Modification to Convoy Advanced Delivery Sheath

FDA-Cleared Indications

• Used to facilitate the delivery and placement of embolization coils during endovascular procedures.
• Intended for use when controlled vascular occlusion is required as part of an embolization procedure.

Clinical Applications

• Delivery of embolization coils to a selected blood vessel.
• Endovascular treatment of vascular abnormalities requiring vessel occlusion.
• Embolization procedures performed to reduce or stop blood flow to a targeted vascular territory.

Reported off-label uses

• Use as a delivery pathway for embolic devices other than the coils specified in the applicable device labeling may occur in clinical practice, but this should not be assumed to be an FDA-cleared indication.
• Use in vascular territories or procedural applications outside the device labeling may be considered by specialists only when clinically justified and consistent with institutional policies.

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 sheath must be matched to the selected embolization coil system, guidewire, catheter, and target-vessel anatomy.
• Appropriate sheath size and length depend on the access site, vascular route, target vessel, and required device compatibility.
• Use fluoroscopic imaging and careful catheter manipulation to reduce the risk of vessel injury, dissection, perforation, or unintended embolization.
• The record provided does not establish MRI safety or conditional labeling; MRI compatibility should be confirmed in the current manufacturer instructions for use.
• Contraindications, warnings, and handling requirements should be reviewed in the current FDA-cleared labeling before use.