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., 22nd Floor, New York, NY 10036
Approval Date: March 20, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/H170002A.pdf
What is it? The LIPOSORBER LA-15 System is a blood processing system that collects blood from the patient's body and removes certain substances such as low density lipoprotein cholesterol (LDL-C, or "bad cholesterol") and other harmful substances from the patient's blood. The system also helps slow the progression of an aggressive kidney disease called Focal segmental glomerulosclerosis (FSGS).
The system is comprised of a tubing set, two blood filters, two blood storage columns, and a computer that controls the entire system.
How does it work?
- Blood is withdrawn from the patient's arm via a large tube (catheter) placed in a large vein.
- The blood is combined with heparin (a blood thinner which helps keep the blood from clotting while outside the body) and pumped via plastic tubes into another device that separates the plasma (part of blood that contains nutrients and other essential chemicals) from the blood cells (such as white blood cells that fight infection). The blood cells are stored in a separate area while the plasma is treated.
- The plasma is then delivered to two special filters that trap and remove LDL-C and possibly other harmful substances.
- The plasma is then re-united with the blood cells and returned to the patient.
- Immunosuppressive treatment options, such as corticosteroid and/or calcineurin inhibitors are unsuccessful or not well tolerated, and the patient has a glomerular filtration rate (GFR) ≥ 60 ml/min/1.73m2 or
- The patient is post kidney transplantation.
What will it accomplish? The LIPOSORBER® LA-15 system traps and removes LDL-cholesterol in the blood. By removing the bad cholesterol, the system may reduce the likelihood of developing serious disease of the heart and blood vessels. The system may also trap and remove other harmful substances contributing to the progression of the kidney disease.
The system also helps slow the progression of FSGS in adult and pediatric patients.
When should it not be used? This device should not be used in:
- Patients who have been treated with a group of blood pressure-lowering drugs called ACE-inhibitors within the past 24 hours;
- Clinical data shows that severe allergic reactions, including shock, may occur in patients treated with the LIPOSORBER® LA-15 system while the patient is also receiving an ACE-inhibitor medication. The risk of this allergic reaction may be minimized by withholding the administration of ACE inhibitors for approximately 24 hours before each device system treatment.
- Patients for whom adequate blood thinning cannot be achieved, such as those with diseases such as severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or, patients who are receiving medications that block the actions of vitamin K after surgery.
- Patients who cannot tolerate blood being drawn for up to 3-4 hours. The treatment may result in severe and life-threatening heart problems or blood pressure instability.
- Patients with who cannot tolerate exposure to materials in the device system such as ethylene-vinyl alcohol copolymer; or medications used during the treatment such as dextran, heparin or ethylene oxide.
Additional information (including warnings, precautions and adverse events):