Neutrolin® and biofilm formation

Heparin 7 months
Neutrolin® 5 months

Figure 1 shows two scanning electron microscope (SEM) photos of the luminal surfaces from two different catheters. The left catheter was removed from the HD patient who had been using a conventional heparin lock for 7 months. The photo on the right of an HD patient using Neutrolin* locked catheter has no evidence of any biofilm after 5 months in vivo.4

Validated Clinical Utility in “EU Real World” Setting – Neutrolin® Usage Monitoring Program (NUMP)

  • From January 2014 to November 2015, 19 hemodialysis centers in Germany participated in  Neutrolin® Usage Monitoring Program
  • 199 HD patients representing 15,122 dialysis sessions over a 22 months period for a total of  35,285 hemodialysis catheter days
  • 5 infections and 3 thrombosis events over the 35,285 hemodialysis catheter days
  • The primary outcome of our study is to monitor safety and efficacy of Neutrolin® in preventing  infection and thrombosis in HD patients
Complication (per 1,000 catheter days) Historical Benchmark Neutrolin® % Reduction in Infection Rate
Infection
Thrombosis
3.5
2–3
0.142
0.085
96.0 %
96.6 %

Positive results are consistent with prior clinical studies

1) CDC Guidelines for the Prevention of Intravascular Catheter Related Infections; 2) O`Grady et al., 2011; Morris P, Knechtle SJ. Kidney Transplantation - Principles and Practice. Saunders, 2013. 3) Napalkov P, Felici DM, Chu LK, Jacobs JR, Begelman SM. Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis. BMC Cardiovasc Disord. 2013 Oct 16;13:86. doi: 10.1186/1471-2261-13-86. PubMed PMID: 24131509; PubMed Central PMCID: PMC4015481 4) Quarello F, Forneris G. Prevention of hemodialysis catheter-related bloodstream infection using an antimicrobial lock. Blood Purif. 2002;20(1): 87-92. Review. PubMed PMID: 11803164. 5) Napalkov P, Felici DM, Chu LK, Jacobs JR, Begelman SM. Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis. BMC Cardiovasc Disord. 2013 Oct 16;13:86. doi: 10.1186/1471-2261-13-86. PubMed PMID: 24131509; PubMed Central PMCID: PMC4015481