US FDA approves pediatric rare disease medical device

The US FDA has approved the Liposorber LA-15 System to treat pediatric patients with the rare disease primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is recurrence of FSGS.

"Primary FSGS is a rare disease. 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."

Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health.

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.

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. 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.

The Liposorber LA-15 System was first approved in the United States in 1996 and is marketed by New York-based Kaneka America Corporation.