Silverstreak Hydrophilic Guidewire

FDA-Cleared Indications

• Used to facilitate the placement and positioning of catheters within the vascular system.
• Used as a guide for catheter navigation during endovascular procedures.
• The product code identifies it as a catheter guidewire regulated under 21 CFR 870.1330.

Clinical Applications

• Guiding catheters through the vascular system during diagnostic angiography.
• Supporting catheter placement for endovascular interventions.
• Navigating tortuous or complex vascular anatomy when catheter positioning is required.
• Facilitating catheter exchanges during vascular procedures.

Reported off-label uses

• Guidewire assistance during selected nonvascular catheter procedures, such as endoscopic retrograde cholangiopancreatography, when the specific product labeling and local practice permit it.
• Guidewire assistance during selected embolization procedures, such as uterine artery embolization, when used in accordance with institutional protocols and applicable labeling.

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 appropriate wire diameter, length, tip shape, and stiffness depend on the catheter, access route, target anatomy, and procedure.
• The hydrophilic coating must be wetted according to the instructions for use; dry handling can increase friction and may damage the coating.
• Use only with compatible catheters and accessories. Do not force the wire if resistance, entrapment, or unusual movement occurs.
• MRI safety status is product- and model-specific and should be confirmed in the current manufacturer labeling; do not assume that a guidewire is MRI safe.
• Potential complications include vascular injury, perforation, dissection, thrombosis, embolization, infection, and device fracture or coating separation.