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US Device Guide / Selective Internal Radiation Therapy

Company Name Product Name Material Radioactive Isotope Microsphere Diameter (µm) Specific Gravity (g/mL) Microspheres Per Vial (million) Activity per Vile (GBq) US FDA Indicated Use
Sirtex Medical Inc. SIR-Spheres Y-90 Resin Microspheres Resin Y-90 95% within 24–36 1.1 40–80 3 ± 10% Indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy of floxuridine
Boston Scientific Corporation TheraSphere Y-90 Glass Microspheres Glass Y-90 (integral to the glass matrix) 25 ± 10 3.3 Approximately 0.4 million per GBq at calibration (3 GBq vial contains approximately 1.2 million microspheres) Standard dose sizes: 3, 5, 7, 10, 15, 20; custom dose sizes: available in 0.5 increments, between 3–20 (activity/microsphere at calibration is 2,500 Bq) Indicated for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma who can have placement of appropriately positioned hepatic arterial catheters; also indicated for hepatocellular carcinoma patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment

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