📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of percutaneous access to the pericardial space.
- Use during procedures in which epicardial access is required.
- Real-time pressure waveform monitoring at the needle tip to help distinguish tissue planes during access.
Clinical Applications
- Obtaining percutaneous epicardial access for electrophysiology procedures.
- Supporting epicardial mapping and ablation procedures for selected complex arrhythmias.
- Helping confirm entry into the pericardial space through pressure waveform monitoring.
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.
Practical Considerations
- The system is intended for use by trained physicians familiar with pericardial access and the management of potential complications such as bleeding, cardiac injury and pericardial effusion.
- Access is generally performed with imaging guidance, such as fluoroscopy, echocardiography or both, and usually with local anesthesia plus moderate or deep sedation, depending on the procedure.
- Confirm the available needle dimensions, pressure-monitoring components and compatibility with the institution's pressure-monitoring equipment before use.
- MRI safety, including whether the device is MR Safe, MR Conditional or not suitable for MRI, should be confirmed in the current manufacturer labeling. Do not assume MRI compatibility from the FDA clearance alone.
- The device is intended for a single procedure unless the current labeling specifically states otherwise; it is not an implant designed to remain in the body.
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.