Asahi Corsair Armet

FDA-Cleared Indications

• Used during percutaneous vascular procedures to facilitate guidewire navigation and provide support for guidewire manipulation.
• Intended for use in adult patients undergoing catheter-based vascular intervention.
• Used when catheter support is needed to access or treat vessels with challenging anatomy.

Clinical Applications

• Supporting guidewire advancement during catheter-based vascular interventions.
• Facilitating access through tortuous or difficult vascular anatomy.
• Providing support during percutaneous treatment of vascular disease when standard catheter support is insufficient.

Reported off-label uses

• Use in selected peripheral vascular interventions beyond the device's specifically described coronary or vascular application may occur in clinical practice, but this should be evaluated by the treating physician and is not necessarily covered by the FDA 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 device is available in different sizes and configurations; selection depends on the target vessel, access route, guidewire, and planned intervention.
• It is used with compatible guidewires and catheter systems. Operators should confirm compatibility in the current product instructions for use.
• The catheter is advanced under fluoroscopic or other appropriate imaging guidance and should not be forced through resistance.
• MRI safety depends on the specific device configuration and labeling. The current manufacturer instructions should be checked before MRI; do not assume the device is MR safe or MR conditional.
• Potential risks of catheter-based vascular procedures include vessel injury, dissection, perforation, bleeding, thrombosis, embolization, infection, contrast reaction, and radiation exposure.