Sofia Ex Intracranial Support Catheter

FDA-Cleared Indications

• Used to provide access to the neurovasculature during endovascular procedures.
• Used to provide support for the delivery of interventional devices or therapeutic agents in the brain's blood vessels.

Clinical Applications

• Providing intracranial vascular access during neuroendovascular procedures.
• Supporting delivery of compatible neurovascular devices during an indicated intervention.
• Supporting catheter-based treatment of cerebrovascular disease when neurovascular access is required.

Reported off-label uses

• Use as an intermediate or distal-access catheter during mechanical thrombectomy for acute ischemic stroke, when used outside the specific cleared labeling or with a different procedural purpose.
• Use as an adjunctive support catheter during selected aneurysm or intracranial stenosis interventions when the application is not specifically described in the device labeling.

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 catheter is available in different configurations and sizes; the selected size must match the target vessel, access system, and compatible devices.
• It is designed for use with standard neurointerventional equipment and requires fluoroscopic or other appropriate imaging guidance.
• Careful manipulation is required because cerebral vessels are small and vulnerable to spasm, dissection, perforation, or embolic complications.
• MRI safety depends on the exact device configuration and labeling; users should verify the current manufacturer instructions before MRI exposure.
• Contraindications, warnings, and compatibility limits should be checked in the current instructions for use before the procedure.