Philips Integris V5000 and BV5000

FDA-Cleared Indications

• Use in diagnostic and interventional procedures requiring fluoroscopic and angiographic X-ray imaging.
• Use to provide imaging guidance during procedures involving the vascular system.
• Use during embolization procedures involving the delivery of liquid embolic agents.

Clinical Applications

• Fluoroscopic guidance for catheter-based vascular procedures.
• Angiographic visualization of blood vessels during interventional procedures.
• Imaging guidance for embolization with liquid embolic agents.
• Real-time imaging during minimally invasive procedures performed in an interventional radiology or cardiac catheterization suite.

Reported off-label uses

• Use for image guidance during other catheter-based interventions not specifically described in the available FDA summary, when determined appropriate by the treating clinician.

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

• These are fixed-room X-ray fluoroscopy systems, not MRI scanners; patients and staff must follow applicable radiation-safety procedures.
• Image quality depends on patient positioning, system settings, contrast administration, motion control and appropriate selection of imaging angles.
• The imaging system does not determine compatibility with an embolic agent or catheter; clinicians must separately confirm that the selected devices and materials are approved and compatible.
• Patient size, table weight limits, access to the treatment area and required C-arm or gantry positioning should be assessed before the procedure.
• The systems require qualified operators, routine maintenance and quality-control testing; availability and performance may vary with system age and upgrades.