HydroPearl Microspheres HydroPearl Microspheres

FDA-Cleared Indications

• Embolization of selected blood vessels when temporary or permanent vascular occlusion is clinically indicated.
• Use in interventional procedures requiring embolic material to promote vascular occlusion.

Clinical Applications

• Embolization of hypervascular tumors or other abnormal vascular territories when consistent with the device labeling and particle-size selection.
• Uterine artery embolization for symptomatic uterine fibroids when the procedure and device selection are appropriate.
• Prostatic artery embolization for selected patients with benign prostatic hyperplasia when consistent with applicable labeling and clinical practice.

Reported off-label uses

• Genicular artery embolization for selected patients with knee osteoarthritis has been described in clinical practice and research, but this use may be outside the device's specific FDA-cleared labeling.
• Embolization of selected abnormal peripheral vascular beds for bleeding or other indications may be performed off label depending on the anatomy, indication, and institutional practice.

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

• Particle sizes must be selected according to the target vessel, flow rate, vascular anatomy, and desired level of occlusion. Smaller particles can travel more distally and may increase the risk of nontarget embolization.
• The microspheres are delivered through a compatible catheter or microcatheter under fluoroscopic or other appropriate imaging guidance. Operators should follow the device instructions for preparation, suspension, mixing, and delivery.
• HydroPearl Microspheres are intended to produce vascular occlusion; the duration of occlusion depends on the clinical situation, vessel, particle selection, and tissue response.
• Contraindications and precautions include known hypersensitivity to device components, vessels that cannot be safely catheterized, uncorrected coagulopathy, and significant risk of reflux or nontarget embolization. Patient-specific risks should be assessed before treatment.
• MRI safety should be confirmed from the current manufacturer labeling. The microspheres themselves are nonmetallic, but MRI considerations can differ when other devices, coils, stents, or embolic materials are also present.