Epicardial Access System

FDA-Cleared Indications

• Access to the pericardial space during electrophysiology procedures.
• Use in procedures requiring access to the epicardial surface of the heart.

Clinical Applications

• Obtaining percutaneous access to the pericardial space for electrophysiology procedures.
• Providing a pathway for epicardial mapping and ablation of ventricular arrhythmias.
• Supporting access for other electrophysiology interventions performed on the epicardial surface of the heart.

Reported off-label uses

• Epicardial pacing or cardiac lead implantation when pericardial access is clinically required.
• Epicardial access for selected repeat procedures or treatment of complex ventricular arrhythmia substrates.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The system is used with fluoroscopy and other imaging or electrophysiology guidance to identify the pericardial space and reduce the risk of injury.
• Access is generally obtained through a subxiphoid or parasternal approach, depending on patient anatomy and operator technique.
• Device components, wire compatibility, and available sizes should be confirmed in the current manufacturer instructions for use before the procedure.
• Potential complications include bleeding, hemopericardium, cardiac or coronary injury, pneumothorax, infection, and damage to nearby abdominal or thoracic structures.
• MRI safety and conditions depend on the specific components and whether any other implanted devices remain in the patient; the current labeling should be checked before MRI.