Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Extraneal (icodextrin), a peritoneal dialysis (PD) solution. This solution offers the potential for increased removal of fluid from the blood stream during dialysis (known as ultrafiltration) over currently available 1.5% and 2.5% dextrose solutions during long dwell dialysis exchanges. Extraneal is the first solution with a new class of osmotic agent introduced for PD patients in the United States.

"I am excited about the FDA's approval of Extraneal, which gives physicians a new approach to addressing fluid management issues for numerous peritoneal dialysis patients in the United States," said John Burkart, Professor of Internal Medicine and Director of Outpatient Dialysis, Nephrology Division at Wake Forest University School of Medicine, North Carolina. "Effective fluid management or ultrafiltration is a primary goal of PD therapy, and now with the introduction of Extraneal, we can help to optimize the treatment in a new way for our patients."

Extraneal is indicated for a single daily exchange for the long dwell (8- to 16-hours) during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of chronic renal failure.

"Dwell" is the amount of time dialysis solution remains in the abdominal cavity during PD therapy, which is usually performed in the home. "Exchange" refers to the process of discarding used dialysis solution and instilling fresh dialysis solution into the abdominal cavity. Ultrafiltration is the removal of fluid from the bloodstream during dialysis.

Prior to Extraneal, dialysis solutions available in the United States used glucose as the osmotic agent, which acts as the driving force in the removal of fluids. Extraneal solution uses a novel osmotic agent, which is a polymer of glucose, to remove greater amounts of fluid over the long dwell period as compared to standard 1.5% and 2.5% dextrose solutions. During long dwell dialysis exchanges with prior solutions, more dialysis fluid may be absorbed into the blood stream than is removed by ultrafiltration, which translates into less effective fluid removal. Fluid removal is a cornerstone of dialysis therapy, since the patient's native kidneys have limited, if any, residual ability to eliminate excess fluid from the bloodstream.