Merit Hydrophilic Guide Wire

FDA-Cleared Indications

• Used as a guide for the placement and exchange of catheters during diagnostic or interventional procedures.
• Intended for navigation through anatomical pathways, including vascular pathways, to facilitate catheter placement.
• Use is limited to the specific wire configurations, sizes, and anatomical applications described in the manufacturer’s labeling.

Clinical Applications

• Guiding diagnostic or interventional catheters through blood vessels.
• Supporting catheter exchange during endovascular procedures.
• Navigating narrow, curved, or tortuous vascular pathways.
• Facilitating placement of compatible catheters or other devices during image-guided procedures.

Reported off-label uses

• Guide-wire assistance during urinary tract or ureteral access may be used in clinical practice, but the specific Merit device labeling should be checked before use.
• Use in other nonvascular body passages may occur with guide-wire products, but should not be assumed to be cleared for this device without confirming its 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 size, length, tip shape, and stiffness should match the access route, catheter, and procedure.
• The hydrophilic coating generally requires wetting with sterile fluid before use and should be kept moist according to the instructions for use.
• Confirm compatibility with the intended catheter or device, including guide-wire diameter and working length.
• Use fluoroscopic or other appropriate imaging guidance and avoid forceful advancement, which can cause dissection, perforation, bleeding, or wire damage.
• MRI safety is configuration-specific; verify the exact model’s FDA labeling and MR conditions before an MRI examination.