FDA OKs First Device for Dialysis-Related Amyloidosis

Troy Brown, RN

Disclosures

March 11, 2015

The US Food and Drug Administration (FDA) has authorized the use of the first device to treat patients with dialysis-related amyloidosis (DRA).

The Lixelle Beta 2-microglobulin Apheresis Column (Kaneka Corp) is distributed in the United States by Kaneka Pharma America.

DRA is a chronic, progressive condition that is a complication of kidney failure. It occurs most often in patients older than 60 years who have been using hemodialysis for longer than 5 years.

DRA is caused by an accumulation of a protein known as beta 2-microglobulin in the blood. The protein forms deposits in bones, joints, and tendons, resulting in painful, stiff joints; bone cysts that can lead to fractures; and torn tendons and ligaments. These protein deposits can also affect the digestive tract, heart, and lungs.

"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," 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, said in a news 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."

During hemodialysis, the blood passes through the device before entering the dialysis filter, and the device's porous cellulose beads bind to and remove beta 2-microglobin as the patient's blood flows over the beads.

The device may help those with symptoms related to DRA, particularly those without access to extended dialysis therapies or who may be ineligible for a kidney transplant.

Humanitarian Device Exemption

The FDA granted the device a Humanitarian Use Device designation, which is given if the device diagnoses or treats a disease or condition that affects or is found in fewer than 4000 individuals in the United States each year.

To receive approval through the exemption pathway, the company must demonstrate that the device is safe and that the benefit of its use outweighs any risk for injury or illness. The company must also demonstrate that no comparable devices are currently being marketed for the diagnosis or treatment of the disease or condition, with the exception of those approved under the Humanitarian Device Exemption or investigational device exemption.

The FDA's decision comes after a review of data from published clinical studies describing its use in approximately 100 patients from Japan with DRA and postmarket safety data from about 200 patients with DRA in Japan, where the device has already been approved for use.

In general, the studies showed symptom improvement with use of the device.

The most frequent adverse events seen with the device's use are temporary hypotension and hematocrit. These are adverse events commonly seen in patients undergoing dialysis or any extracorporeal therapy.

As a condition of the Humanitarian Device Exemption approval, the company is required to conduct a postmarket study to obtain more data on the benefits, risks, and adverse events in the US population.

Additional information can be found at:

Dr Maisel has disclosed no relevant financial relationships.

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