Concentric Balloon Guide Catheter Model 90072

FDA-Cleared Indications

• Use as a percutaneous catheter to obtain vascular access and guide other devices during endovascular procedures.
• Use for temporary balloon occlusion of a blood vessel when indicated during an endovascular intervention.
• Use in procedures requiring catheter-based access and support within the vascular system.

Clinical Applications

• Providing access and support for placement of other endovascular devices.
• Temporary control or occlusion of blood flow during a catheter-based vascular procedure.
• Guiding compatible wires, catheters, or therapeutic devices through the vascular system.
• Supporting endovascular treatment in vessels appropriate for the catheter's labeled size and configuration.

Reported off-label uses

• Temporary proximal flow arrest during selected neurointerventional procedures, such as clot-retrieval techniques, when the device's labeling does not specifically cover that application.
• Flow control or embolic protection during selected peripheral vascular interventions outside the device's specific 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 appropriate catheter size must match the target vessel and the compatible guidewire or device; clinicians should verify the manufacturer's specifications before use.
• Balloon inflation requires careful monitoring because excessive inflation or prolonged occlusion can injure the vessel or reduce blood flow.
• Use requires clinicians trained in percutaneous endovascular techniques and imaging-guided catheter navigation.
• MRI safety depends on the exact device labeling and whether the catheter is present, implanted, or packaged; do not assume it is MRI safe without confirming the manufacturer’s current instructions.
• Potential contraindications and risks include unsuitable vessel size or anatomy, vessel injury, thrombosis, embolization, bleeding, infection, and complications related to vascular access.