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Review
. 2025 Apr 30;15(5):132.
doi: 10.3390/membranes15050132.

Development and Investigation of a New Polysulfone Dialyzer with Increased Membrane Hydrophilicity

Adam M Zawada  1 , Bettina Griesshaber  2 , Bertram Ottillinger  3 , Ansgar Erlenkötter  4 , Nathan Crook  5 , Skyler Boyington  5 , Manuela Stauss-Grabo  2 , James P Kennedy  6 , Thomas Lang  2
Affiliations
Review

Development and Investigation of a New Polysulfone Dialyzer with Increased Membrane Hydrophilicity

Adam M Zawada et al. Membranes (Basel). .

Abstract

Innovation in dialysis care is fundamental to improve well-being and outcomes of patients with end-stage kidney disease. The dialyzer is the core element of dialysis treatments, as it largely defines which substances are removed from the patient's body. Moreover, its large surface size is the major place of interaction of the patient's blood with artificial surfaces and thus may lead to undesired effects such as inflammation or coagulation. In the present article we summarize the development path for a new dialyzer, including in vitro and clinical evidence generation. We use the example of the novel FX CorAL dialyzer, which has recently entered European and US markets, to show which steps are needed to develop and characterize a new dialyzer. The FX CorAL dialyzer includes a new hydrophilic membrane, which features reduced protein adsorption, sustained performance, and an improved hemocompatibility profile, characterized in numerous in vitro and clinical studies. Safety evaluations revealed a favorable profile, with low incidences of adverse device effects. Insights gained from both in vitro and clinical studies contribute to the advancement of dialyzer development, ultimately leading to improved patient care.

Keywords: dialyzer; end stage kidney disease; hemocompatibility; hydrophilicity; membrane; performance.

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Conflict of interest statement

A.M.Z., B.G, A.E., S.B., N.C., M.S.-G., J.P.K. and T.L. are employees of Fresenius Medical Care and may hold stock in the company. B.O. reports consulting fees from Fresenius Medical Care.

Figures

Figure 1
Figure 1
Outer dialyzer designs. Design 1 with blood inlet and outlet in vertical direction; Design 2 with inlet and outlet in horizontal direction, and dialysate ports within the flanges. The flange of design 2 leads to a spiral blood flow while the pinnacle structure within the housing allows dialysate entering from all sides and prevents detachments of the potting from the housing.
Figure 2
Figure 2
Measurement of hydrolayer. (A) Atomic force microscopy (AFM) determination of hydrolayer thickness. Membranes are cut open and exposed to water. Contact of the tip to the hydrolayer and membrane surface leads to a deflection of the cantilever. (B) For analysis, deflection of the cantilever is plotted in a force-distance diagram and the curved portion represents the thickness of the hydrolayer. (C) FX CorAL membrane shows a significantly thicker hydrolayer than the FX CorDiax (n = 30 each, *** p < 0.001). (D) AFM characterization of membrane surface in dry and wet conditions for FX CorDiax and FX CorAL.
Figure 3
Figure 3
β2-microglobulin removal rates (least square mean ± standard error) of FX CorAL and comparators in the four randomized controlled trials eMPORA I, eMPORA II, comPERFORM, and eMPORA III [39,40,41,42].
Figure 4
Figure 4
Relative sCb5-9 levels during treatment with of FX CorAL and comparators in the three randomized controlled trials eMPORA I, eMPORA II, and eMPORA III [39,40,42]. FX CorAL is used as reference.
See this image and copyright information in PMC

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