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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 ?
510(k)
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.
FDA-Cleared Indications
- Temporary transvenous cardiac pacing.
- Management of acute cardiac dysrhythmias requiring temporary pacing support.
Clinical Applications
- Temporary pacing for severe bradyarrhythmias.
- Temporary pacing during acute, life-threatening dysrhythmias.
- Short-term pacing support while the underlying rhythm problem is evaluated or treated.
- Temporary cardiac pacing in emergency and hospital settings.
Reported off-label uses
- Temporary pacing during selected electrophysiology or cardiac procedures when short-term rhythm support is needed.
- Use in clinical skills and cardiology training to demonstrate temporary transvenous pacing techniques.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The electrode is inserted through a venous access site and advanced under fluoroscopic or other imaging guidance into the right-sided cardiac chambers, commonly the right ventricle.
- It must be connected to a compatible external temporary pacemaker and secured carefully to reduce dislodgement, loss of capture, infection, bleeding, and vascular injury.
- Exact electrode length, diameter, tip configuration, connector type, and compatibility should be confirmed from the current device labeling because specifications may vary by model and production date.
- MRI safety cannot be assumed for the electrode, the external pacemaker, or the complete system. MRI should be avoided unless the specific implanted and connected components are documented as MR Safe or MR Conditional under the applicable conditions.
- Temporary transvenous pacing requires continuous ECG and hemodynamic monitoring. Potential contraindications and precautions include active bloodstream infection, significant coagulopathy, venous access obstruction, and inability to safely obtain vascular access.
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.