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FX-Dialysatoren – Blau macht den Unterschied

FX CorAL

Belong together
Klinische Performance +
Hämokompabilität

Kleine Details können bei medizinischen Ergebnissen einen gewaltigen Unterschied ausmachen.

Warum FX-Dialysatoren den entscheidenden Unterschied ausmachen

FX-Dialysatoren wurden bisher bei mehr als 500 Millionen Behandlungen weltweit eingesetzt. Als weltweit führender Anbieter von Dialyseprodukten möchte Fresenius Medical Care etwas verändern – für Patienten und das medizinische Fachpersonal.

Mit kontinuierlicher Innovation und unserem Anspruch, die höchsten Qualitätsstandards zu erfüllen, richten wir unser Portfolio an FX-Dialysatoren auf die individuellen Bedürfnisse der Patienten aus.

FX portfolio

Alle FX-Dialysatoren können ein breites Spektrum an urämischen Toxinen entfernen, Endotoxine effektiv zurückhalten und sie bieten intrinsische Biokompatibilität.

Durch eine reibungslose Behandlung können wir uns mehr auf den Patienten konzentrieren – das macht den Unterschied aus.

Diese FX-Merkmale machen den Unterschied

Durch die Kombination mehrerer moderner Technologien wurden die charakteristischen Funktionsmerkmale der FX-Dialysatoren geschaffen. Zusammen machen sie den Unterschied im Hinblick auf effiziente Patientenergebnisse, reibungslose Handhabung und Kosteneinsparungen aus.

You have the possibility to choose values underneath, that matter most to you individually.
There are 3 different kind of values. Feel free to check all of them!

By "checking" the most important ones, you will recieve further information for all therapies: dialysis, transplantation and conservative care.

Please be aware, that it might make sense to start only with some values, max 3, as there are quite some information on the following pages.

Simplified workflows

The FX Dialyzers are developed for system compatibility, perfectly fitting into automatic priming procedures with low rinsing volumes and short preparation times. In addition, there is no need to turn any FX Dialyzer during the priming procedure. Moreover, the FX Dialyzers have a removable label that can easily be attached to patient records, allowing for quick documentation.

Simplified workflows, user-friendly handling and short preparation time support the nursing staff’s daily work — freeing up resources to focus more on patients.

Improved clearances

Fresenius Medical Care’s Nano Controlled Spinning (NCS™) technology creates fibers with a highly defined membrane architecture. Precise nanoscale modulation of pore size, structure and distribution favors minimal resistance to solute transfer across the membrane and contributes to improved clearances compared to macro-design membranes.10,11

Additionally, the microwave fiber structure enables the homogenous distribution of dialysis fluid, supported by the inner housing’s pinnacle design of the FX Dialyzers. It prevents the channelling of the dialysis fluid and ensures that each fiber within the bundle is perfectly surrounded by the dialysis fluid.11,12,13

Enhanced performance

The optimized header design of the FX Dialyzers ensures a homogenous blood flow path. Its geometry allows a spiral distribution of blood in the dialyzer header, preventing low velocity stagnation zones and resulting in an enhanced performance.11

Setting the standard

Each FX Dialyzer is individually sterilized by the unique INLINE steam sterilization method. Both the blood and the dialysate compartments of the dialyzer are rinsed continuously with steam at a minimum temperature of 121° C.

Rinsing with hot steam assures a gentle sterilization — without the need for chemicals or irradiation, which may lead to increased cytotoxic14 and carcinogenic residuals.15,16

Optimal use of resources

The INLINE steam sterilization process allows for the efficient use of resources during preparation as well as a reduction of costs, since only 500 mL rinsing volume is required. The process

  • includes a 100% fiber integrity test, aimed at minimizing the risk of blood leakages due to fiber ruptures
  • ensures that all FX Dialyzers are already pre-rinsed and ready to use upon arrival, resulting in short rinsing time and low rinsing volumes.
     

Best choice for high biocompatibility

Cytotoxicity is minimal after steam sterilization, whereas it increases with gamma irradiation.14 Studies have shown that with steam sterilized dialyzer membranes, less oxidative stress is induced to the patient’s blood compared to gamma sterilization.17,18,19

Performance characteristics remain intact

Changes of the material properties can be observed after sterilization with gamma irradiation, while the material remains intact in this respect when using steam sterilization.20

Increased losses of albumin during dialysis sessions have been observed with gamma sterilized dialyzers which were stored for a longer time.14,21

Adding value across the entire life cycle

Fresenius Medical Care has implemented an approach based on the Life Cycle Assessment (LCA) methodology, which follows the structure and requirements of EN ISO 14040/44: 2006:

  • Comprehensive assessment of a product’s environmental impact across its full life cycle, from materials supply to manufacturing, distribution, use and final disposal
  • Identification of improvement opportunities through environmentally sound processes, materials and design choices.
     

Lightweight material is essential for environmental sustainability

The advanced housing material of any FX Dialyzer is made of environmentally friendly and lightweight polypropylene. Due to the advanced material, FX Dialyzers up to 50% lighter (before treatment) than dialyzers made of polycarbonate22 
This may result in improved end-of-life management by producing less waste23 and contributing to cost savings.

Improved eco-performance

Across 15 environmental impact categories24, the overall eco-performance of an FX Dialyzer (FX classix 80) is notably better — on average by 42 % — compared to a reference dialyzer made from polycarbonate (HF 80S).25

Der Unterschied ist, dass man sich während der gesamten Behandlung wohl fühlt.

FX Blue Art Project

Dialysatoren sind lebensrettende medizinisch-technische Kunstwerke. Das fortschrittliche Design der FX-Dialysatoren verleiht ihnen eine neue Dimension. Sie spiegelt die Ideen, die Sorgfalt und die Qualität wider, die in die Konstruktion eingeflossen sind. Als das auffälligste sichtbare Merkmal wurde die blaue Farbe der Kappe des FX-Dialysators zur Inspiration für unser einzigartiges Blue Art Project. Wir baten Künstler, die Vorteile der FX-Dialysatoren auf ihre eigene Art zu interpretieren — sei es symbolisch oder abstrakt, poetisch oder surreal, zwei- oder dreidimensional — mit unglaublichen Ergebnissen.

Jeder Künstler verlieh den unverwechselbaren Funktionseigenschaften der FX-Dialysatoren eine andere Bedeutungsebene, eine eigene Interpretation oder eine neue Perspektive. Warme und einfühlsame, intellektuelle und bedeutungsvolle Ansätze bildeten sich heraus.

Verlässlichkeit und Erfahrung machen den Unterschied bei der Suche nach den besten Lösungen aus.

Verwandte Inhalte

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    1 Wagner S. et al., Nephrology Dialysis Transplantation (2017); 32 (3): iii615.

    2 Bock A. et al., J Am Soc Nephrol (2013); 24: SA-PO404.

    3 Maduell F. et al., Blood Purif. (2014); 37(2): 125-130.

    4 Lim P. S. et al., Artif Organs (2017); Nov 27. doi: 10.1111/aor.13011.

    5 Schindler R. et al., Clin. Nephrology (2003); 59: 447–454.

    6 Weber V. et al., Artif Organs (2004); 28(2): 210-217.

    7 Chazot C. et al., Nephron (2015); 129: 269-275.

    8 Tsai I.J. et al., Pediatr Nephrol (2014); 29: 111–116.

    9 Data from Fresenius Medical Care Deutschland GmbH: Comparison clearance values F8 HPS (effective surface area 1.8 m2) versus FX 8 (effective surface area 1.4 m2).

    10 Ronco C., Nissenson A. R., Blood Purif (2001); 19: 347-352.

    11 Ronco C. et al., Kidney International (2002); 61 (80): 126-142.

    12 Külz M. et al., Nephrol Dial Transplant (2002); 17: 1475-1479.

    13 Mandolfo S. et al., The International Journal of Artificial Organs (2003); 26 (2): 113-120.

    14 Allard B. et al., Le Pharmacien Hospitalier et Clinicien (2013); 48 (4): 15-21.

    15 Shintani H., Biomedical instrumentation & technology (1995); 29 (6): 513–519.

    16 Hirata N. et al., Radiation Physics and Chemistry (1995); 46 (3): 377–381.

    17 Golli-Bennour E. E. et al., International urology and nephrology (2011); 43 (2): 483–490.

    18 Azzabi A. et al., Néphrologie & Thérapeutique (2014); 10 (5): 318.

    19 Golli-Bennour E.E et al., World J Nephrol Urol (2017); 6 (1-2): 14-17.

    20 da Silva Aquino K. A., INtechOpen (2012); www.intechopen.com/books/gamma-radiation/sterilization-by-gamma-irradiation (27.04.2018).

    21 Dawids S., Handlos V. N., Developments in hematology and immunology (1989); 347–368.

    22 Unpublished data from Fresenius Medical Care Deutschland GmbH: Internal calculation based on weight measurements before treatment of FX Dialysers versus F-series dialysers.

    23 Unpublished data from Fresenius Medical Care Deutschland GmbH: Internal calculation based on weight measurements of FME FX classix 80 versus FME HF 80S. The typical number of treatments in most clinics is approximately 10,000 per year; this results in about 1,600 kg less waste being produced annually with FX classix 80 when used on FME 5008 CorDiax machine.

    24 EC-JRC-IES (2011): ILCD handbook – Recommendations for LCIA in the European context. Source: publications.jrc.ec.europa.eu/repository/handle/JRC61049 (all 15 environmental impact categories with recommendation in table 1 of this ILCD handbook have been evaluated).

    25 Unpublished data from Fresenius Medical Care Deutschland GmbH internal study (2018): Comparative life cycle assessment of selected FME dialysers. Eco-performance is always calculated versus baseline product (FME HF 80S); long distance scenario illustrated.

    26 Melchior, P. et al. (2021). Complement activation by dialysis membranes and its association with secondary membrane formation and surface charge. Artificial Organs, 00, 1-9. https://doi.org/10.1111/aor.13887

    27 Zawada, A. et al. (2021). Polyvinylpyrrolidone in hemodialysis membranes: Impact on platelet loss during hemodialysis. Hemodialysis International, 25, 1– 9. https://doi.org/10.1111/hdi.12939

    28 Ehlerding, G. et al. (2021). Performance and hemocompatibility of a novel polysulfone dialyzer: a randomized controlled trial. Kidney360, 2(6), 937-947 https://doi.org/10.34067/KID.0000302021

    29 Ehlerding, G. et al. (2021). Randomized comparison of three high-flux dialyzers during high volume online hemodiafiltration – the comPERFORM study, Clinical Kidney Journal; sfab196. https://doi.org/10.1093/ckj/sfab196

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