Fresenius Medical Care Sees U.S. Plans for Kidney Disease as Positive
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David Thompson, Vice President and Medical Director, Critical Care, Fresenius Medical Care North America & Dinesh Chatoth, Associate Chief Medical Officer, Fresenius Medical Care North America & Shakil Aslam, Vice President and Senior Medical Director, Devices, Fresenius Medical Care North America
(Clearance values of hollow fiber dialyzer with membrane from polysulfone material for different areas1)
BIO- AND HEMOCOMPATIBILITY
During a hemodialysis treatment, activation of clotting factors and platelets results in thrombosis in the dialyzer. Activation of the complement system, with consequent activation of leukocytes can lead to:
All dialysis membranes activate complement and leukocytes to some extent, but unmodified cellulosic membranes are potent complement and leukocyte activators and are generally considered bioincompatible.
In addition, the generation of bradykinin in the presence of a dialysis membrane with an anionic surface and accumulation of the bradykinin in plasma can cause anaphylactoid reactions in the presence of ACE inhibitors.
Early disposable hollow-fiber dialyzers were shipped filled with a formaldehyde solution to maintain sterility. Later, dialyzers were sterilized with ethylene oxide (ETO) and shipped dry, but the polyurethane potting material used in hollow-fiber dialyzers can act as a reservoir for ETO. Residual ETO can diffuse into the blood during dialysis, bind to plasma proteins, and induce antibody formation, leading to intradialytic anaphylactoid reactions, so ETO has now been largely replaced by alternative sterilization methods, such as steam and irradiation.
The decision to prefer one dialyzer brand over another may include additional factors such as the overall cost of the dialysis disposables, price discounts, reliability of the supply chain, and satisfaction with customer service.
Optiflux series (Fresenius Medical Care North America) and Revaclear (Baxter) dialyzers are the most commonly prescribed dialyzers in the U.S. with a market share of 74% and 17%, respectively.
NEW TECHNOLOGY MAY OFFER ADVANTAGES FOR DIALYZERS IN THE FUTURE
There have not been many advances in dialyzer membranes and designs since the introduction of high-flux synthetic membranes a few decades ago. Some of the changes in the dialyzer membranes and designs currently being investigated include:
Most dialyzers in use today are high-flux and have similar clearance performance. Every dialysis facility must have options for patients with known hypersensitivity reactions to certain dialyzers. Dialyzers with different membrane materials and/or sterilization techniques should be available. Today, steam and gamma radiation sterilization are preferred to reduce the risk of allergic reactions associated with the use of ethylene oxide.
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