Indications

 

Humanitarian Device

TheraSphere® is authorized by Federal Law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of this device for this use has not been demonstrated.

Indication

TheraSphere® is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.1

Common adverse effects include fatigue, pain, and nausea. The majority of adverse effects were mild to moderate in severity and were manageable or resolved over time. For details on rare or more severe adverse effects, please refer to the TheraSphere® Package Insert.1,3,5


Product may have different labelling in different countries. Federal (USA) law restricts this device to sale by or on the order of a physician with the appropriate training and experience.