Device Dossier

Embozene TANDEM Microspheres - Embolization particle, non-bioabsorbable

Device Dossier for Embozene TANDEM Microspheres - Embolization particle, non-bioabsorbable (Embolization particle, non-bioabsorbable, Class III, sponsor…

Intended purpose

Embozene TANDEM Microspheres are a non-bioabsorbable, implantable bead/microsphere intended for embolization of blood vessels supplying primary hypervascular tumors or metastases in the liver.

Functional description

Embozene TANDEM Microspheres are embolic microspheres with a primary mode of action to permanently occlude blood vessels. TANDEM Microspheres are compatible with doxorubicin or irinotecan which can be loaded prior to embolisation and, as a secondary mode of action, will elutethe drug to the tumour in a control dose after embolisation.

TGA Public Summary