Medical Disclaimer

TheraSphere® is authorized by Federal Law (USA) for use as a humanitarian device in 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. 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. All relevant regulatory requirements for the study of an investigational device will be met in all countries in which the above-noted trials will be conducted. In particular, the STOP-HCC and EPOCH trials will be conducted under an Investigational Device Exemption (IDE) approved by the FDA, and will comply with all FDA and institutional review board requirements.