Device Dossier

TheraSphere™ Yttrium-90 Glass Microspheres - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant

Device Dossier for TheraSphere™ Yttrium-90 Glass Microspheres - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant (Radionuclide…

Intended purpose

TheraSphere Microsphere is intended to treat liver tumors by local deposition of radioactive Yttrium-90 glass microspheres in the tumoral vasculature.

Functional description

TheraSphere is a low toxicity, targeted liver cancer therapy made of insoluble glass beads containing radioactive yttrium-90 (Y-90). The mean sphere diameter ranges from 15-35 micrometres with 22,000-73,000 microspheres per mg dose dispersed in pyrogen-free water. Y-90 is a pure beta emitter with an average tissue penetration of 2.5mm. Most of the radiation is delivered to the tumour in the first two weeks after treatment. Custom dose sizes are available in 0.5GBq increments between 3-20GBq.

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