HydroPearl Microspheres

FDA-Cleared Indications

• Embolization of the prostatic arteries for the treatment of symptomatic benign prostatic hyperplasia.

Clinical Applications

• Prostatic artery embolization for symptomatic benign prostatic hyperplasia.
• Selective embolization of prostatic arterial branches supplying the enlarged prostate.

Reported off-label uses

• Uterine artery embolization for symptomatic uterine fibroids.
• Genicular artery embolization for selected patients with knee osteoarthritis-related pain.
• Other embolization procedures in which calibrated microspheres are used to reduce blood flow, when selected by a treating specialist.

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

• HydroPearl Microspheres are polyethylene glycol-based embolic microspheres supplied in calibrated particle sizes; the appropriate size depends on the target vessel and treatment goal.
• They are delivered through a catheter under fluoroscopic or other image guidance, commonly through femoral or radial arterial access depending on the procedure.
• The product should not be injected into non-target arteries or vessels supplying the brain, spinal cord, or other critical organs; careful angiography is required to identify dangerous anastomoses.
• Compatibility with the delivery catheter, contrast medium, and injection technique should be confirmed in the current manufacturer instructions for use.
• MRI safety and conditional-use information depends on the labeled product configuration and should be checked in the current instructions for use; retained microspheres are intended to remain in the treated vessels.