First device approved for dialysis-related amyloidosis

(HealthDay)—The U.S. Food and Drug Administration has approved the first device to treat dialysis-related amyloidosis (DRA), a complication of dialysis used to treat kidney failure.

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 the protein from the blood using porous cellulose beads. It was evaluated among 100 clinical trial patients in Japan.

The most common side effects noted were temporary low blood pressure and a drop in red .

The FDA ordered Japanese device maker Kaneka Corp. to conduct a post-approval study of the device's benefits, risks and side effects among users in the United States, the FDA said.


Explore further

Natpara approved for hormone disorder causing low blood calcium

More information: The FDA has more about this approval.

Copyright © 2015 HealthDay. All rights reserved.

Citation: First device approved for dialysis-related amyloidosis (2015, March 6) retrieved 23 January 2020 from https://medicalxpress.com/news/2015-03-device-dialysis-related-amyloidosis.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
7 shares

Feedback to editors

User comments