The current status of therapeutic apheresis devices in the United States.

Over the last 40 years, plasmapheresis technology and its indications for use have been continually evolving. With the growing incidence for autoimmune diseases, unsatisfactory therapeutic options, side effects of drug therapy, and economic relevance, apheresis clinicians have been leaning toward more selective plasmapheresis techniques through the use of plasma fractionators and immunoadsorption columns. Plasma fractionators are mostly used in Asia, and rarely utilized in the U.S. The majority of plasma filters approved by the Food and Drug Administration (FDA) are primary membrane plasma separators, which still require replacement fluid. The secondary plasma fractionators available in the U.S. are limited in used and mostly investigational. Immunoadsorption columns, mostly used in Europe, are gaining popularity in the U.S. Some FDA-approved immunoadsorption columns include the Prosorba protein-A silica column, Immunosorba tryptophan and phenylalanine columns, Immunosorba protein-A sepharose column, and Liposorber dextran sulfate column. In addition, the heparin-induce extracorporeal lipoprotein precipitation (HELP) system is also FDA-approved. However, there are other immunoadsorption technologies used in Europe, such as direct adsorption lipoprotein LDL-hemoperfusion, not yet available in the U.S. While each method of apheresis carries its own risks and benefits, it is the opinion of the authors that these additional apheresis techniques be available to U.S. researchers and clinicians as a therapeutic option. The authors believe that the U.S. need to aggressively investigate more specific plasmapheresis modalities and establish appropriate dialogue with regulatory and reimbursement officials for FDA-approval of these devices.