Silverspeed Hydrophilic Guidewire X-Celerator Hydrophilic Exchange Guidewire X-Pedion Hydrophilic Guidewire Mirage Hy

FDA-Cleared Indications

• Used to facilitate the placement and exchange of catheters during diagnostic and interventional procedures.
• Intended for navigation through blood vessels under fluoroscopic or other imaging guidance.
• Used with compatible catheters and accessories in adults when wire guidance is clinically indicated.

Clinical Applications

• Guiding catheters during diagnostic angiography and other endovascular procedures.
• Facilitating catheter advancement through tortuous or narrowed vessels.
• Supporting catheter exchange when maintaining vascular access is necessary.
• Assisting selective catheterization of target vessels under imaging guidance.

Reported off-label uses

• Guidewire support during selected nonvascular catheter procedures, such as endoscopic retrograde cholangiopancreatography, when the specific product labeling and institutional policies permit it.
• Use in selected embolization procedures, including uterine artery embolization, as part of catheter navigation; the exact indication depends on the individual product 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

• Available dimensions, tip shapes, stiffness, and radiopaque-marker configurations vary by model; choose a wire compatible with the catheter, access sheath, and target anatomy.
• The hydrophilic coating should be activated and maintained according to the instructions for use. Avoid advancing or withdrawing the wire against significant resistance.
• Use fluoroscopy or other appropriate imaging to monitor the wire tip and reduce the risk of vessel injury, perforation, dissection, or entanglement.
• MRI safety is model-specific. Confirm the exact guidewire's current labeling before MRI; do not assume that all hydrophilic guidewires are MR safe or MR conditional.
• Potential complications include bleeding, thrombosis, embolization, vasospasm, vessel dissection, perforation, infection, and device fracture or retention.