The FDA just approved a first-of-its-kind blood purifier to treat a complication of kidney failure under its pathway for medical devices that treat rare conditions.
The Lixelle Column, made by Japan's Kaneka, has porous cellular beads that bind to and remove beta 2-microglobulin protein from the blood. Accumulation of that protein causes dialysis-related amyloidosis (DRA), and occurs most often in kidney failure patients, the FDA says, adding that the device may be especially beneficial for those not eligible for a kidney transplant or those who do not have access to extended dialysis treatment.
Symptoms of DRA include painful and stiff joints, bone cysts that can turn into bone fractures, torn tendons and torn ligaments, according to the agency.
The Lixelle Column is deployed with hemodialysis, which includes circulating blood externally and then returning it to the body. The blood goes through the device prior to entering the dialysis filter, the FDA says.
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| William Maisel |
"While DRA affects only a small population of patients on dialysis, there are not many treatment options for these patients and some options may not be available to patients in all areas," said Dr. William Maisel, chief scientist and acting director of the Office of Device Evaluation with FDA's device arm (CDRH), said in a statement. "The Lixelle Beta 2-microglobulin Apheresis Column may provide this patient population with an option for relieving some of the debilitating symptoms of DRA."
The column was deemed a Humanitarian Use Device under the Humanitarian Device Exemption pathway for devices that treat rare conditions, defined as those affecting fewer than 4,000 U.S. patients per year. It is similar to a PMA approval, but requires only a "probable" demonstration of benefits.
Possible adverse events of the Lixelle Column include low blood pressure and a decrease in red blood cell count; they are common in hemodialysis patients undergoing extracorporeal therapy, or treatment that occurs outside the body.
A postmarket study to gather more information about the device is required.
- read the announcement from the FDA