Sheath-In-Sheath Catheter 18Fr Model S00018 Sheath-In-Sheath Catheter 6 Fr Model S00019

FDA-Cleared Indications

• For use in procedures requiring the delivery of embolization coils.
• For vascular catheter-based interventions in which coaxial sheath access and controlled device delivery are needed.

Clinical Applications

• Delivery of embolization coils during vascular embolization procedures.
• Catheter-based treatment of selected aneurysms or pseudoaneurysms when coil occlusion is indicated.
• Coil embolization of selected arteriovenous malformations or other abnormal vascular connections.
• Vascular occlusion procedures performed in an interventional radiology or catheterization laboratory.

Reported off-label uses

• Use as a coaxial access platform for delivery of embolic agents other than coils may occur in clinical practice, but this should not be assumed to be within the device labeling.
• Use in neurointerventional procedures may be considered by specialists when the anatomy, device compatibility, and applicable labeling support it.

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 listed system includes an 18 Fr sheath-in-sheath catheter and a 6 Fr sheath-in-sheath catheter; clinicians should confirm the exact model and working dimensions before use.
• Confirm compatibility with the selected guidewire, microcatheter, embolization coil, contrast injector, and other procedural equipment.
• Insertion and manipulation should be performed under appropriate fluoroscopic or other imaging guidance by trained clinicians using sterile technique.
• The FDA record provided does not establish MRI safety; MRI use should be based on the current manufacturer labeling and device-specific MR conditions.
• Potential contraindications and complications depend on the access site, vascular anatomy, indication, and associated devices; review the current instructions for use before the procedure.