BioSphere nets CE Mark OK

AuntMinnie.com staff writers
Dec 17, 2007

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.

Related Reading

BioSphere gets FDA nod for QuadraSphere, November 9, 2006

BioSphere launches HepaSphere in Europe, September 23, 2005

Use of gold loses luster in UAE, May 23, 2004

BioSphere gets FDA clearance for UFE microspheres, November 27, 2002

BioSphere uterine fibroid embolization device comparable to hysterectomy in study, April 9, 2002

Copyright © 2007 AuntMinnie.com

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