Profile: Kaneka Pharma America LLC specializes in offering Liposorber® for acute lowering of LDL-cholesterol. The Liposorber LA-15 LDL apheresis system is used for performing LDL apheresis to acutely remove LDL-C from the patient's plasma. It is comprised of a tubing set, a hollow fiber plasma separator (Sulflux FS-05) and two dextran sulfate LDL-adsorption columns (Liposorber LA-15), which is our patented technology. The MA-01 is the computer-automated system that controls the entire LDL apheresis procedure. The Liposorber LA-15 LDL apheresis system is approved by the FDA and indicated for use to acutely remove LDL-C from the plasma of the high-risk patient populations for whom diet has been ineffective & maximum drug therapy (such as Statins) has been ineffective or not tolerated. The patient's blood is withdrawn via a venous access and enters the plasma separator. As blood is pumped through the hollow fibers in the plasma separator, plasma is separated and exits from the plasma outlet. The remaining blood, including red and white blood cells & platelets, exits from the blood outlet. The cell-free plasma is pumped into one of the two LDL adsorption columns. As the plasma passes through the column, the apolipoprotein B-containing lipoproteins LDL, VLDL, and Lp(a) are selectively adsorbed in the column. The LDL-depleted plasma exits the column, passes through a membrane filter and is recombined with the blood cells originally exiting the plasma separator. This recombined blood and plasma flows through a built-in blood warmer & is returned to the patient via a second venous access.

The company is CE Mark certified.

FDA Registration Number: 2435151