Device Dossier

DC Bead M1™ Embolic Drug-Eluting Bead - Embolization particle, non-bioabsorbable

Device Dossier for DC Bead M1™ Embolic Drug-Eluting Bead - Embolization particle, non-bioabsorbable (Embolization particle, non-bioabsorbable, Class III,…

Intended purpose

DC Bead M1™ Embolic Drug-Eluting Bead is intended to embolize vessels of hypervascular tumors (HVTs) in the liver using interventional arterial administration. The beads are capable of loading doxorubicin or irinotecan drugs for chemoembolization.

Functional description

DC Bead M1™ Embolic Drug-Eluting Bead has 2 modes of action: • The primary mode is mechanical obstruction of the target vessel resulting in ischemia of the tissue. • The secondary mode of action is the ability to load a chemotherapeutic agent (doxorubicin or irinotecan) and to elute a local, controlled, and sustained dose of chemotherapeutic agent to the tumor after embolization.

TGA Public Summary