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cardiac electrode
Meadox Medicals, Div. Boston Scientific
Summary: The cardiac electrode by Meadox Medicals is used in cardiac arrhythmia management. Key evidence highlights novel electrode configurations improving therapy efficacy.
FDA Clearance Information
Pathway
510K
Number
K760443 ↗
Decision Date
August 26, 1976
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The cardiac electrode was cleared by the FDA via the 510k pathway on August 26, 1976. Manufactured by Meadox Medicals, a division of Boston Scientific, it is classified as a Class 3 device.
What It Is
The cardiac electrode is a medical device used to deliver electrical impulses to the heart for arrhythmia management. It is typically part of an implanted cardioverter defibrillator (ICD) system.
Clinical Applications
Commonly used in patients with ventricular tachycardia or other arrhythmias, the cardiac electrode helps in pacing and defibrillation to restore normal heart rhythm.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and retrospective analyses, conducted between 2019 and 2022.
Reported Outcomes
Published studies report that novel electrode configurations, such as 'bipolar' and 'transmural', may enhance the efficacy of anti-tachycardia pacing therapy. Intra-subject classification accuracy for stress detection using ECG signals was reported at 93.3%.
Safety Profile
Reported complications include the potential for pain and tissue damage from strong defibrillation shocks. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies. Further research is needed to validate novel electrode configurations and their clinical benefits.
Frequently Asked Questions
What are the clinical indications for cardiac electrode?
The cardiac electrode is indicated for use in patients requiring management of cardiac arrhythmias, particularly ventricular tachycardia.
What outcomes have been reported in clinical studies?
Studies have reported improved efficacy with novel electrode configurations and high accuracy in stress detection using ECG signals.
What complications have been reported?
Safety data indicate potential pain and tissue damage from defibrillation shocks, though specific adverse events were not detailed.
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.