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cardiac pacing electrode
Medi-Dyne Instruments
Summary: The cardiac pacing electrode by Medi-Dyne Instruments is a device used for cardiac pacing. It was FDA cleared via the 510k pathway. Key evidence highlights its stability and potential complications.
FDA Clearance Information
Pathway
510K
Number
K792379 ↗
Decision Date
December 5, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The cardiac pacing electrode was cleared by the FDA through the 510k pathway on December 5, 1979. It is manufactured by Medi-Dyne Instruments and classified as a Class 3 device.
What It Is
The cardiac pacing electrode is designed to provide electrical stimulation to the heart to maintain an adequate heart rate. It is used in patients with arrhythmias or heart block to ensure proper cardiac function.
Clinical Applications
Commonly used in scenarios such as bradycardia or heart block, the cardiac pacing electrode is crucial in maintaining heart rhythm. It is often employed in both temporary and permanent pacing situations.
Evidence Summary
The available literature includes 9 studies, with a mix of retrospective, prospective, and other study types. The studies span from 1976 to recent years, providing insights into device performance and safety.
Reported Outcomes
Published studies report that the cardiac pacing electrode is generally effective in maintaining cardiac rhythm. A method for estimating electrode stability has been described, highlighting its reliability in clinical use.
Safety Profile
Reported complications include rare occurrences of electrode fracture and pacing failure. One study noted an unusual fracture of the electrode, emphasizing the need for careful monitoring.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent large-scale trials. Further research is needed to explore long-term outcomes and newer electrode designs.
Frequently Asked Questions
What are the clinical indications for cardiac pacing electrode?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias or heart block.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and methods for assessing electrode stability.
What complications have been reported?
Safety data indicate rare instances of electrode fracture and pacing failure.
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.