Surefire Medical’s Infusion System for Embolization Procedures Receives CE Mark Approval
Company to launch immediately in the European market WESTMINSTER, Colo., USA (Sept. 5, 2012) – European regulators have approved Surefire Medical’s Surefire Infusion System, a next generation device for chemo- and radioembolization procedures. The Colorado-based medical device company today announced that it is launching this product in the European market immediately.
“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.”
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 nontarget embolization. CT imaging in chemoembolization patients suggested a pattern of increased microsphere tumor penetration and contrast retention.1
Additionally, the next generation Surefire Infusion System ST/LT recently received U.S. FDA 510(k) clearance. The Surefire Infusion System received FDA 510(k) clearance in June 2011.
As part of the international launch, Surefire Medical will participate in the upcoming annual meeting of the Cardiovascular and Interventional Radiological Society of Europe 2012 in Lisbon, Portugal.
1 J. D. Louie, E. A. Wang, S. Broadwell, B. C. Wible, A. Arepally, C. Nutting, L. Bester, D. Y. Sze. First in Man Experience with the Surefire Infusion System – A dedicated microcatheter system to eliminate reflux during embolotherapy. Presented during Society of Interventional Radiology Annual Scientific Meeting, March 2012.