Guider Catheter Introducer

FDA-Cleared Indications

• Introduction of catheters into the vascular system during interventional procedures.
• Use as an access or guiding pathway for catheter-based vascular procedures, according to the device labeling.

Clinical Applications

• Providing vascular access for catheter-based diagnostic procedures.
• Providing a pathway for therapeutic catheter placement in blood vessels.
• Supporting catheter delivery during embolization procedures when consistent with the device labeling and procedural requirements.

Reported off-label uses

• Use as a guiding or support catheter during selected neurovascular interventions, when compatible with the anatomy and procedure.
• Use during selected peripheral arterial or venous interventions beyond the specific applications 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

• The appropriate device size depends on the target vessel, access site, catheter diameter and procedural anatomy.
• Compatibility with the intended catheter, guidewire and other accessories must be confirmed before use.
• Placement should be performed with appropriate vascular imaging guidance and careful handling to reduce vessel trauma, dissection, perforation or bleeding.
• The available FDA record does not establish MRI safety; MRI use should follow the current manufacturer labeling and device-specific MR conditions.
• Contraindications and precautions include inability to obtain suitable vascular access, infection at the access site, significant vessel disease or any patient-specific condition identified in the manufacturer’s instructions for use.