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epicardial access system
Baylis Medical
Summary: The epicardial access system by Baylis Medical is designed for accessing the pericardial space during electrophysiology procedures. It is primarily used in the management of ventricular arrhythmias. Key evidence highlights its utility in improving procedural success and safety.
FDA Clearance Information
Pathway
510K
Number
K191546 ↗
Decision Date
August 2, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The epicardial access system received FDA clearance through the 510(k) pathway on August 2, 2019. It is manufactured by Baylis Medical and is classified as a Class 2 device under product code DYB.
What It Is
The epicardial access system is a medical device used to gain access to the pericardial space, primarily for electrophysiological interventions. It facilitates procedures such as ventricular arrhythmia ablation by providing a pathway to the epicardial surface of the heart.
Clinical Applications
This device is commonly used in clinical scenarios involving complex arrhythmias where epicardial mapping and ablation are required. It is also utilized in procedures for epicardial pacing and lead implantation.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2023 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the epicardial access system enhances procedural success rates in epicardial interventions. It has been shown to improve the accuracy of epicardial mapping and ablation, contributing to better management of ventricular arrhythmias.
Safety Profile
Reported complications include potential risks associated with pericardial access, such as bleeding and infection. However, studies indicate that the use of advanced imaging and mapping techniques can mitigate these risks, improving overall safety profiles.
Evidence Limitations
Current evidence is limited by the relatively small sample sizes and short follow-up periods in some studies. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for epicardial access system?
The device is indicated for use in procedures requiring access to the epicardial surface, such as ventricular arrhythmia ablation and epicardial lead implantation.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success and accuracy in epicardial mapping and ablation, leading to better management of ventricular arrhythmias.
What complications have been reported?
Safety data indicate risks such as bleeding and infection, but these are mitigated by advanced imaging and mapping techniques.
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.