First Dialysis-Related Amyloidosis Treatment Device Approved Via HDE
This article was originally published in The Gray Sheet
Executive Summary
Kaneka Pharma America’s Lixelle Beta 2-microglobulin Apheresis Column gained a humanitarian device exemption after FDA agreed past studies conducted in Japan showed promise. The approval requires a postmarket study in the U.S. to better understand the safety and efficacy profile of the device.