FDAnews
www.fdanews.com/articles/171133-surefire-medical-gets-ce-mark-for-infusion-systems-for-embolization-procedures

Surefire Medical Gets CE Mark for Infusion Systems for Embolization Procedures

May 8, 2015

Surefire Medical has received a CE mark for its new Precision targeted delivery infusion system for direct-to-tumor embolization procedures, the Westminster, Colo., devicemaker said Friday.

The product has improved trackability, and clinical evidence shows that greater drug penetration into tumors can bridge patients to a liver transplant or extend life by suppressing tumor growth, says President and CEO James Chomas.

Surefire infusion systems are used primarily in treating inoperable liver cancers, although clinical trials are under way for additional medical conditions, the company says.

Liver cancer is the third most common cause of cancer deaths worldwide, with 2.2 million cases. In the U.S., the liver cancer rate doubled between 1981 and 2010, according to the Centers for Disease Control and Prevention. — Kellen Owings