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pacing electrode
Pacesetter Systems
Summary: The pacing electrode by Pacesetter Systems is used for cardiac pacing, primarily in treating atrioventricular block. Key evidence highlights its effectiveness in maintaining ventricular synchrony.
FDA Clearance Information
Pathway
510K
Number
K834431 ↗
Decision Date
March 12, 1984
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacing electrode by Pacesetter Systems was cleared via the FDA 510k pathway on March 12, 1984. It is a Class 3 device, indicating a high level of regulatory control.
What It Is
The pacing electrode is a medical device designed to deliver electrical impulses to the heart muscle, facilitating cardiac pacing. It is primarily used in patients with conduction disorders such as atrioventricular block.
Clinical Applications
Commonly used in scenarios requiring cardiac pacing, such as complete atrioventricular block, the device helps maintain heart rhythm and prevent complications associated with bradycardia.
Evidence Summary
The literature includes 15 studies, with a mix of RCTs, prospective, and retrospective studies, published between 2021 and 2023. These studies explore various aspects of pacing electrode use and outcomes.
Reported Outcomes
Published studies report that pacing electrodes are effective in maintaining ventricular synchrony and improving cardiac function in patients with conduction disorders. His bundle pacing has shown to be a viable alternative to traditional right ventricular pacing, with benefits in preserving physiologic ventricular synchrony.
Safety Profile
Reported complications include issues related to electrode positioning and potential for lead dislodgement. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence base is limited by a lack of large-scale RCTs and long-term follow-up data. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for pacing electrode?
The pacing electrode is indicated for use in patients with conduction disorders such as complete atrioventricular block, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of ventricular synchrony and improved cardiac function, particularly with His bundle pacing.
What complications have been reported?
Reported complications include issues with electrode positioning and potential lead dislodgement, though specific safety data is limited.
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.