đź“Š Evidence-Based Reference
models 6917t 6917at 4951m epicardial pace leads
Medtronic Vascular
Summary: The Medtronic epicardial pace leads are used for cardiac pacing. Cleared by FDA via 510k in 1992, they are primarily used in cardiac surgery. Key evidence includes studies on cardiac perfusion and epicardial applications.
FDA Clearance Information
Pathway
510K
Number
K921124 ↗
Decision Date
May 22, 1992
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic epicardial pace leads were cleared by the FDA through the 510k pathway on May 22, 1992. Manufactured by Medtronic Vascular, these devices are classified as Class III medical devices.
What It Is
The Medtronic epicardial pace leads are designed for cardiac pacing, particularly in patients undergoing cardiac surgery. They are intended to provide temporary pacing support by attaching directly to the heart's epicardial surface.
Clinical Applications
These leads are commonly used in scenarios requiring temporary cardiac pacing, such as during and after cardiac surgery. They are particularly useful in managing arrhythmias and ensuring cardiac stability in the perioperative period.
Evidence Summary
The available literature includes 10 studies, with a mix of RCTs, prospective, and retrospective studies. The studies range from 2023 to 2025, focusing on cardiac perfusion and epicardial applications.
Reported Outcomes
Published studies report advancements in understanding cardiac perfusion and epicardial applications. The use of epicardial pace leads has been associated with improved management of cardiac arrhythmias during surgery. However, specific efficacy outcomes related to pacing effectiveness were not detailed in the provided studies.
Safety Profile
Reported complications include potential risks associated with surgical implantation and removal of the leads. However, specific adverse events related to the use of these leads were not detailed in the provided studies.
Evidence Limitations
The evidence lacks specific data on long-term outcomes and direct comparisons with other pacing methods. Further research is needed to explore the full range of clinical applications and long-term safety of these devices.
Frequently Asked Questions
What are the clinical indications for epicardial pace leads?
Epicardial pace leads are indicated for temporary cardiac pacing during and after cardiac surgery, particularly in managing arrhythmias.
What outcomes have been reported in clinical studies?
Studies have reported improved management of cardiac arrhythmias during surgery, but specific efficacy outcomes were not detailed.
What complications have been reported?
Reported complications include risks associated with surgical implantation and removal, though specific adverse events were not detailed.
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.