Interventional device developer BioSphere Medical has received the European CE Mark for transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using its HepaSphere microspheres.
As a condition of the approval, the Rockland, MA-based BioSphere will conduct a 100-patient postmarket study in 10 to 15 European centers.
Standard TACE is a two-stage process involving the injection of a concentrated dose of chemotherapeutic drugs, such as doxorubicin, directly into blood vessels supplying a tumor. An embolic agent then is infused through a catheter and into the blood vessels that feed a tumor to block its blood supply.
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