The U.S. Food and Drug Administration has given its approval for the use of the Liposorber LA-15 System to treat pediatric patients with primary fundamental glomerulosclerosis, a chronic disease in which scar tissue develops on the parts of the kidneys that filter waste out of the blood and in other essential parts of the kidney. As a result the body loses an excessive amount of protein from the blood into the urine, which may then lead to nephrotic syndrome (edema, excess protein in the urine, low protein in the blood, and high cholesterol) and kidney failure.
“Primary FSGS is a rare disease,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This approval provides a treatment option for children with primary FSGS when standard treatment options, including diet modifications and drug therapies, are unsuccessful or not well tolerated.”
Most children suffering from primary FSGS end up with final stage renal disease and will require either kidney dialysis or a kidney transplant. About 25%-50% of FSGS patients that receive a kidney transplant will have a recurrence of FSGS in their transplanted kidney.
The LA-15 System, a blood processing system that is used outside the body by removing certain lipoproteins from the patient’s blood, first passing it through a plasma filter where the blood cells are separated from plasma. The plasma is then passed through two absorption columns, which are packed with a gel designed to capture the lipoproteins in the blood. Finally, the blood cells and treated plasma are then returned to the patient via the blood return line.
The Liposorber LA-15 System was first approved to lower low density lipoprotein cholesterol (“bad” cholesterol) in certain patients with familial hypercholesterolemia bby the FDA in 1996.
For more information about primary fundamental glomerulosclerosis readers can contact the National Kidney Foundation at 30 E. 33rd St., New York, NY 10016 800 622-9010.