The Food and Drug Administration (FDA) has authorized use of Lixelle Beta 2-microglobulin Apheresis Column (Kaneka Pharma America), the first device to treat dialysis-related amyloidosis (DRA).
The Lixelle Column removes beta 2-microglobulin from the blood with porous cellulose beads, which bind to beta 2-microglobulin as the patient’s blood passes over the beads, when used in conjunction with hemodialysis. The blood passes through the Lixelle Column before it enters the dialysis filter.
The safety and probable benefit of the device was reviewed through the Humanitarian Device Exemption (HDE) pathway after it was granted a Humanitarian Use Device (HUD) designation. Published clinical studies on treatment of approximately 100 patients from Japan with DRA and postmarket safety data from approximately 200 patients in Japan where the device has been approved for use were included in the review. These studies showed improvement overall in symptoms associated with DRA with use of the device.
For more information visit FDA.gov.