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electrode temporary myocardial
Winn Hirsch & Assoc.
Summary: The electrode temporary myocardial by Winn Hirsch & Assoc. is a device used for temporary cardiac pacing. It is primarily used in cases of transient bradycardia. Key evidence highlights its role in managing complications associated with temporary pacing.
FDA Clearance Information
Pathway
510K
Number
K760513 ↗
Decision Date
October 15, 1976
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The electrode temporary myocardial was cleared through the FDA 510k pathway on October 15, 1976. It is manufactured by Winn Hirsch & Assoc. and classified as a Class 3 device.
What It Is
The electrode temporary myocardial is a device designed for temporary cardiac pacing. It is used to manage transient bradycardia by delivering electrical impulses to the heart. This device is intended for short-term use in clinical settings.
Clinical Applications
Commonly used in post-operative settings or during acute cardiac events where temporary pacing is required. It is particularly useful in managing bradycardia until a permanent solution can be implemented.
Evidence Summary
The literature includes 14 studies, comprising retrospective analyses and reviews, published between 2014 and 2025. These studies explore the device's efficacy and safety in various clinical scenarios.
Reported Outcomes
Published studies report that the electrode temporary myocardial is effective in managing transient bradycardia. It provides a temporary solution in critical care settings, particularly during myocardial infarction and other acute cardiac events.
Safety Profile
Reported complications include risks of infections, myocardial lacerations, and device displacement. These adverse events highlight the need for careful monitoring during use.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and optimize device use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for electrode temporary myocardial?
The device is indicated for temporary cardiac pacing in cases of transient bradycardia, particularly in post-operative and acute cardiac care settings.
What outcomes have been reported in clinical studies?
Studies report effective management of transient bradycardia and temporary pacing during myocardial infarction and other acute cardiac events.
What complications have been reported?
Safety data indicate risks of infections, myocardial lacerations, and device displacement during use.
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.