Merit Hydrophilic Guidewire

FDA-Cleared Indications

• Used to facilitate the placement and manipulation of catheters and other interventional devices within the vascular system.
• Intended for use by trained clinicians during diagnostic and therapeutic endovascular procedures.

Clinical Applications

• Guidewire-assisted catheter navigation during peripheral vascular angiography and intervention.
• Guidewire-assisted navigation during cerebral or neurovascular angiography when the specific wire configuration is appropriate.
• Navigation through vessels during access and catheter placement, including radial artery access procedures.
• Support for advancing compatible vascular devices under fluoroscopic or other appropriate imaging guidance.

Reported off-label uses

• Use in selected nonvascular systems, such as ureteral navigation, has been described for hydrophilic guidewire technology but may not be covered by this device's FDA vascular labeling. Such use should follow institutional policy, product labeling and specialist judgment.

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 diameter, length, tip shape and stiffness vary by model; select a wire that matches the access site, target anatomy and compatible catheter or sheath.
• Hydrophilic wires should be prepared and lubricated according to the manufacturer's instructions. Avoid advancing or withdrawing against resistance, and do not torque the wire excessively.
• Use imaging guidance and maintain control of the wire tip to reduce the risk of vessel injury, dissection, perforation or wire fracture.
• MRI safety depends on the exact model and labeling. Confirm MR Safe, MR Conditional or MR Unsafe status before an MRI examination; do not assume that all guidewires have the same designation.
• The wire is a sterile, single-use device and is not intended to remain implanted after the procedure. Do not reuse, reprocess or resterilize unless the specific labeling permits it.