Tsp Crosser Transseptal Access System

FDA-Cleared Indications

• Used to facilitate transseptal access to the left atrium during cardiac catheterization procedures.
• Used to support catheter navigation across the interatrial septum when left-heart access is required.

Clinical Applications

• Establishing transseptal access for left atrial electrophysiology procedures.
• Providing access for catheter-based treatment of atrial fibrillation and other left atrial arrhythmias.
• Supporting left atrial catheter navigation during structural heart procedures when transseptal access is required.

Reported off-label uses

• Use in selected complex left-heart catheterization procedures outside the device's specific cleared labeling, based on operator judgment and institutional practice.

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 device must be compatible with the guidewire, dilator, sheath, and catheter system used for the planned procedure.
• Transseptal access should be performed by clinicians trained in transseptal puncture and left-heart catheterization, using appropriate fluoroscopic, echocardiographic, or other imaging guidance.
• Patient-specific anatomy, including an enlarged atrium, prior septal repair, thrombus, or an implanted septal device, may affect feasibility and risk.
• MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume the system is MRI safe after implantation or use.
• Potential complications of transseptal access include bleeding, cardiac perforation, pericardial effusion or tamponade, embolization, arrhythmia, and unintended vascular or intracardiac injury.