DRA is a rare, yet chronic, condition caused by blood buildup of a protein called beta 2-microglobulin. It occurs most often among people aged 60 or older who have been on dialysis for more than five years, the FDA said in a news release. Symptoms if the protein spreads to the bones may include painful and stiff joints, bone cysts and torn tendons and ligaments.
The newly approved device, the Lixelle Beta 2-microglobulin Apheresis Column, removes beta 2-microglobulin from the blood using porous cellulose beads. It is used in conjunction with hemodialysis. When the Lixelle Column is used, the blood passes through the Lixelle Column before it enters the dialysis filter.
Data supporting the safety and benefit of the device include published clinical studies including approximately 100 patients from Japan with DRA, and postmarket safety data from approximately 200 patients in Japan. The studies generally showed improvement in symptoms associated with DRA with use of the device, according to the FDA. The most common side effects noted were temporary hypotension and a drop in hematocrit.
The FDA conducted the review via the Humanitarian Device Exemption (HDE) pathway after granting it a Humanitarian Use Device (HUD) designation. As a condition of the HDE approval, post-approval study of the device’s benefits, risks and side effects among users is to be conducted in the United States, the FDA said.
The Lixelle Column is manufactured by Kaneka Corporation in Osaka, Japan and distributed in the U.S. by its subsidiary, Kaneka Pharma America.