US health regulators cleared use of a first-of-its-kind device to treat dialysis-related amyloidosis (DRA).
The US Food and Drug Administration (FDA) authorized use of Lixelle Beta 2-microglobulin Apheresis Column under its pathway for medical devices that treat rare conditions. The device is used to treat DRA, a chronic, progressive condition caused by the buildup of beta 2-microgobulin. DRA is a complication of kidney failure. As beta 2-microglobulin builds up in the blood, deposits of the protein can form in the bone, joints and tendons, causing painful and stiff joints, bone cysts that can lead to fractures and torn tendons and ligaments. Beta 2-microglobulin deposits can also affect the digestive tract and organs, including the heart and lungs. DRA most often occurs in patients with kidney failure, particularly those over the age of 60, who have been on hemodialysis for more than five years.
The device, made by Japan’s Kaneka, has porous cellular beads that bind to and remove beta 2-microglobin from the blood. The Lixelle Column is used in conjunction with hemodialysis, which includes circulating the blood externally and returning the clean blood to the body. The blood passes through the device prior to entering the dialysis filter.
According to the agency, the device could help patients who have developed symptoms related to DRA and could be especially useful for those who may not have access to extended dialysis therapies or who may not be eligible for a kidney transplant.
“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 Office of Device Evaluation in FDA’s Center for Devices and Radiological Health. “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 agency granted the device a Humanitarian Use Device (HUD) designation, intended for devices designed to treat or diagnose a condition that affects fewer than 4,000 people in the US per year.
The approval was based on data supporting the safety and probable benefit of the Lixelle Column in clinical studies. These studies generally showed improvement in symptoms associated with DRA with use of the device. The most common adverse events associated with the device include low blood pressure and a decrease in red blood cell count. These adverse events are common among patients undergoing dialysis or any extracorporeal therapy.
The agency requires that Kaneka conduct a post-market study to gain more data on the benefits, risks and adverse events in the US.
Source: US Food and Drug Administration
Last updated: 3/9/14; 2:25pm EST