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Interventional device developer BioSphere Medical has received the European CE Mark for transarterial chemoembolisation (TACE) of hepatocellular carcinoma using its HepaSphere microspheres.
As a condition of the approval, the US-based company will conduct a 100-patient postmarket study in 10 to 15 European centres.
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 tumour.
An embolic agent then is infused through a catheter and into the blood vessels that feed a tumour to block its blood supply.
HepaSphere microspheres were launched in Europe in 2005.
The microspheres are sold by the firm’s direct sales force in France and through its network of distributors in the remaining countries of the EU.