Release 2 of Philips Integris Series V5000 BV5000 H5000 BH5000 HM2000 Systems

FDA-Cleared Indications

• Use during procedures involving liquid embolization agents.
• Provide fluoroscopic imaging to guide the placement of embolic materials in the treatment of vascular abnormalities.

Clinical Applications

• Fluoroscopic guidance during liquid embolization procedures.
• Imaging to guide catheter placement and delivery of liquid embolic materials.
• Real-time visualization during treatment of vascular abnormalities when liquid embolization is performed.

Reported off-label uses

• Angiography and catheter-directed vascular interventions not specifically described in the FDA indication.
• Fluoroscopic guidance for selected interventional cardiology procedures.
• Fluoroscopic guidance for selected neurointerventional procedures.

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

• This is an X-ray fluoroscopy system, not an MRI system; it should not be taken into an MRI scanner room unless the specific system and room configuration are documented as safe.
• The system uses ionizing radiation, so radiation dose, fluoroscopy time and image quality should be managed according to institutional protocols.
• Compatibility with catheters, guidewires and embolic agents depends on the specific procedure and accessories; users should verify compatibility in the applicable device and accessory labeling.
• The record covers multiple Integris system configurations, so technical specifications, detector size, table capacity and imaging capabilities may vary by model.
• Use requires trained personnel, appropriate infection-control procedures and routine inspection and preventive maintenance.