What is the role of an apheresis device in beta-2-microglobulin (beta-2m) amyloidosis treatment?

Updated: Nov 14, 2019
  • Author: Anita Basu, MD, FACP; Chief Editor: Vecihi Batuman, MD, FASN  more...
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Answer

In March 2015, the US Food and Drug Administration (FDA) authorized the use of the first device to treat patients with DRA, the Lixelle Beta 2-microglobulin Apheresis Column (Kaneka Corp).  During hemodialysis, the patient's blood passes through the device before entering the dialysis filter, and porous cellulose beads in the device bind to and remove beta 2-microglobin. The FDA granted the device a Humanitarian Use Device designation, which is given if the device diagnoses or treats a disease or condition that affects or is found in fewer than 4000 individuals in the United States each year. [21]


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