📊 Evidence-Based Reference

TheraSphere

Product: TheraSphere — all models and sizes

Summary: TheraSphere is a device used for selective internal radiation therapy in patients with unresectable hepatocellular carcinoma. Key evidence highlights its use in improving local tumor control.

FDA Clearance Information

Pathway ? PMA

Number ? P200029 ↗

Decision Date ? March 17, 2021

Product Code ? NAW Microspheres Radionuclide

Device Class ? Class 3

Evidence ? 14 studies

TheraSphere received FDA premarket approval (PMA) on March 17, 2021. Manufactured by Boston Scientific, it is classified as a Class 3 device.

What It Is

TheraSphere is a medical device that delivers yttrium-90 glass microspheres for selective internal radiation therapy. It is intended for local tumor control in patients with unresectable hepatocellular carcinoma.

FDA-Cleared Indications

Selective internal radiation therapy for local tumor control of solitary hepatocellular carcinoma tumors measuring 1 to 8 cm in diameter.
Use in patients with unresectable hepatocellular carcinoma who have Child-Pugh Score A cirrhosis and well-compensated liver function.
Use in patients without macrovascular invasion and with good performance status.

Clinical Applications

Y-90 radioembolization for a solitary, unresectable hepatocellular carcinoma tumor measuring 1 to 8 cm.
Selective delivery of yttrium-90 glass microspheres through the hepatic arterial circulation to treat liver tumor tissue.
Local tumor control in appropriately selected patients with Child-Pugh A cirrhosis and preserved liver function.
Treatment planning and administration by an experienced multidisciplinary liver tumor team.

Reported off-label uses

Treatment of other primary liver tumors, including selected intrahepatic cholangiocarcinoma cases.
Treatment of liver-dominant metastatic tumors, such as colorectal or neuroendocrine cancer metastases.
Treatment of hepatocellular carcinoma with tumor characteristics or liver function outside the specific FDA-labeled population.

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.

Evidence Summary

The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. The studies span from 2022 to 2025, focusing on the efficacy and safety of TheraSphere.

Reported Outcomes

Published studies report that TheraSphere is effective in improving local tumor control in hepatocellular carcinoma. It has been shown to be beneficial in combination with chemotherapy for certain liver cancers. Cost-effectiveness analyses suggest personalized dosimetry may enhance outcomes.

Safety Profile

Reported complications include potential radiation-induced liver disease and other liver-related adverse events. However, the overall safety profile is considered acceptable within the studied patient populations.

Evidence Limitations

The evidence is limited by the lack of large-scale randomized controlled trials directly comparing TheraSphere to other treatment modalities. Further research is needed to explore long-term outcomes and optimal dosimetry strategies.

Practical Considerations

The FDA indication specifies a solitary tumor measuring 1 to 8 cm; patient selection also includes Child-Pugh A cirrhosis, well-compensated liver function, no macrovascular invasion and good performance status.
Treatment requires hepatic arterial mapping, assessment for vessels that could carry microspheres to the stomach or intestine, and usually a planning study before administration.
The microspheres are delivered through a catheter placed in a hepatic artery, typically using fluoroscopic and angiographic guidance with local anesthesia and moderate sedation.
TheraSphere contains radioactive yttrium-90 and requires specialized preparation, handling, radiation-safety procedures and treatment planning; it is not a permanent implant intended to remain radioactive indefinitely.
MRI compatibility and scan conditions should be confirmed with the current product labeling and the treating facility because the complete treatment system includes delivery components and radioactive material.

Procedures that use this device

Y-90 Radioembolization (SIRT)