Device Dossier

DC Bead LUMI Radiopaque Embolic Drug-Eluting Bead - Embolization particle, non-bioabsorbable

Device Dossier for DC Bead LUMI Radiopaque Embolic Drug-Eluting Bead - Embolization particle, non-bioabsorbable (Embolization particle,…

Intended purpose

DC Bead LUMI Device is intended to embolize vessels of malignant hypervascular tumors (HVTs) in the liver using interventional arterial administration. DC Bead LUMI Device is capable of loading and eluting doxorubicin or irinotecan drugs for a local, controlled, and sustained release of the chemotherapeutic agent to the tumor after embolization.

Functional description

DC Bead LUMI is a hydrogel bead, which is radiopaque, biocompatible, hydrophilic, non-resorbable, size calibrated and capable of loading and eluting doxorubicin or irinotecan prior to embolization and then as a secondary action, elute a local, controlled and sustained dose to the tumour after embolization.

TGA Public Summary