Cordis Avanti Catheter Sheath Introducer

FDA-Cleared Indications

• For introduction of catheters into the vascular system during diagnostic or interventional procedures.
• For vascular access through the arterial or venous systems.

Clinical Applications

• Providing arterial access for angiography and catheter-based interventions.
• Providing venous access for diagnostic or interventional catheter procedures.
• Maintaining vascular access while catheters are inserted, exchanged, or removed.
• Supporting catheter-based procedures performed by interventional cardiology and interventional radiology.

Reported off-label uses

• Use as an access sheath during embolization procedures when the selected size and configuration are appropriate.
• Use for access in complex vascular interventions beyond the specific procedures described in the product labeling.

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 device is available in multiple sheath sizes; the selected size should match the catheter diameter and the target vessel.
• Insertion is generally performed over a guidewire using standard percutaneous vascular access technique and imaging guidance when appropriate.
• The sheath and dilator should be inspected before use and handled according to the current manufacturer instructions for use.
• The FDA record does not establish that the device is MR safe or MR conditional; MRI compatibility should be confirmed in the current labeling before scanning.
• Potential complications of vascular sheath placement include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and contrast-related complications from the associated procedure.