Platinum Plus Guidewire with Hydrophilic Coating

FDA-Cleared Indications

• Use to guide catheters during vascular procedures involving embolization with liquid agents.
• Use to assist navigation through blood vessels when positioning compatible interventional devices for the labeled embolization procedure.

Clinical Applications

• Catheter navigation during embolization with liquid embolic agents.
• Selective catheterization of blood vessels before delivery of a liquid embolic agent.
• Guidewire support for positioning compatible catheters in tortuous vascular anatomy during labeled embolization procedures.

Reported off-label uses

• Guidewire-assisted catheter navigation in other endovascular procedures not specifically covered by the device's FDA-cleared indication may occur in clinical practice. Such use is off-label and should be based on clinician judgment, device compatibility, and institutional policy.

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 hydrophilic coating generally must be activated with sterile saline according to the device instructions before use; the coating should be kept wet during handling.
• Available diameter and length options vary by model. The guidewire must be matched to the inner diameter, shape, and pressure limits of the selected catheter and other compatible devices.
• Advance and withdraw the wire under fluoroscopic guidance using gentle movements. Resistance should be evaluated rather than overcome with force because of the risk of vessel or device injury.
• MRI safety depends on the exact model and labeling. Confirm the current manufacturer MRI conditions before an MRI examination; do not assume that every Platinum Plus guidewire is MR safe.
• Potential complications include vessel injury, dissection, perforation, bleeding, thrombosis, vasospasm, infection, embolization, and wire damage or breakage. Contraindications, warnings, and preparation requirements should be checked in the current instructions for use.