Hi-Torque Middle Support 012 Guide Wire with Hydrocoat Hydrophilic Coating

FDA-Cleared Indications

• Used to introduce and guide catheters and other compatible devices through the vascular system.
• Used to facilitate the delivery of liquid embolization agents to a selected vascular site.
• Intended for use by trained clinicians during image-guided endovascular procedures.

Clinical Applications

• Navigation of a catheter through blood vessels to a selected treatment site.
• Assistance with delivery of liquid embolization agents during vascular embolization procedures.

Reported off-label uses

• Guide-wire support during selected coronary or peripheral angioplasty and stent procedures may occur in clinical practice, but the specific FDA labeling provided here does not establish those uses.

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 wire is available in different lengths and diameters; the appropriate size depends on the access route, target vessel, catheter system and procedure.
• Hydrocoat is hydrophilic, so the wire must be prepared and kept wet according to the manufacturer’s instructions. A wet coating can reduce friction but may also reduce grip during handling.
• Compatibility with the intended catheter, embolization delivery system and other devices should be confirmed before use.
• The FDA record and supplied labeling do not establish MRI safety; MRI compatibility should be verified in the current manufacturer’s instructions for use.
• Potential complications are those associated with guide-wire and endovascular use, including vessel injury, dissection, perforation, thrombosis, embolization, bleeding and infection. Contraindications and warnings should be reviewed in the current labeling.