Surefire infusion system receives CE Mark approval

WESTMINSTER, CO, USA – Surefire Infusion System, a next generation device for chemo- and radioembolization procedures, has recently gained CE mark approval.

The company who developed the system, Surefire Medical, announced that it is launching the product in the European market immediately. The same device received FDA 510(k) clearance in the US in June 2011.

"Surefire Medical developed this ground-breaking technology to provide interventional radiologists with improved embolization certainty during their infusion procedures," said Jim Chomas, CEO of Surefire Medical. "With the CE Mark approval, we are able to introduce the Surefire Infusion System, which may offer substantial advantages over a standard microcatheter, throughout Europe."

A study of 29 patients showed that infusion of therapeutic agent with the Surefire Infusion System had no angiographic evidence of reflux and no clinical evidence of non-target embolization. CT imaging in chemoembolization patients suggested a pattern of increased microsphere tumor penetration and contrast retention.

Surefire Medical will participate in the upcoming annual meeting of the Cardiovascular and Interventional Radiological Society of Europe 2012 in Lisbon, Portugal, to launch the product.