Piolax Hydrophilic Guidewire

FDA-Cleared Indications

• Used with catheters to facilitate navigation through the vascular system.
• Used in procedures requiring delivery of embolization agents, including liquid embolics, through a catheter.
• Used to access and selectively catheterize blood vessels during endovascular procedures.

Clinical Applications

• Guiding catheter systems during vascular access and selective catheterization.
• Facilitating delivery of embolization agents to treat vascular abnormalities or intentionally block blood flow.
• Supporting endovascular procedures in which a catheter must be advanced through narrow, tortuous, or branching vessels.

Reported off-label uses

• Guidewire support during angiography, angioplasty, or other catheter-based vascular procedures when the specific use is outside 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

• Select the wire diameter, length, tip configuration, and stiffness for the catheter system, access route, and vascular anatomy.
• Confirm compatibility with the intended catheter and embolic delivery system before use.
• Hydrophilic coatings require appropriate wetting and handling according to the instructions for use; do not advance the wire against significant resistance.
• The record provided does not establish MRI safety. Check the current product labeling and the exact wire model before MRI exposure.
• Potential complications include vessel trauma, dissection, perforation, thrombosis, vasospasm, infection, and wire fracture or separation.