Bioset Xc

FDA-Cleared Indications

• Use in embolization procedures to occlude or reduce blood flow through targeted blood vessels.
• Use when selective vascular occlusion is needed to treat a patient’s diagnosed condition, as specified in the device labeling.

Clinical Applications

• Catheter-based embolization of selected abnormal blood vessels.
• Embolization of vascular lesions or malformations when vascular occlusion is clinically indicated.
• Selective reduction of blood flow to a targeted tissue region under imaging guidance.

Reported off-label uses

• Use of embolic microspheres for transarterial treatment of hypervascular tumors may be reported in clinical practice, but the specific indication should be confirmed against the device’s current labeling.
• Use in uterine fibroid embolization may be reported for embolic microsphere devices, but it should not be assumed to be an FDA-cleared indication for this specific product without reviewing its 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 operator must select the particle size and injection technique according to the target vessel size, blood-flow pattern, anatomy and intended degree of occlusion.
• Delivery requires a compatible catheter system and fluoroscopic or other appropriate imaging guidance; device compatibility should be confirmed before use.
• Avoid unintended embolization by assessing collateral vessels, arteriovenous shunting and flow direction before injection.
• Contraindications, warnings, handling instructions and MRI status should be checked in the current manufacturer labeling and instructions for use; the available FDA summary does not establish MRI safety.
• Embolization is permanent or long-lasting for the treated vascular bed, although recanalization, collateral blood flow or disease progression can occur.