SAN CLEMENTE, California, April 23, 2014 – ICU Medical, Inc. (NASDAQ: ICUI) today announced that a new peer-reviewed study in the April 2014 issue of the International Journal of Nephrology and Renovascular Disease shows that the use of the company’s Tego® needlefree connector on hemodialysis catheters is associated with a 10-12% reduction of catheter-related bloodstream infections (CRBSI). The study also associated the use of Tego with a reduction in missed dialysis treatments as well as the use and cost of thrombolytics, antibiotics and erythropoiesis-stimulating agents (ESAs), “which could have a substantive financial impact for dialysis providers, particularly in the light of the recent rebasing of Centers for Medicare and Medicaid Services reimbursement rates for dialysis,” according to the researchers.
The study performed by Steven Brunelli, MD, MSCE et al for DaVita® Clinical Research (DCR) is a retrospective analysis comparing outcomes among DaVita patients receiving in-center hemodialysis using a central venous catheter with either the Tego connector or standard catheter caps. Incidence rates for intravenous antibiotic starts, receipt of an IV antibiotic course, positive blood cultures, mortality, missed dialysis treatments, utilization of erythropoiesis-stimulating agents (ESAs), and thrombolytics were calculated and compared. The analysis comprised 10,652 Tego patients and 6,493 non-Tego patients (controls).
As the first large-scale study on the impact of Tego connectors on CRBSI, this study improves on results from previous smaller studies in showing a reduced infection rate along with reduced utilization of ESA.
Dr. Brunelli and team used three metrics to identify CRBSI: the receipt of any IV antibiotic, administration of two or more doses of antibiotics within a 21-day period, and the occurrence of a positive blood culture. In this retrospective analysis, the Tego connector use was found to be independently associated with a 10-12% reduction in risk of CRBSI, as defined by initiation of IV antibiotics or initiation of an IV antibiotic course.
Additionally, the Tego population experienced lower levels of ESA utilization and dosage, reducing pharmaceutical costs and challenging the idea that the saline lock possible with Tego could fail to control catheter occlusions as well as a heparin lock. The researchers said, “one plausible hypothesis is that ESA requirements might be lower among Tego patients by virtue of lower catheter infection/colonization burden.”
The Tego connector is world’s first and only needlefree connector FDA-cleared for use in hemodialysis applications. Specifically designed for use in hemodialysis, the Tego needlefree connector allows for significantly less catheter hub manipulation and minimizes the risk of catheter contamination and CRBSIs. Reducing CRBSIs can reduce complications for patients and avoid costly scheduling disruptions for dialysis clinics.