HepaSphere™ Microspheres (Outside US Only)

Predictable

Retains spherical shape with consistent cross sectional diameter after reconstitution with aqueous-based solutions, such as contrast media and 0.9% saline solution, for predictable flow-directed level of occlusion in the vasculature.

Conformable

Affords atraumatic conformability to the architecture of the vessel lumen, providing more contact surface area with the embolic material and the vessel intima, leading to a more complete occlusion of the vessel.

Illustration of HepaSphere Microspheres conforming to the architecture of the vessel lumen.

Loadable

• Entire microsphere loads and absorbs drug
• Sustained drug delivery(1)
• Homogenous drug dispersion

(1)data on file

When in contact with non-ionic contrast media or normal saline (NaCI 0.9%) before delivery, HepaSphere Microspheres expand to approximately 4x their dry state diameter. HepaSphere Microspheres are calibrated, spherical, hydrophilic microspheres made from 2 monomers (vinyl acetate and methyl acrylate) that combine to form a copolymer (sodium acrylate alcohol copolymer). This proprietary design allows a more complete and targeted occlusion of the blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures:

• Embolization of hepatocellular carcinoma

• Embolization of metastases to the liver

HepaSphere Microspheres’ unique properties offer the following advantages:

• Targeted: Flow directed due to spherical shape.

• Absorbing: Rapidly absorbs aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI*.

• Conforming: Compresses in the vessel lumen, providing more surface contact with vessel intima.

• Expanding: Expands up to four times the stated dry diameter when hydrated.

* Doxorubicin HCl used with HepaSphere Microspheres should be reconstituted with saline, never use pure water.

Regulatory Information

USA

HepaSphere Microspheres are not approved or available for sale in the United States.

Canada

HepaSphere Microspheres without doxorubicin HCl loaded (bland) are indicated for use in embolization of blood vessels for therapeutic or preoperative purposes in the following procedures:

• Embolization of hepatocellular carcinoma

• Embolization of metastases to the liver

HepaSphere Microspheres loaded with doxorubicin HCl are indicated for use in embolization of blood vessels for therapeutic or preoperative purposes in:

• Embolization of unresectable hepatocellular carcinoma

European Union

HepaSphere Microspheres are indicated for use in embolization of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures:

• Embolization of hepatocellular carcinoma

• Embolization of metastases to the liver

For all other locations, please contact your local Merit Medical representative.

For full prescribing information please refer to the HepaSphere Microspheres Instructions for Use.