Polyflux ® Revaclear Dialyzers: The Next Generation in High-Flux Dialyzers

Background Membrane based medical therapies have increased considerably in recent years. However, very few changes have focused on the structure and components of the dialyzer. Consequently, the “current high flux dialyzers” are very much the same as they were 20 years ago. The need for more efficient dialyzers is clear. The necessity to mass produce these new dialyzers at a low cost has also placed demands on any membrane used in medical applications today. These demands are for specific transport characteristics, high clearances, blood compatibility and a design that enables a costefficient and reliable method of production. Objective To assess performance, thrombogenicity, blood and dialysate flow characteristics and ease of use, an in vitro and in vivo study program was conducted with the Polyflux Revaclear and Polyflux Revaclear MAX dialyzers —next-generation high-flux dialyzers with advanced membrane composition and design characteristics. Results The Polyflux Revaclear dialyzers (1.4 m² and 1.8 m² membrane area) demonstrated efficient removal of urea comparable to that of Fresenius Optiflux F160NR (1.5 m² membrane area) and F200NR (2.0 m² membrane area) dialyzers, with less blood-contacting membrane surface area; increased β 2 -microglobulin clearance relative to Optiflux dialyzers; lower thrombogenicitythan the Optiflux dialyzers; superior blood and dialysate flow characteristics and dynamics; and high ease of use. Clinical studies also showed limited influence of dialysate flow rates > 500 mL/min on performance of the Polyflux Revaclear dialyzers, suggesting that further investigation may demonstrate the potential for improved economics with respect to dialysate use. Conclusions In the studies, the Polyflux Revaclear and the Polyflux Revaclear MAX dialyzers demonstrated efficient removal of urea, superior β 2 -microglobulin clearance and lower thrombogenicityin comparison to Optiflux 160NR and 200NR dialyzers. It is believed these improved results are due to the relation of the membrane structure to transport properties, suggesting the deciding factors are pore radius, tortuosity, diffusion coefficients, pore shape uniformity and protein adsorptionpotential. A hollow fiber structure that fits these demands is incorporated in the Polyflux Revaclear and Revaclear MAX dialyzers. These features may contribute to further improvements in the outcome of high-flux hemodialysis for patients, while contributing to efficiency and economy for dialysis clinics.