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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 for ventricular arrhythmia ablation. Key evidence highlights its utility in improving procedural success and safety.
FDA Clearance Information
Pathway
510K
Number
K213582 ↗
Decision Date
June 30, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The epicardial access system received FDA clearance through the 510(k) pathway on June 30, 2022. Manufactured by Baylis Medical, it is classified as a Class 2 device.
What It Is
The epicardial access system is a medical device used to gain access to the pericardial space, primarily for electrophysiological interventions such as ventricular arrhythmia ablation. It facilitates precise and safe epicardial access, enhancing procedural outcomes.
Clinical Applications
This device is commonly used in clinical scenarios involving complex ventricular arrhythmias where epicardial mapping and ablation are necessary. It is also utilized in procedures requiring epicardial pacing or defibrillation lead implantation.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2023 and 2025. These studies explore various aspects of epicardial access techniques and their clinical applications.
Reported Outcomes
Published studies report that the epicardial access system improves procedural success rates in ventricular arrhythmia ablation. It allows for precise needle tracking and electroanatomic mapping, reducing reliance on fluoroscopy. The system has been associated with enhanced safety and efficacy in accessing the pericardial space.
Safety Profile
Reported complications include potential risks associated with pericardial access, such as bleeding and infection. However, the use of electroanatomic mapping has been shown to mitigate some of these risks by improving procedural accuracy.
Evidence Limitations
Current evidence is limited by the relatively small sample sizes and the need for further research to establish long-term outcomes. There is also a need for more comparative studies to evaluate the system against alternative access techniques.
Frequently Asked Questions
What are the clinical indications for the epicardial access system?
The epicardial access system is indicated for use in electrophysiological procedures requiring access to the pericardial space, such as ventricular arrhythmia ablation and epicardial lead implantation.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success and safety in ventricular arrhythmia ablation, with enhanced precision in epicardial access.
What complications have been reported?
Safety data from evidence indicate potential complications such as bleeding and infection, though these are mitigated by the use of electroanatomic mapping.
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.