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epiaccess system
Epiep
Summary: The EpiAccess System by Epiep is designed for epicardial access in complex arrhythmia treatments. Key evidence highlights its innovative pressure-sensing needle tip for safer procedures.
FDA Clearance Information
Pathway
510K
Number
K170831 ↗
Decision Date
May 9, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The EpiAccess System received FDA clearance through the 510(k) pathway on May 9, 2017. Manufactured by Epiep, it is 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 for treating complex arrhythmias. It features a needle with an embedded pressure sensor for real-time pressure waveform monitoring, enhancing procedural safety.
Clinical Applications
The device is commonly used in scenarios where epicardial ablation is necessary, particularly when endocardial approaches are insufficient. It is valuable in treating arrhythmias that are refractory to conventional methods.
Evidence Summary
The literature includes three studies: one published in 2018 and two registered clinical trials. These studies encompass a range of methodologies, including a multicenter human experience study.
Reported Outcomes
Published studies report that the EpiAccess System's pressure-sensing needle improves the safety and efficacy of epicardial access by reducing the risk of inadvertent punctures. The device's real-time feedback is noted to enhance procedural confidence.
Safety Profile
Reported complications include the potential for inadvertent right ventricular puncture, although the pressure-sensing capability of the device aims to mitigate this risk. No specific adverse events are detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed outcomes and safety data. Further research is needed to establish long-term efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for epiaccess system?
The EpiAccess System is indicated for epicardial access in the treatment of complex arrhythmias, particularly when endocardial approaches are inadequate.
What outcomes have been reported in clinical studies?
Studies report improved safety and efficacy in epicardial access due to the device's pressure-sensing capabilities.
What complications have been reported?
Reported complications include the risk of inadvertent right ventricular puncture, although the device is designed 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.