Hydrophilic Guidewire

FDA-Cleared Indications

• Used to facilitate the placement and exchange of catheters within the vascular system.
• Used to provide guidance for intravascular catheters during diagnostic and therapeutic procedures.
• Intended for use by qualified clinicians in vascular procedures when guidewire support is needed.

Clinical Applications

• Guiding diagnostic catheters through blood vessels
• Supporting catheter placement during endovascular procedures
• Facilitating catheter exchange within the vascular system
• Navigating tortuous vascular anatomy under fluoroscopic imaging

Reported off-label uses

• Use in neuroendovascular procedures such as selective cerebral angiography or embolization may be described in clinical practice, but the specific application depends on the device labeling, wire specifications, and institutional protocols.
• Use during uterine artery embolization or transradial coronary angiography may occur in practice, but clinicians should confirm that the specific wire is labeled and suitable for the intended procedure.

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 shape, stiffness, and coating for the access site, target vessel, catheter, and intended procedure.
• Confirm compatibility with the catheter or sheath and use fluoroscopic imaging for advancement and positioning.
• Hydrophilic coatings require adequate wetting according to the instructions for use; a dry wire may have increased friction and coating damage.
• Do not force advancement or withdrawal. Resistance may indicate spasm, vessel injury, entrapment, or device incompatibility.
• MRI safety depends on the specific model and labeling; verify the manufacturer's MRI conditions before scanning.