Indications For Use (FH)
The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma of the following high risk patient populations for whom diet has been ineffective and maximum drug therapy has been either ineffective or not tolerated:
- Group A. Clinically diagnosed Familial Hypercholesterolemic Homozygotes with LDL-C > 500 mg/dL;
- Group B. Clinically diagnosed Familial Hypercholesterolemic Heterozygotes with LDL-C ≥ 300 mg/dL;
- Group C. Clinically diagnosed Familial Hypercholesterolemic Heterozygotes with LDL-C ≥ 100 mg/dL and either documented coronary artery disease or documented peripheral artery disease; and
- Group D. Clinically diagnosed Familial Hypercholesterolemic Heterozygotes with LDL-C ≥ 100 mg/dL, lipoprotein(a) [Lp(a)] ≥60 mg/dL and either documented coronary artery disease or documented peripheral artery disease.1
How LIPOSORBER® Works
- Blood is withdrawn and goes through the plasma separator.
- Plasma passes through the LIPOSORBER Adsorption Column, selectively removing LDL, Lp(a) and VLDL.
- Plasma is recombined with blood cells and passes through the blood warmer, then is returned to the patient.
- After the first cycle is complete, the computer-regulated machine automatically switches the plasma flow from the primary LIPOSORBER Adsorption Column to the secondary column after 600 ml of blood has been processed.
- The primary column is regenerated, eluting waste and re-primed to be ready for the next cycle of adsorption.
*Individual treatments may vary. Please consult with your doctor.
Selectivity & Efficacy
Selectivity Feature1
The adsorbent columns are made of dextran sulfate cellulose beads, which provides specific binding to Apo-B containing lipoproteins such as LDL-C, Lp(a), and VLDL.
These three are selectively removed by the electro-static interaction between the negatively charged dextran sulfate and the positively charged moiety of Apo-B. Unlike therapeutic plasma exchange (TPE), LIPOSORBER minimally affects other blood components.
The system effectively removes harmful atherogenic lipoproteins such as Apo-B containing lipoprotein (Lp(a), LDL-C, and VLDL) associated with serious cardiovascular disease and vascular complications in FH patients.
Clinical Outcomes
Long-term efficacy of lipoprotein-apheresis (LA) on coronary heart disease in familial hypercholesterolemia was studied. Investigators examined long-term efficacy and safety of LA in heterozygotes familial hypercholesterolemia (HeFH) patients with history of CHD. LA was shown to be an effective and well tolerated treatment for HeFH: 58% acute reduction in LDL-C levels and 72% reduction in total coronary events.2*
*Lipoprotein-apheresis was used for this study but LIPOSORBER was not specifically mentioned.
Side Effects1
ADVERSE EVENTS: The most common adverse events are hypotension (0.8%),nausea/vomiting (0.5%), and flushing/blotching (0.4%). Other adverse reactions in-clude angina/chest pain, shortness of breath, fainting, lightheadedness and anemia.
CONTRAINDICATION: Angiotensin converting enzyme [ACEI(s)] inhibitors are contraindicated with LIPOSORBER® due to possible bradykinin reaction. ACEI(s) should be replaced with angiotensin II receptor blockers (ARBs) or any other antihypertensive agent as determined by the prescribing physician.
For complete safety information, including adverse events and contraindications, please refer to the Instructions For Use Manual.
References:
- Kaneka Medical America LLC., 2022, LIPOSORBER®LA-15 SYSTEM Operator’s Manual No.1002en-R7, Section IV.
- Mabuchi, H et al. “Long-term efficacy of low-density lipoprotein apheresis on coronary heart disease in familial hypercholesterolemia.” Hokuriku-FH-LDL-Apheresis Study Group. The American journal of cardiology vol. 82,12 (1998): 1489-9 doi:10.1016/s0002-9149(98)00692-4
