Epicardial Access System

FDA-Cleared Indications

• Access to the pericardial space during cardiac electrophysiology procedures.
• Use in procedures requiring percutaneous epicardial access under imaging guidance.

Clinical Applications

• Obtaining pericardial access for epicardial electrophysiology procedures.
• Supporting epicardial mapping and ablation procedures for ventricular arrhythmias when indicated.
• Providing access for other cardiac procedures that require entry into the pericardial space.

Reported off-label uses

• Epicardial pacing or defibrillation lead implantation in selected patients.
• Epicardial access for selected repeat ablation procedures when conventional approaches are inadequate.

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 intended for use by trained physicians familiar with cardiac anatomy, pericardial access and electrophysiology procedures.
• Access is generally performed with fluoroscopy and may be supplemented by echocardiography or other imaging; general anesthesia or procedural sedation may be used depending on the case.
• Device configuration and working length should be selected according to the patient’s anatomy and the planned procedure. Confirm compatibility with guidewires, sheaths and other accessories before use.
• Potential complications include bleeding, hemopericardium, cardiac or coronary injury, pneumothorax, pericarditis, arrhythmia and cardiac tamponade.
• MRI safety, reprocessing requirements, storage conditions and size options depend on the specific system components and current manufacturer labeling; verify the product instructions before use.