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FDA Approves New Use for Liposorber Apheresis System

The U.S. Food and Drug Administration today approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is recurrence of FSGS.

FSGS is 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. FSGS causes excessive loss of protein from the blood into the urine, which may lead to nephrotic syndrome (edema, excess protein in the urine, low protein in the blood, and high cholesterol) and kidney failure. A majority of children with primary FSGS will progress to end stage renal disease and will require either kidney dialysis or a kidney transplant. About one quarter to one half of FSGS patients that receive a kidney transplant will have a recurrence of FSGS in their transplanted kidney.

"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."

The Liposorber LA-15 System, a blood processing system that is used outside the body, includes disposable components and a control/monitor unit. The device works by removing certain lipoproteins from the patient's blood. The patient's blood is first passed through a plasma filter where the blood cells are separated from plasma (the liquid component of the blood). The plasma is then further passed through two adsorption columns, which are packed with a gel designed to capture the lipoproteins in the blood. The blood cells and the treated plasma are then returned to the patient via the blood return line.

The Liposorber LA-15 System, marketed by New York-based Kaneka America Corporation, was first approved in the United States in 1996. The FDA approved it for lowering low density lipoprotein cholesterol (often called the "bad" cholesterol) in certain patients with familial hypercholesterolemia (FH) who develop very high cholesterol levels, increasing the risk for complications from the disease, including cardiovascular disease. FH patients treated with the device are those for whom dietary and drug therapies have not been effective, or for whom drug therapy cannot be tolerated.

Data in support of approval included two scientific studies – one published in a peer-reviewed scientific journal and one unpublished report. One study of 11 children with FSGS at high risk for progression to end stage renal disease showed normal or near normal renal function in most patients who achieved remission of disease after treatment with the Liposorber LA-15 System. The study authors reported only one adverse event. The other study showed that patients with FSGS who received therapy with the Liposorber LA-15 System after a kidney transplant (including some who received one treatment immediately before transplant) excreted less protein in their urine than FSGS patients who underwent a kidney transplant but received no therapy with the Liposorber LA-15 System. These study results, along with non-clinical data submitted by the company, support a determination that the Liposorber LA-15 System has probable benefit for pediatric patients for whom standard FSGS treatments are too risky, ineffective, or cannot be tolerated, and, that the device does not expose patients to unreasonable risks.

SOURCE: FDA, October 10, 2013







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