Hi-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating Acs Hi-Torque Balance Middleweight Guide Wire with Hydg

FDA-Cleared Indications

• Used to guide and position catheters within blood vessels during intravascular procedures.
• Intended for use with compatible catheter systems when vascular access and catheter navigation are required.
• The product code identifies it as a catheter guide wire under 21 CFR 870.1330.

Clinical Applications

• Guiding diagnostic or therapeutic catheters through the vascular system.
• Facilitating catheter placement during coronary catheterization and percutaneous coronary intervention when consistent with the device labeling.
• Supporting placement of balloon or stent-delivery catheters in appropriately selected vascular procedures.
• Navigating tortuous or difficult vascular anatomy with a hydrophilic-coated guide wire.

Reported off-label uses

• Guide-wire support for selected peripheral vascular interventions when the specific product labeling does not identify that vascular territory.
• Use in other endovascular procedures requiring catheter navigation, when selected and handled by an appropriately trained clinician.

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

• Available guide-wire diameter and length should match the target anatomy, access route, catheter system, and procedural objective.
• The hydrophilic coating becomes lubricious when properly wetted; follow the product instructions for preparation, flushing, handling, and storage.
• Use only with compatible catheters and equipment. Do not force advancement or withdrawal if resistance is encountered, because vessel injury or wire damage can occur.
• MRI safety depends on the exact product configuration and current manufacturer labeling. Confirm MR status before exposing the wire or any retained component to an MRI environment.
• Potential complications include vessel spasm, dissection, perforation, thrombosis, embolization, infection, wire fracture, and bleeding. Contraindications and warnings should be reviewed in the current instructions for use.