Intramax Iti Guide Catheter

FDA-Cleared Indications

• To facilitate placement of stents within the venous system.
• For percutaneous catheter-based vascular procedures involving venous access.

Clinical Applications

• Providing a pathway for delivery and positioning of venous stents.
• Supporting image-guided treatment of venous stenosis or obstruction when a venous stent is indicated.
• Facilitating catheter-based access to the venous system during interventional vascular procedures.

Reported off-label uses

• Providing support for delivery of other therapeutic or diagnostic devices in venous interventions when the specific use is not included in the device 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 appropriate catheter size and configuration depend on the access site, target vessel, anatomy, and device being delivered.
• The catheter is introduced through percutaneous vascular access and should be manipulated under appropriate fluoroscopic or other imaging guidance.
• Compatibility with guidewires, stents, introducer sheaths, and other devices should be confirmed before use.
• The available FDA record does not establish MRI safety; MRI conditions should be verified in the current product labeling before scanning.
• Potential contraindications and complications include unsuitable vascular anatomy, vessel injury, bleeding, thrombosis, infection, embolization, and adverse reactions to contrast or medications used during the procedure.