Acs Hi-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic Coating

FDA-Cleared Indications

• Use as a guide wire to facilitate the placement and positioning of catheters and other compatible intravascular devices during vascular procedures.
• Use in procedures requiring navigation through the vascular system under imaging guidance.

Clinical Applications

• Navigating a catheter through the peripheral or coronary vasculature during endovascular procedures.
• Providing support for advancing compatible balloon catheters, stent-delivery systems, or other intravascular devices.
• Crossing tortuous or narrowed vascular segments when guide-wire support is needed.
• Facilitating catheter positioning during vascular diagnostic or interventional procedures.

Reported off-label uses

• Guide-wire support during selected endovascular embolization procedures when compatible with the catheter system and procedural plan.
• Use in challenging vascular anatomy beyond the specific configurations or vessels described in the device 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

• Select the wire diameter, length, stiffness, and tip configuration for the target vessel, access route, and compatible catheter system.
• The Hydrocoat hydrophilic coating must be wetted and handled according to the instructions for use; avoid letting the coating dry during the procedure.
• Use fluoroscopic or other appropriate imaging guidance, and do not force the wire against resistance because vessel injury, dissection, perforation, or wire damage can occur.
• Confirm compatibility with the catheter, introducer, guide catheter, and other devices before use. Product-specific MRI safety information should be checked in the current labeling; do not assume the wire is MRI safe.
• This is a single-use sterile device unless the current labeling states otherwise. It is not intended to remain implanted after the procedure.