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www.fdanews.com/articles/68863-flowmedica-s-benephit-infusion-system-receives-ce-marking

FlowMedica's Benephit Infusion System Receives CE Marking

February 17, 2005

FlowMedica's Benephit Infusion System, a new device designed to deliver medications and other therapeutic agents directly to the kidneys, has received CE Marking, enabling FlowMedica to make the Benephit system available to physicians in all member countries of the European Union.

FlowMedica, a medical device company developing minimally invasive intravascular systems to treat kidney dysfunction related to certain interventional or surgical procedures and diseases, also announced the selection of the first of its European distributors, N.G.C. Medical of Italy. N.G.C. is a leading distributor of medical devices that focuses on innovative products in the cardiology field.

The Benephit Infusion System is an FDA-510(k)-cleared novel, proprietary selective infusion catheter system that delivers medications and other therapeutic agents directly to the kidneys through the renal arteries, a method called targeted renal therapy (TRT). TRT is an alternative to the standard delivery method of systemic intravenous infusion of medications to treat kidney dysfunction related to cardiovascular disease.