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temporary transvenous pacmker electrode
Stanco Medical
Summary: The temporary transvenous pacemaker electrode by Stanco Medical is used for temporary cardiac pacing in emergency settings. Key evidence highlights its role in managing severe dysrhythmias and training applications.
FDA Clearance Information
Pathway
510K
Number
K792131 ↗
Decision Date
November 13, 1979
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 13, 1979. It is manufactured by Stanco Medical and classified as a Class 2 medical device.
What It Is
The temporary transvenous pacemaker electrode is a device used to provide temporary cardiac pacing. It is inserted transvenously and is crucial in managing acute cardiac dysrhythmias, particularly in emergency settings.
Clinical Applications
This device is commonly used in emergency medicine for patients experiencing severe bradyarrhythmias or other life-threatening dysrhythmias. It is also utilized in training scenarios for resident cardiologists.
Evidence Summary
The literature includes 8 studies ranging from 1992 to 2024, encompassing various study types such as RCTs, prospective, and retrospective studies. These studies focus on the device's application in emergency settings and training.
Reported Outcomes
Published studies report that the temporary transvenous pacemaker electrode is effective in managing severe dysrhythmias, with successful pacing outcomes in emergency scenarios. It is also noted for its utility in training simulations for cardiologists.
Safety Profile
Reported complications include hypotension during activation and challenges in catheter placement. However, the use of intracavitary electrocardiogram guidance has been suggested to mitigate some placement issues.
Evidence Limitations
The evidence is limited by the variability in training and procedural techniques across studies. Further research is needed to standardize training protocols and evaluate long-term outcomes.
Frequently Asked Questions
What are the clinical indications for temporary transvenous pacemaker electrode?
The device is indicated for temporary cardiac pacing in patients with severe bradyarrhythmias or life-threatening dysrhythmias.
What outcomes have been reported in clinical studies?
Studies report effective management of severe dysrhythmias and successful pacing outcomes, particularly in emergency settings.
What complications have been reported?
Reported complications include hypotension during activation and challenges with catheter placement.
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.