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endocardial electrode
Vitatron Medical
Summary: The endocardial electrode by Vitatron Medical is used for cardiac pacing. It is FDA 510k cleared and primarily used in scenarios requiring precise cardiac stimulation. Key evidence highlights its role in improving cardiac resynchronization therapy outcomes.
FDA Clearance Information
Pathway
510K
Number
K810928 ↗
Decision Date
July 2, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial electrode by Vitatron Medical was cleared through the FDA 510k pathway on July 2, 1981. It is a Class 3 device under product code DTB.
What It Is
The endocardial electrode is a device used for cardiac pacing, designed to deliver electrical impulses to the heart muscle. It is intended for use in patients requiring cardiac resynchronization therapy or other pacing needs.
Clinical Applications
Commonly used in patients with heart failure requiring cardiac resynchronization therapy, the endocardial electrode is also applicable in scenarios where precise pacing is necessary to manage arrhythmias.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, published between 1996 and 2023. These studies explore the electrode's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that guided implantation of endocardial electrodes can improve acute hemodynamic response and chronic cardiac remodeling. Evidence suggests that optimal site selection enhances contractility and resynchronization outcomes. Additionally, the electrode's stability is maintained when properly fixed during implantation.
Safety Profile
Reported complications include microdislocation of the electrode, which can affect pacing efficacy. Studies also note the potential for displacement when not adequately secured, particularly when fixed to certain anatomical structures.
Evidence Limitations
Current evidence is limited by the variability in study designs and small sample sizes in some analyses. Further research is needed to standardize implantation techniques and evaluate long-term outcomes across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for endocardial electrode?
The endocardial electrode is indicated for use in cardiac pacing, particularly in patients requiring cardiac resynchronization therapy.
What outcomes have been reported in clinical studies?
Studies report improved hemodynamic response and cardiac remodeling with guided implantation of the electrode.
What complications have been reported?
Complications include electrode microdislocation and potential displacement if not properly secured.
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.