as bradycardia.
What outcomes have been reported in clinical studies?
Studies report effective arrhythmia management and improved patient outcomes, including reduced arrhythmia episodes.
What complications have been reported?
Safety data indicate potential complications related to lead placement and arrhythmia exacerbation, though overall safety is emphasized.
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.