Volcano Preview Forward-Looking IVUS System

FDA-Cleared Indications

• Intravascular ultrasound imaging to assist with the placement of venous stents.
• Intravascular ultrasound imaging to assess venous stents after placement.

Clinical Applications

• Imaging veins before venous stent placement.
• Guiding the positioning and deployment of venous stents.
• Assessing venous stent expansion and apposition after deployment.
• Evaluating the treated venous segment during an interventional procedure.

Reported off-label uses

• Intravascular imaging to evaluate non-stented venous obstruction or thrombosis.
• Intravascular imaging during complex venous recanalization procedures.
• Intravascular imaging of arterial lesions or arterial stents, when used outside 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 system requires compatible intravascular catheter and imaging-console components; users should confirm the approved catheter, guidewire, and access-system specifications before the procedure.
• It is introduced through a vascular access sheath or catheter and is manipulated under fluoroscopic or other appropriate imaging guidance by trained clinicians.
• The device is intended for intravascular imaging and does not itself remove thrombus, open an occlusion, or deploy a stent.
• MRI safety depends on the specific catheter and system configuration. The device should not be considered MRI safe or conditional without checking the current manufacturer labeling.
• Potential procedure-related risks include vascular injury, bleeding, infection, thrombosis, embolization, contrast reaction, and complications from the access site.