Liposorber Apheresis System Approved for Pediatric Use
The FDA approved Kaneka America Corporation's Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal transplantation in which there is a recurrence of FSGS.
It is specifically indicated for pediatric patients for whom standard treatments are too risky, ineffective, or cannot be tolerated, and for whom the device does not expose to unreasonable risks.
The Liposorber LA-15 System includes disposable components and a control/monitor unit. The patient's blood is passed through a plasma filter where the blood cells are separated from plasma. This then is passed through two adsorption columns, which are packed with a gel designed to capture lipoproteins in the blood. The filtered blood cells and treated plasma are then returned to the patient via the blood return line.
The approval for pediatric use is based on a peer-reviewed scientific journal and one unpublished report. One study (n=11) of 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 after treatment with the Liposorber LA-15 System.
The other study showed that patients who received therapy with the Liposorber LA-15 System post-renal transplant excreted less protein in their urine than patients who did not receive therapy with the Liposorber LA-15 System.
In 1996, the FDA first approved the Liposorber LA-15 System to lower low density lipoprotein (LDL) cholesterol in patients with familial hypercholesterolemia if dietary and drug therapies have not been effective, or if drug therapy could not be tolerated.
For more information call (888) INFO-FDA or visit the NIHL Rare Diseases Network.