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news.PLC Systems has received the CE Mark Certificate for its RenalGuard System, clearing the way for the company to begin its initial launch of the product in the EU.
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The company expects to initiate a limited launch of RenalGuard in the first quarter of 2008 in Italy, targeting early adoptors who recognize the benefits of utilizing the unique fluid balancing capabilities of the RenalGuard System in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of Contrast-Induced Nephropathy (CIN).
Having secured CE Mark approval for RenalGuard, PLC expects to conclude negotiations with an Italian distribution partner shortly. Finalization of a distribution agreement is expected to include an initial stocking order of product from the distributor to support the initial sales launch of RenalGuard at select hospital sites throughout Italy.
Mark Tauscher, president and CEO of PLC, said: “Our initial launch in Italy will be supported by the previously announced planned clinical trial at the Centro Cardiologico Monzino (CCM-University of Milan) in Milan, Italy.”