CorMedix gains CE mark for Neutrolin catheter lock solution
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By: Katie Bell
Ref: Business Wire, StreetInsider
Published: 07/05/2013
CorMedix announced Friday that it received CE mark approval for the catheter lock solution Neutrolin for patients with central venous catheters on haemodialysis secondary to advanced chronic kidney disease. The device, which includes an anti-coagulant and broad-spectrum antimicrobial combination, "significantly [reduces] the incidence of catheter-related bloodstream infections, [and maintains] catheter patency by inhibiting thrombosis, reducing the need for systemic antibiotics and prolonging central venous catheter life," the company noted.
Neutrolin will initially be launched in Germany and Austria, and CorMedix said it is in discussions with potential partners to market the product elsewhere in Europe, as well as the Middle East and Asia. In the long term, the company hopes to expand use of the device to include oncology patients requiring catheters, in addition to other indications.
CorMedix also said it is "now poised to pursue a regulatory strategy for approval of Neutrolin" in the US.
Neutrolin will initially be launched in Germany and Austria, and CorMedix said it is in discussions with potential partners to market the product elsewhere in Europe, as well as the Middle East and Asia. In the long term, the company hopes to expand use of the device to include oncology patients requiring catheters, in addition to other indications.
CorMedix also said it is "now poised to pursue a regulatory strategy for approval of Neutrolin" in the US.