Cordis Peel-Away Insertion Tool

FDA-Cleared Indications

• Use as an accessory for the insertion of embolization coils into the vascular system.
• Facilitate placement of embolization devices during endovascular treatment of vascular abnormalities, including aneurysms and vascular malformations, when consistent with the applicable device labeling.

Clinical Applications

• Insertion of embolization coils during endovascular treatment of intracranial aneurysms.
• Insertion of coils for embolization of arteriovenous malformations.
• Placement of embolization coils in selected peripheral or visceral aneurysms and pseudoaneurysms.
• Use during catheter-based embolization procedures in which a peel-away sheath is appropriate for device delivery.

Reported off-label uses

• Use with selected non-coil embolic devices or delivery systems when the device dimensions and intended use are compatible may occur in clinical practice, but this should follow applicable labeling, institutional policy, and physician judgment.
• Use in embolization procedures involving vessels or indications not specifically described in the applicable labeling may be considered off-label and is not a recommendation for use.

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 tool is available in different sizes; the selected size must match the target vessel, introducer or catheter system, and embolization device.
• Operators should be trained in advancing, positioning, and peeling the sheath without dislodging the embolization device or injuring the vessel.
• Compatibility with the specific coil, catheter, guidewire, and delivery system should be confirmed before use; do not assume compatibility across manufacturers.
• MRI safety information is device- and model-specific. The FDA record alone does not establish that every configuration is MR Safe or MR Conditional; consult the current Cordis labeling.
• As a vascular access accessory, it may be unsuitable when the intended access route is too small, tortuous, diseased, or otherwise unable to accommodate the selected device. Standard contraindications and warnings for the embolization procedure also apply.