FDA Clears First-of-Kind Device To Treat Dialysis-related Amyloidosis - RTT News PDF Print

Dialysis-related amyloidosis, a complication of kidney failure, is caused by the build-up of a protein called beta 2-microglobulin in the blood. This condition, which most often occurs in adults older than 60, who have been on hemodialysis for more than five years, can cause painful and stiff joints, bone cysts, torn tendons and ligaments, and can also affect the digestive tract and organs, such as the heart and lungs.

Medication therapy, newer, more effective hemodialysis filters, surgery and kidney transplant, are the available options to treat dialysis-related amyloidosis, according to the National Kidney and Urologic Diseases Information Clearinghouse.

In a first-of-its kind device, the FDA has authorized the use of Lixelle Beta 2-microglobulin Apheresis Column, manufactured by Japan-based Kaneka Corp., to treat dialysis-related amyloidosis.

The Lixelle Column contains porous cellulose beads specifically designed to bind to beta 2-microglobulin as the patient's blood passes over the beads, thereby removing the beta 2-microglobin from the blood.

The device is to be used in conjunction with hemodialysis.When the Lixelle Column is used, the blood passes through the Lixelle Column before it enters the dialysis filter, noted the FDA.

by RTT Staff Writer

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