FDA Approves First Dialysis-Related Amyloidosis Device
The FDA today authorized the use of the first device approved to treat dialysis-related amyloidosis.
The FDA today authorized the use of Kaneka’s Lixelle Beta 2-microglobulin Apheresis Column, the first device approved to treat dialysis-related amyloidosis (DRA).
A common complication of kidney failure, DRA occurs when a protein called beta 2-microglobulin builds up in the blood, forming deposits in a patient’s bones, joints, and tendons. While this condition often causes painful and stiff joints, bone cysts and fractures, and torn tendons and ligaments, it can also affect a patient’s digestive tract and organs.
Used in conjunction with hemodialysis, the Lixelle Column filters out beta 2-microglobin from recirculated blood before returning clean blood the body. The device may be particularly helpful to patients who lack access to extended dialysis therapies or who are ineligible for a kidney transplant, according to an FDA press release.
“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 William Maisel, MD, MPH, deputy director for science, chief scientist and acting director of the FDA’s Office of Device Evaluation, in a press release. “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 FDA based its nod on the results of clinical trials that evaluated the Lixelle Column’s safety and efficacy in 100 patients with DRA, as well as on postmarket safety data from approximately 200 patients in Japan, where the device has been previously approved. Researchers found that the use of the device led to improvements in DRA symptoms.
The most common adverse events associated with the use of the Lixelle Column included temporary hypotension and a decrease in red blood cell count, both of which are frequently experienced by patients undergoing dialysis or other extracorporeal therapies. As a condition of its approval, the FDA is requiring Kaneka to conduct postmarket studies to assess the device’s benefits, risks, and adverse events in US patients.