Westminster, Colo.-based Surefire Medical Inc. has been awarded the CE Mark to market its Surefire Infusion System, a chemotherapy and radioembolization device. Radioembolization is a cancer treatment that narrowly targets the tumor or affected area of the body with minimal impact on surrounding healthy tissue. The infusion system will be launched in Europe immediately.

“Surefire Medical developed this . . . 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.”

In a recent retrospective study of 29 patients, infusion of therapeutic agent with the Surefire Infusion System showed no angiographic evidence of reflux and no clinical evidence of non-target embolization. Computed tomography (CT) imaging in chemoembolization patients suggested a pattern of increased microsphere tumor penetration and contrast retention, the company reported.

Additionally, the Surefire High-Flow Microcatheter System recently received U.S. Food and Drug Administration 510(k) clearance. The Surefire Infusion System received 510(k) clearance in June 2011.

Surefire Medical Inc. was founded in 2009 to develop infusion systems for the interventional radiology and interventional oncology markets. Surefire’s infusion systems are designed to precisely deliver embolic agents through a microcatheter with an expandable tip that collapses in forward flow and dynamically expands to the vessel wall in reverse flow in order to increase embolization efficiency, minimize reflux and reduce damage to healthy tissue.

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