CorMedix Inc. has gained CE Mark approval for Neutrolin®, a catheter lock solution for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease.
Patients undergoing hemodialysis require access to the vascular system in order to perform treatments on a multiple scheduled basis each week. One of the major complications in the use of a central venous catheter for hemodialysis treatment is catheter-related bloodstream infections (CRBIs) and the inflammatory complications associated with them.
Neutrolin® is a catheter lock solution for the prevention of CRBI and maintenance of catheter patency in hemodialysis patients. It includes an anti-coagulant and broad-spectrum antimicrobial combination that is active against common microbes including antibiotic-resistant strains, and in addition, inhibits the formation of biofilm.
CorMedix Europe GmbH will launch Neutrolin in Germany and Austria initially. The company is in discussions with potential partner companies to market in Europe, the Middle East and Asia. Neutrolin is indicated for use in hemodialysis (HD) patients and the company has longer term goals to expand its use in oncology patients requiring catheters as well as in additional indications. CorMedix is also now poised to pursue a regulatory strategy for approval of Neutrolin in the United States.
“Receipt of the CE mark for Neutrolin as a Class III device is a significant accomplishment for CorMedix, as this registration required rigorous regulatory review against high clinical and manufacturing standards,” said Randy Milby, CorMedix’s Chief Executive Officer. “We are well prepared to make this important medical device available to patients with central venous catheters on hemodialysis. We look forward to Neutrolin being widely available in Europe with commercialization efforts led by national sales manager Joachim Petrak and his team at CorMedix Europe GmbH.”
Source: CorMedix, Inc., Business Wire