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epiaccess system
Epiep
Summary: The EpiAccess System by Epiep is a device designed for epicardial access, primarily used in complex arrhythmia treatments. Key evidence highlights its innovative pressure-sensing needle tip for safer procedures.
FDA Clearance Information
Pathway
510K
Number
K142245 ↗
Decision Date
October 29, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The EpiAccess System was cleared by the FDA via the 510(k) pathway on October 29, 2014. It is manufactured by Epiep and classified as a Class 2 device under product code DYB.
What It Is
The EpiAccess System is a medical device used to facilitate epicardial access during procedures such as epicardial ablation. It features a needle with an embedded pressure sensor that provides real-time pressure waveform monitoring, enhancing procedural safety.
Clinical Applications
The device is commonly used in scenarios requiring epicardial access, such as the treatment of complex arrhythmias that are refractory to endocardial ablation. It is particularly useful in reducing the risk of complications associated with conventional needle access.
Evidence Summary
The literature includes three studies: one published in 2018 and two registered clinical trials. These studies encompass various methodologies, including a multicenter human experience study, providing insights into the device's clinical application.
Reported Outcomes
Published studies report that the EpiAccess System's pressure-sensing capability enhances the safety of epicardial access by reducing the risk of inadvertent right ventricular puncture. The system has shown promise in facilitating successful epicardial access in complex cases.
Safety Profile
Reported complications include potential risks associated with epicardial access, such as inadvertent puncture of the right ventricle. However, the pressure-sensing feature of the EpiAccess System aims to mitigate these risks by providing real-time feedback.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term outcome data. Further research is needed to establish comprehensive safety and efficacy profiles, particularly in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for epiaccess system?
The EpiAccess System is indicated for use in procedures requiring epicardial access, such as epicardial ablation for complex arrhythmias.
What outcomes have been reported in clinical studies?
Studies have reported that the EpiAccess System enhances safety by reducing the risk of right ventricular puncture during epicardial access.
What complications have been reported?
Reported complications include the risk of inadvertent right ventricular puncture, although the device's pressure-sensing feature aims to reduce this risk.
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.