Cordis Brite Tip Envoy Guiding Catheter

FDA-Cleared Indications

• Facilitation of the introduction of interventional devices into the vascular system.
• Use during vascular diagnostic and therapeutic procedures requiring a guiding catheter.

Clinical Applications

• Providing access and support for the introduction of interventional devices during vascular procedures.
• Supporting catheter-based diagnostic procedures in the vascular system.
• Supporting catheter-based therapeutic procedures in the vascular system.

Reported off-label uses

• Use as an access or support catheter in selected venous interventions, including mechanical thrombectomy or venous stenting, when the specific configuration and procedure are not covered by 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

• Available sizes and configurations should be matched to the target vessel, access route, anatomy, and interventional device being used.
• The catheter should be advanced and manipulated under appropriate imaging guidance to reduce the risk of vessel injury, dissection, perforation, or spasm.
• Compatibility with guidewires, sheaths, contrast agents, and other interventional devices must be confirmed before use.
• MRI safety depends on the exact catheter model and whether it is present in the patient; the current manufacturer labeling should be checked before MRI.
• Contraindications, warnings, and instructions for use should be reviewed before the procedure. The catheter is intended for temporary procedural use rather than long-term implantation.