Surefire Medical, a developer of infusion systems, has received CE mark approval for its new Surefire infusion system, designed for use in chemo and radioembolization procedures.
The CE mark approval is based on a recent retrospective study of 29 patients, which showed that infusion of therapeutic agents with the Surefire Infusion system has no angiographic evidence of reflux and no clinical evidence of non-target embolization.
Patients also evidenced a pattern of increased microsphere tumor penetration and contrast retention on CT imaging in chemoembolization.
Surefire Medical CEO Jim Chomas said the company developed the technology to provide interventional radiologists with improved embolization certainty during their infusion procedures.
"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," Chomas added.
The company said the Surefire system has also received FDA 510(k) clearance in June 2011.