January 6, 2020
Neutrolin has CE mark approval for use in the European Union for hemodialysis using a tunneled central vein catheter and use in oncology patients receiving chemotherapy, hydration and medications via central venous catheters. The CE Marking also covers patients receiving medication and fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). Neutrolin also has CE Marking for total parenteral, or IV, nutrition. For more information about Neutrolin and availability in the European Union, visit CorMedix Europe.
In Europe, a post-market clinical utility study evaluated the use of Neutrolin in the prevention of catheter-related blood infections (CRBSIs) and thrombosis. Under the study, 202 hemodialysis patients at 20 hemodialysis centers in Germany were enrolled in the ongoing Neutrolin Use Monitoring Program (NUMP), representing 15,464 dialysis sessions over a 26-month period, for a total of 36,083 hemodialysis catheter days. These data demonstrated that use of Neutrolin is associated with 96.0% reduction in the rate of CRBSI and 96.7% reduction in thrombosis compared to published historical benchmarks of 3.5 CRBSIs and 2-3 episodes of thrombosis per 1,000 catheter days. No significant adverse drug reactions that led to the discontinuation of Neutrolin use were reported. Real world data from the Neutrolin Use Monitoring Program also indicated that Neutrolin:
- Helps prevent inflammatory complications, which are a primary cause of morbidity among end-stage renal disease hemodialysis patients
- Reduces the need for local and systemic antibiotics, which can increase microbial resistance and infection risks
- Reduces the likelihood of catheter failures
- Prolongs catheter life, thus reducing the need for reinsertion procedures
- Reduces hospital lengths of stays