Clinical Study of a Nano Structure Fx80 Hollow Fiber Dialyzer

A new polysulfone hollow fiber, Helixone, manufactured using nano-controlled spinning technology has recently been introduced. This membrane has been mounted in a redesigned dialyzer, the FX Class (Fresenius Medical Care, Germany) with spiral blood inlet design and increased fibre packing density. It has unique biocompatibility, optimized clearance performance, and simplified handling characteristics. In a 6-week crossing-over clinical study we compared the traditional F80 dialyzer and FX80 dialyzer. The 15-minute percentage reduction rate on leukocyte, platelet, complement C5a was used as the observed parameter for membrane biocompatibility; as well as intradialytic reduction rate of blood urea nitrogen, creatinine, and phosphate for performance on small molecular solutes removal. To measure ease of handling, we compared the volume of normal saline and nursing time used in priming and wash-back of both dialyzer types. The results showed that the FX80 helixone dialyzer maintained good biocompatibility compared to that of the F80. Removal rate of small solutes of blood urea nitrogen, creatinine, and phosphate were higher in the FX80 than the F80 but the difference was not statistically significant which is possibly due to small sample size. The superior reduction ratio for phosphate with the FX approached significance (p=0.08). Easier handling of the FX80 compared to the F80 was confirmed by the need for less volume for prime and wash-back (P＜0.0001) and less nursing time consumed by these procedures. We conclude that the new helixone FX80 dialyzer maintains good biocompatibility, and has a trend to higher reduction rate of small solutes compared to the F80. Moreover, the Helixone hollow fiber is easier for handling during priming and rinsing back during dialysis.