Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating

FDA-Cleared Indications

• Facilitation of catheter placement during procedures involving liquid embolization agents.

Clinical Applications

• Guiding catheter placement when a liquid embolic agent will be delivered.
• Providing a wire pathway for catheter navigation through the vascular system.
• Supporting catheter positioning during selected vascular embolization procedures.

Reported off-label uses

• Guide-wire support for selected coronary or peripheral endovascular procedures outside the device's specific cleared indication may occur in clinical practice, but use should follow the manufacturer's labeling, institutional policy, and physician judgment.

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 was cleared under product code DQX as a catheter guide wire and is available in different lengths and diameters; selection depends on the catheter system, access route, vessel size, and procedural anatomy.
• Hydrophilic coatings require wetting according to the manufacturer's instructions. The wire should not be advanced or withdrawn forcefully, and its coating should be inspected for damage before use.
• Compatibility with the intended catheter, embolic delivery system, and introducer sheath should be confirmed before the procedure.
• As with other intravascular guide wires, potential complications include vessel injury, dissection, perforation, thrombosis, embolization, infection, and wire fracture or retention.
• MRI safety depends on the exact model and labeling. The specific device should be checked in the current manufacturer instructions before MRI; do not assume that a generic guide wire is MR safe.