PTFE Peelable Introducer

FDA-Cleared Indications

• Vascular access for the introduction of catheters and other intravascular devices.
• Use during procedures requiring placement of embolization devices, including embolization coils.
• Percutaneous access to the vascular system when a peelable introducer sheath is appropriate.

Clinical Applications

• Providing vascular access for catheter-directed embolization procedures.
• Introducing catheters used to deliver embolization coils or other embolic materials.
• Maintaining access while a catheter or device is positioned, followed by peel-away sheath removal.
• Use in interventional radiology, interventional cardiology, and related catheter-based vascular procedures.

Reported off-label uses

• Use as a peel-away access sheath for selected non-embolization vascular or structural-heart procedures when the treating clinician determines that the device is appropriate.
• Use for access to vessels outside the device’s specifically labeled clinical application, based on operator judgment and institutional practice.

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 sheath size and length to match the catheter or device diameter, access vessel, and patient anatomy.
• Use imaging guidance and standard sterile vascular-access technique; common access sites may include the femoral, radial, brachial, or jugular vessels, depending on the procedure.
• The sheath is peeled away carefully after the catheter or device is in position. Operators should stabilize the inserted device during removal to avoid displacement or vessel injury.
• MRI safety depends on the exact product configuration and whether any radiopaque markers or other components remain in the patient. Check the current manufacturer labeling before MRI.
• Potential complications include bleeding, hematoma, vessel injury, thrombosis, infection, air embolism, and device-related vascular trauma. Contraindications and precautions should follow the current instructions for use and the patient’s clinical condition.