Vipercross Support Catheters

FDA-Cleared Indications

• Percutaneous catheter use to provide support during intravascular procedures.
• Facilitation of catheterization and navigation within blood vessels.
• Use with compatible guidewires and interventional devices when catheter support is needed.

Clinical Applications

• Providing support during endovascular catheterization.
• Helping operators navigate compatible instruments through the vascular system.
• Supporting access and device delivery during selected venous interventions when consistent with the device labeling.
• Providing catheter backup during complex vascular access procedures.

Reported off-label uses

• Use as a support catheter in selected arterial interventions is described for support-catheter devices, but the specific use must be verified against the current product labeling.
• Use in challenging access or crossing situations outside the labeled indication may occur in clinical practice; this is physician-directed off-label use and is not established by the supplied FDA summary.

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

• Select the catheter size, length, and configuration according to the target vessel, access route, guidewire, and device being delivered.
• Confirm compatibility with the guidewire, introducer sheath, contrast agent, and other interventional equipment before use.
• Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for preparation, flushing, advancement, and withdrawal.
• The supplied FDA record does not state an MRI safety classification; MRI conditions should be confirmed in the current labeling before scanning.
• Potential catheter-related complications include vascular injury, bleeding, thrombosis, embolization, infection, dissection, and vessel perforation. Contraindications and warnings should be taken from the current instructions for use.