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model 4951m myocardial unipolar lead
Metronic
Summary: The model 4951m myocardial unipolar lead by Metronic is a cardiac device used for myocardial pacing. Key evidence highlights its role in managing cardiac arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K031210 ↗
Decision Date
May 16, 2003
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 4951m myocardial unipolar lead was cleared by the FDA via the 510(k) pathway on May 16, 2003. It is manufactured by Metronic and classified as a Class III device.
What It Is
The model 4951m myocardial unipolar lead is designed for myocardial pacing, providing electrical stimulation to the heart muscle. It is used in patients requiring cardiac rhythm management.
Clinical Applications
This device is commonly used in scenarios involving cardiac arrhythmias, where myocardial pacing is necessary to maintain adequate heart function. It is particularly relevant in managing bradycardia.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2014 and 2023. These studies explore the device's efficacy and safety.
Reported Outcomes
Published studies report that the model 4951m myocardial unipolar lead effectively manages cardiac arrhythmias, particularly in maintaining heart rhythm during myocardial ischemia and after coronary interventions. The device has shown reliability in pacing and has been evaluated in different cardiac conditions.
Safety Profile
Reported complications include challenges in lead placement and potential arrhythmic events. However, the studies indicate that the device is generally safe when used appropriately.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale, long-term studies. Further research is needed to explore the device's efficacy in diverse patient populations and its long-term safety profile.
Frequently Asked Questions
What are the clinical indications for model 4951m myocardial unipolar lead?
The device is indicated for use in patients requiring myocardial pacing, particularly in cases of cardiac arrhythmias and bradycardia.
What outcomes have been reported in clinical studies?
Studies have reported effective management of cardiac arrhythmias and reliable pacing during myocardial ischemia and post-coronary interventions.
What complications have been reported?
Safety data indicate potential complications such as lead placement challenges and arrhythmic events, though the device is generally considered safe.
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.