Trufill PVA Particles

FDA-Cleared Indications

• Embolization of hypervascular tumors.
• Embolization of arteriovenous malformations.

Clinical Applications

• Catheter-based embolization of selected hypervascular tumors.
• Catheter-based embolization of selected arteriovenous malformations.
• Preoperative or therapeutic reduction of blood flow to a labeled hypervascular lesion.
• Selective embolization performed by interventional radiology or neurointerventional specialists when the target anatomy is appropriate.

Reported off-label uses

• Uterine artery embolization for symptomatic uterine fibroids.
• Embolization of selected bleeding arteries.
• Embolization of vascular malformations or tumors in clinical situations not specifically 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

• Particles are available in different size ranges; the treating specialist selects the size according to the target vessel, lesion, blood-flow pattern and desired level of occlusion.
• The particles are delivered through a compatible embolization catheter under fluoroscopic or other image guidance. Careful injection technique is needed to reduce reflux and unintended embolization.
• Contraindications and precautions include allergy to device materials or contrast media, unsuitable vascular anatomy, non-target blood flow and inability to safely catheterize the target vessel.
• The particles are intended to produce permanent or durable vessel occlusion, although recanalization or development of collateral blood flow can occur.
• MRI safety should be confirmed from the current product labeling and implant documentation. The particles themselves are not metallic, but the complete procedure and any other implanted materials should be reviewed before MRI.