đź“Š Evidence-Based Reference
Pericross Epicardial Access Kit
Circa Scientific
Summary: The Pericross Epicardial Access Kit is designed for percutaneous epicardial access, primarily used in cardiac procedures. Key evidence highlights its innovative approach in facilitating access with potential safety benefits.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K243954 ↗
Decision Date ?
April 24, 2025
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Pericross Epicardial Access Kit by Circa Scientific was cleared via the FDA 510(k) pathway on April 24, 2025. It is classified as a Class 2 device under product code DYB.
What It Is
The Pericross Epicardial Access Kit is a medical device used to gain percutaneous access to the epicardial space. It is intended for use in cardiac procedures such as ablation and lead placement, offering a minimally invasive approach.
FDA-Cleared Indications
- Percutaneous access to the epicardial space for cardiac procedures.
Clinical Applications
- Obtaining percutaneous access to the space surrounding the heart.
- Providing access for cardiac procedures performed on or near the epicardial surface.
- Supporting procedures such as epicardial cardiac ablation when epicardial access is clinically indicated.
- Supporting placement of cardiac leads that require access to the epicardial surface.
Evidence Summary
The available literature includes 6 studies ranging from 2019 to 2025, featuring various study designs such as animal models and feasibility studies. These studies explore the device's application and safety profile.
Reported Outcomes
Published studies report that the Pericross Epicardial Access Kit facilitates effective epicardial access with potential improvements in procedural efficiency. The innovative design is noted for reducing the risk of complications associated with traditional methods.
Safety Profile
Reported complications include potential risks of coronary artery damage and ventricular injury, as noted in the literature. However, the device's design aims to mitigate these risks through improved access techniques.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale clinical trials. Further research is needed to validate findings in diverse patient populations and to explore long-term outcomes.
Practical Considerations
- The kit is intended for use by trained cardiac or interventional specialists with imaging guidance and appropriate management of potential pericardial complications.
- The specific needle, wire, dilator, sheath, and accessory sizes should be confirmed in the current manufacturer’s instructions for use.
- Compatibility with guidewires, catheters, sheaths, imaging equipment, and other accessories should be verified before the procedure.
- MRI safety or conditional status should be confirmed from the current device labeling; it should not be assumed from the 510(k) clearance alone.
- Potential complications include bleeding, pericardial effusion or tamponade, injury to the heart or nearby structures, infection, arrhythmia, and the need for urgent surgical treatment.
Frequently Asked Questions
What are the clinical indications for Pericross Epicardial Access Kit?
The device is indicated for use in procedures requiring percutaneous epicardial access, such as cardiac ablation and pacemaker lead placement.
What outcomes have been reported in clinical studies?
Studies report effective epicardial access with potential improvements in procedural efficiency and safety.
What complications have been reported?
Safety data indicate risks of coronary artery damage and ventricular injury, although the device design aims to reduce these complications.
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.