CorMedix Inc. CRMD today announced that it has received CE Mark
approval for Neutrolin®, a catheter lock solution, for patients with central
venous catheters on hemodialysis secondary to advanced chronic kidney disease.
The Neutrolin solution includes an anti-coagulant and broad-spectrum
antimicrobial (antibacterial and antifungal) combination that is active
against common microbes including antibiotic-resistant strains, and in
addition, inhibits the formation of biofilm. Neutrolin, as a catheter lock
solution, has been proven to significantly reduce the incidence of catheter
related bloodstream infections (CRBIs) as well as maintain catheter patency by
inhibiting thrombosis, thus reducing the need for systemic antibiotics and
prolonging central venous catheter life.
CorMedix received the CE Mark for Neutrolin as a Class III device, which
allows the company the ability to market and sell the catheter lock solution
in European Union (EU) member countries that have adopted the Medical Devices
Directive (MDD) without being subject to additional national regulations with
regard to demonstration of performance and safety (although certain EU member
countries may request or require additional performance and/or safety data on
a case-by-case basis). The CE mark also permits the sale of Neutrolin in
countries that have an MDD Mutual Recognition Agreement with the EU.
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