Access Vascular Highlights New Bacterial Adhesion Study Data

Access Vascular Inc. (AVI) is sharing findings from a new, in-vitro study showing a significant reduction in bacterial adhesion and thrombus accumulation in peripherally inserted central catheters (PICC) and midline catheters with its MIMIX hydrophilic biomaterial (HBM).
 
Rates of central-line associated bloodstream infections (CLABSI) have risen as much as 51%ⁱ since the COVID-19 pandemic; a single CLABSI case can cost hospitals more than in $1 million in lost revenue,ⁱⁱ not including impacts on CMS reimbursement. Most importantly, CLABSI can lead to a myriad of patient complications, ranging from extended hospital stay to an increased risk of death.ⁱⁱⁱ
 
The study compared bacterial adhesion on two polyurethane-based catheters and the HBM using in-vitro blood flow and static models. The HBM demonstrated a 99.998% reduction in bacterial adhesion compared with the standard polyurethane catheter, and a 99.989% reduction compared with an augmented polyurethane material.
 
Additionally, the HBM catheter demonstrated a 96% reduction in surface thrombus accumulation, compared with the standard catheter, and a 95% reduction compared with the augmented polyurethane catheter. These findings are consistent with previously reported in-vitro data on thrombus accumulation, based on platelet count,^iv,v with the HBM catheter.
 
“These results highlight the potential for catheters made from MIMIX to reduce bacterial adhesion, which often leads to central-line associated bloodstream infections (CLABSI) and has devastating implications for already sick patients,” Access Vascular CEO James Biggins said. “We are pleased to share this data as the next step in establishing the true potential of MIMIX to improve the standard of care, take costs out of the healthcare system, and reduce the burden on nursing staff.”
 
 AVI also is sharing results from a separate study investigating the surface and frictional properties of the HydroPICC device. Published in the Journal of the Mechanical Behavior of Biomedical Materials, the study showed a statistically significant decrease in the maximum insertion, maximum retraction, and average force with HydroPICC compared with standard and augmented polyurethane catheters.^vi
 
 Access Vascular was founded to address intravenous therapy complications: infection, thrombosis, and phlebitis. Taking a foundationally different approach to thrombus reduction, the company manufactures intravenous catheters from a proprietary hydrophilic material. Engineered to mimic the body’s natural chemistry, Access Vascular catheters are designed to evade the foreign body response and the complications that come with it. Its U.S. Food and Drug Administration-cleared products are HydroPICC and HydroMID. 

References
ⁱ Fakih, M., et al. (2021). Infection Control Hospital Epidemiology, 1-6. doi:10.1017/ice.2021.70
ⁱⁱ Shepard, J. J of Infection Control; 48 (2020) 255−260.
ⁱⁱⁱ Siempos II, Kopterides P, Tsangaris I, Dimopoulou I, Armaganidis AE. Impact of catheter-related bloodstream infections on the mortality of critically ill patients: a meta-analysis. Crit Care Med 2009; 37:2283-9.
^iv Mannarino MM, Bassett M, Donahue DT, Biggins JF. Novel high-strength thromboresistant poly (vinyl alcohol)-based hydrogel for vascular access applications. Journal of Biomaterials Science, Polymer Edition. 2020 Mar 23;31(5):601-21. DOI: 10.1080/09205063.2019.1706148.
^v Data on file at Access Vascular. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. 
Pre-clinical in vitro/in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
^vi LeRoy, K. J., & Donahue, D. T. (2023). Trackability of a high strength thromboresistant hydrogel catheter: An In vitro analysis comparing venous catheter forces in a simulated use pathway. Journal of the Mechanical Behavior of Biomedical Materials, 1056070.