US-based CorMedix has gained CE Mark clearance for its Neutrolin, a catheter lock solution that has been designed to prevent catheter related bloodstream infections (CRBI) in hemodialysis patients.
Classified as a Class III device, Neutrolin comprises an anti-coagulant and broad-spectrum of antibacterial and antifungal combination, which is active against microbes of common nature and restricts biofilm formation.
It helps in maintaining catheter patency by restricting thrombosis, thereby lessening the requirement for systemic antibiotics and extending the life of central venous catheters.
CRBIs and inflammatory complications are considered to be main reasons of morbidity in final stage renal disease hemodialysis patients.
Following the CE Mark, the company can now market the catheter lock solution in the EU.
CorMedix CEO Randy Milby said that the receipt of the CE mark for Neutrolin as a Class III device is a significant accomplishment for the company as this registration required regulatory review against high clinical and manufacturing standards.
"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 commercialisation efforts led by national sales manager Joachim Petrak and his team at CorMedix Europe GmbH," Milby added.
CorMedix Europe is planning to initially launch the device in Germany and Austria and plans to identify potential partners to sell the product in several markets of Europe, the Middle East and Asia.
The company intends to widen the use of the device in oncology patients who are in need of catheters.
In May 2013, the company received funds from two longtime investors Elliott Management and Kingsbrook Partners to support the commercialisation of the catheter lock solution.