Malagari Safety and Efficacy Study of HCC TACE with HepaSphere™ Microspheres 30-60µm

Malagari photo of doc

Dr. Katerina Malagari et al conducted a study of 45 patients with hepatocellular carcinoma (HCC) treated with the new 30-60 µm size HepaSphere Microspheres. The study found that “TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality.”1 The overall objective response from the study was “(CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9% of cases.”1 The results were published in Cardiovascular Interventional Radiology in February 2014.

HepaSphere 30–60 µm is a new size of a loadable microsphere that has a dry caliber of 30–60 µm that expands to 166–242 (197 ± 31) µm in saline and 145–213 (148 ± 45) µm after loading with doxorubicin. 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.

HepaSphere Microspheres are indicated for use in embolisation of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures: Embolisation of hepatocellular carcinoma and embolisation of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.

Antonio Rivera
Senior Product Manager
1 Malagari K, Pomoni M, Moschouris H, Kelekis A, et al. Chemoembolization of hepatocellular carcinoma with Hepasphere 30-60 . Safety and efficacy study. Cardiovasc Intervent Radiol. 2014 Feb;37:165-175.

HepaSphere Microspheres is a Class III Device, CE 0459, and manufactured for Merit Medical Systems, Inc. by Biosphere Medical, S.A., Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile, 95700 Roissy en France. HepaSphere Microspheres are not approved or available for sale in the United States.