Baxter: US FDA Grants De Novo Application For Novel Dialysis Membrane Theranova

(RTTNews) - Baxter International Inc. (BAX) announced the U.S. Food and Drug Administration or FDA has granted the De Novo application for Theranova, the company's novel dialysis membrane.

The company noted that by granting a De Novo application, the FDA is establishing a new class of dialyzer technology with unique performance standards. The FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space, the company stated.

Theranova was designed to deliver expanded hemodialysis or HDx 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 3,4,5. These middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure3,4,5.