Convoy Advanced Delivery Sheath

FDA-Cleared Indications

• Delivery of embolization coils during endovascular procedures.
• Use as a vascular conduit to facilitate placement of therapeutic embolization devices.

Clinical Applications

• Endovascular coil embolization of aneurysms and pseudoaneurysms.
• Coil embolization to occlude selected arteries or veins when stopping blood flow is clinically indicated.
• Delivery of embolization coils during treatment of vascular malformations.

Reported off-label uses

• Use in selected embolization procedures with coil types or clinical applications outside the device-specific cleared labeling may occur in practice, but this is off-label and should be determined by the treating specialist.

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 lengths must be matched to the access vessel, target anatomy, and embolization coil system used.
• The sheath is intended for sterile, image-guided intravascular use by trained specialists, commonly through femoral or radial arterial access depending on the procedure.
• Compatibility with the selected embolization coils, guidewires, and other delivery components should be confirmed before use.
• The FDA record provided does not establish that the device is MR Safe or MR Conditional; MRI status should be verified in the current manufacturer labeling.
• Potential contraindications and risks include unsuitable vascular anatomy, vessel injury, bleeding, infection, thrombosis, embolization to an unintended location, and contrast-related complications.