Baxter gets FDA authorization for dialysis therapy

DEERFIELD - The U.S. Food and Drug Administration has granted the De Novo application for Baxter International Theranova, a novel dialysis membrane.

Theranova was designed to deliver expanded hemodialysis therapy, which filters a wider range of molecules from the blood than traditional hemodialysis filters, like high-flux membranes, by targeting effective removal of conventional and large middle molecules. The middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.

The FDA uses the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States and such designations are rare in the dialysis space

"U.S. patients on HD deserve more options than are currently available to them, and we are taking extraordinary steps to support their access to Theranova," said Gavin Campbell, general manager of Baxter's U.S. Renal Care business. "Patients are currently treated with HDx enabled by Theranova in more than 40 countries worldwide, and we are doing everything we can in the U.S. to ensure health care providers can also realize the full value of this therapy for their patients on HD."