CorMedix Receives CE Mark for Neutrolin Catheter Lock Solution Wall Street Journal (07/05/13)
CorMedix Inc. has received CE Mark approval for Neutrolin, a catheter lock solution developed for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease. The solution features an anticoagulant and broad-spectrum antimicrobial combination that is effective against common microbes, even antibiotic-resistant strains, and the formation of biofilm. Neutrolin has been proven to significantly reduce the incidence of catheter-related bloodstream infections and to maintain catheter patency by preventing thrombosis. The CE Mark identifies Neutrolin as an approved Class III device, which can be marketed and sold in all European Union (EU) member countries that have adopted the Medical Devices Directive (MDD) without being subject to additional national regulations. It also can be sold in nations that have an MDD Mutual Recognition Agreement with the EU. Neutrolin will initially be launched in Austria and Germany by CorMedix Europe GmbH, and the company is currently in discussions with potential partner companies to market in Asia, Europe, and the Middle East. In addition, the company is preparing to pursue a regulatory strategy for approval of Neutrolin in the United States and expand the device's use to oncology patients.
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Sure wish this piece contained information about what this solution actually is generically. I tried to do a Google search but nothing comes up. Thanks for posting, Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
www.biospace.com/News/cormedix-reports-receipt-of-european-patent-office/307776
register.epo.org/application
www.google.com/patents/US7696182
www.cormedix.com/news_pr.php
Peter Marino R.N. BSN CRNI VA-BC Hospital based staff R.N. with no affiliation to any product or health care company.