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catheter cardiac pacing endocardial
American Technology
Summary: The catheter cardiac pacing endocardial by American Technology is a device used for cardiac pacing. It is primarily used in scenarios requiring endocardial pacing. Key evidence highlights its role in managing arrhythmias and improving cardiac performance.
FDA Clearance Information
Pathway
510K
Number
K771528 ↗
Decision Date
August 16, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on August 16, 1977. It is manufactured by American Technology and classified as a Class III device.
What It Is
The catheter cardiac pacing endocardial is designed for endocardial pacing, providing electrical stimulation to the heart muscle. It is used in clinical settings to manage arrhythmias and improve cardiac function.
Clinical Applications
This device is commonly used in patients requiring precise cardiac pacing, particularly in cases of arrhythmias or heart block. It is often employed in both pediatric and adult populations to ensure synchronized cardiac contractions.
Evidence Summary
The literature includes 15 studies, comprising case series, RCTs, and reviews, published between 2020 and 2023. These studies explore the device's efficacy in various cardiac pacing scenarios.
Reported Outcomes
Published studies report that the device effectively manages arrhythmias and enhances cardiac performance. It has been shown to improve hemodynamic parameters and reduce ventricular dyssynchrony in both pediatric and adult patients.
Safety Profile
Reported complications include potential for electromechanical dyssynchrony and challenges in implantation. However, most studies indicate successful outcomes with minimal adverse events.
Evidence Limitations
The evidence is limited by the small sample sizes and lack of long-term follow-up in many studies. Further research is needed to establish comprehensive safety profiles and long-term efficacy.
Frequently Asked Questions
What are the clinical indications for catheter cardiac pacing endocardial?
The device is indicated for use in patients requiring endocardial pacing, particularly those with arrhythmias or heart block.
What outcomes have been reported in clinical studies?
Studies report improved cardiac performance and management of arrhythmias, with enhanced hemodynamic parameters.
What complications have been reported?
Safety data indicate potential for electromechanical dyssynchrony and implantation challenges, though adverse events are minimal.
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.