This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Liposorber® LA-15 System
HDE Applicant: Kaneka Pharma America LLC
Address: 546 Fifth Ave., 21st Floor, New York, NY 10036
Approval Date: October 10, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf12/h120005a.pdf
What is it? The Liposorber LA-15 System is a blood processing system that is used outside the body. It includes disposable components and a control/monitor unit. The device works by removing certain lipoproteins from a patient’s blood. The Liposorber LA-15 System is used to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after kidney (renal) transplantation in which there is recurrence of FSGS.
How does it work? A 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.
When is it used? 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.
The Liposorber® LA-15 System is indicated for use in the treatment of pediatric patients with nephrotic syndrome associated with primary FSGS, when
- Standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, are unsuccessful or not well tolerated and the patient has a GFR ≥ 60 ml/min/1.73m2 or
- The patient is post renal transplantation.
What will it accomplish? The adsorption columns have been shown to effectively remove lipids from the plasma in adults with familial hypercholesterolemia. The device system may also provide a similar benefit to many pediatric patients with FSGS who also have hyperlipidemia. The Liposorber® LA-15 Adsorption Columns may also remove other factors in the blood, including substances that help FSGS progress.
When should it not be used? This device should not be used in:
- patients who have been treated with ACE-inhibitors within the past 24 hours;
Severe analylactic reactions, including shock, have occurred in patients treated with the Liposorber LA-15 while being treated with ACE-inhibitor medication. The risk of an anaphylactic reaction may be reduced by not giving ACE inhibitors for approximately 24 hours before each treatment. The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual’s kidney function and the ACE-inhibitor being used. If required, an ACE-inhibitor can be given after the apheresis treatment is complete.
- patients who have clotting disorders, such as those with severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or who are receiving vitamin K antagonist medications after surgery;
- patients unable to tolerate therapy with Liposorber® LA-15, such as those with severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, or severe uncontrollable hypertension or hypotension; and
- patients with hypersensitivity to dextran, heparin or ethylene oxide.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Probable Benefit and labeling are available online.