Contour Se Microspheres Syringe

FDA-Cleared Indications

• Embolization of blood vessels in the peripheral vasculature.
• Use as an embolic material during indicated interventional radiology procedures.
• The specific treated condition, vessel, microsphere size, and delivery technique must follow the device labeling and treating physician's judgment.

Clinical Applications

• Catheter-directed embolization of selected peripheral blood vessels.
• Uterine artery embolization for appropriately selected patients with symptomatic uterine fibroids, when consistent with the product labeling.
• Embolization of selected vascular lesions or bleeding vessels when the procedure is within the cleared labeling.
• Reduction of blood flow to a targeted vascular territory using image-guided catheter delivery.

Reported off-label uses

• Embolization of selected hypervascular tumors.
• Embolization of selected arteriovenous malformations.
• Embolization of other vascular bleeding or malformation sites not specifically listed in the cleared indication.

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

• Microsphere size should be selected for the target vessel, vascular anatomy, desired level of occlusion, and embolization objective.
• Delivery requires a compatible catheter and fluoroscopic or other appropriate imaging guidance; injection should be performed slowly and carefully to reduce the risk of nontarget embolization.
• Contraindications and precautions include uncorrectable coagulopathy, severe vasospasm, vessel anatomy that cannot safely accommodate the catheter, significant unresolvable arterial shunting, and known hypersensitivity to relevant materials or contrast media.
• MRI safety depends on the specific product labeling and the materials used; the device record alone should not be treated as confirmation that every component is MR Safe or MR Conditional.
• Embolization is generally intended to produce durable vessel occlusion, but recanalization, collateral blood flow, or disease progression may lead to recurrent symptoms or require additional treatment.