Pursuit Vascular announced that a clinical study, in collaboration with Fresenius Medical Care and Frenova Renal Research, found a statistically significant reduction in both bloodstream infection and hospitalization due to infection when ClearGuard HD Antimicrobial Barrier Caps were utilized for patients receiving dialysis treatment via central venous catheters (CVCs
The 12-month, prospective, multi-center randomized clinical study was conducted at 40 Fresenius Medical Care clinics in the U.S. The goal of the study was to assess the impact to bloodstream infection rates (represented by positive blood cultures (PBCs)) and hospitalization due to infection resulting from use of ClearGuard HD Antimicrobial Barrier Caps as compared to conventional caps, the current standard of care.
Results from a planned interim analysis of data collected after 9-months of usage in more than 2,000 patients and over 250,000 CVC-days demonstrated ClearGuard HD Antimicrobial Barrier Caps decreased the incidence of PBCs by 73% (p < 0.001) during the third quarter of the study, decreased the overall incidence of PBCs in de novo catheters by 76% (p = 0.020) and reduced the overall incidence of hospitalization due to infection by 37% (p = 0.019). Final results are expected to be published in 2016.
"These are significant results and document an important potential benefit to patient health while receiving positive feedback from our staff about the ease of use," said principal investigator Jeffrey Hymes, M.D., Chief Medical Officer at Fresenius Medical Services.
Despite infection-control protocols and quality clinical care, the prevalence of CVCs for hemodialysis remains high, predisposing patients to costly and potentially deadly bloodstream infections. With this initial study in the hemodialysis market, Pursuit Vascular believes its patented ClearGuard technology platform could play an important role in reducing infections and keeping patients out of the hospital, which are all critical drivers as we enter an era of value-based care.
"These clinical results represent a historic milestone in our effort to commercialize in the U.S., and we appreciate the dedication Fresenius Medical Care has shown to improving patient care by engaging in the study," said Doug Killion, President and CEO of Pursuit Vascular. "
The ClearGuard HD Antimicrobial Barrier Cap is the first and only device cleared for sale in the U.S. that kills infection-causing bacteria inside a long-term hemodialysis catheter. This simple yet revolutionary single-use device triggered the creation of a new Product Code (PEH) by the Food and Drug Administration (FDA) "for use in hemodialysis catheters to reduce hub infection".