Baxter’s Data on Expanded Hemodialysis

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Baxter International, in Deerfield, IL, has released data from two independent studies that explored expanded hemodialysis therapy (HDx) with its Theranova™ dialyzer. Expanded hemodialysis refers to applying high retention-onset membranes able to filter out molecules in the mid- to high molecular weight range.

Nephros (South Orange, NJ) gained FDA approval in 2012 for its hemodiafiltration system, the first in the US. Whereas dialysis works on a diffusion principle and filters smaller molecules, hemodiafiltration provides an extra boost of cleansing because it moves molecules through a fluid under pressure and forces out the large waste molecules that might otherwise remain.

The data compared outcomes of the Baxter dialyzer’s ability to perform HDx versus outcomes with hemodiafiltration and were presented at the 55th Congress of the European Renal Association and European Dialysis and Transplant Association meeting in June. In both studies, HDx with the Baxter dialyzer was equivalent to the results of hemodiafiltration.

Baxter is hoping for FDA approval and announced a multicenter, prospective, randomized controlled clinical trial to support data submission for FDA marketing authorization. The system is already available in other parts of the world, including parts of Europe and Latin America, as well as Australia and New Zealand.