The LIPOSORBER® LA-15 System offers an advanced apheresis treatment for patients suffering from nephrotic syndrome associated with primary Focal Segmental Glomerulosclerosis (FSGS). It is a vital option for those who have not responded well to, or cannot tolerate, standard drug therapies.

Indications For Use: Who is LIPOSORBER® For?

The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary FSGS when:

Standard treatment options, including corticosteroids and/or calcineurin inhibitor treatments, are unsuccessful or not well tolerated, AND the patient’s Glomerular Filtration Rate (GFR) is ≥ 60 ml/min/1.73 m2
OR the patient is post-renal transplantation.

How LIPOSORBER® Works: The Treatment Process

LIPOSORBER® employs a simple, automated process to target and remove harmful lipoproteins that may contribute to kidney disease.

Blood is withdrawn from the patient and channeled through a plasma separator.
The separated plasma passes through the LIPOSORBER Adsorption Column, which selectively removes Apo-B-containing lipoproteins such as LDL, Lp(a), and VLDL.
The filtered plasma is recombined with the patient’s blood cells, warmed, and then returned to the patient.
The computer-regulated machine automatically switches to a secondary column after processing 600ml of blood, allowing the primary column to regenerate and prepare for the next cycle of adsorption.

(Please note: the exact process may vary by patient and treating facility.)

Selectivity & Efficacy: Targeting the Root of Proteinuria

Targeted Selectivity Feature

The specialized adsorbent columns are made of dextran sulfate cellulose beads. This material provides highly specific binding to Apo-B containing lipoproteins (LDL-C, Lp(a), and VLDL).

These lipoproteins are selectively removed via an electrostatic interaction between the negatively charged dextran sulfate and the positively charged Apo-B moiety. Unlike therapeutic plasma exchange (TPE), LIPOSORBER® minimally affects other essential blood components, making it a highly targeted treatment.

The Mechanism of Benefit

By effectively decreasing harmful total cholesterol and LDL-C levels, LIPOSORBER® promotes several therapeutic benefits against FSGS and proteinuria:

Direct Podocyte Effects: Decreases lipotoxicity (fat-related damage) to the glomeruli (the kidney’s filtering units).
Immunologic Effects: Improves the cellular response to common medications like corticosteroids and cyclosporine.
Anti-inflammatory Effects: Removes pro-inflammatory factors, such as cytokines (e.g., IFN-gamma and IL-12), which can exacerbate kidney disease.

Potential Effectiveness: Reducing Proteinuria and Improving Renal Function

Studies suggest that treatment with LIPOSORBER® may offer significant improvements for patients with drug-resistant FSGS:

Improved Drug Response: Lipoprotein-apheresis (LA) therapy enhances corticosteroid and cyclosporine action in patients with drug resistance, likely by restoring cellular uptake and inhibiting drug efflux.

Reduced Urine Protein Levels: LIPOSORBER® therapy has induced complete or partial remission of proteinuria in up to 50% of patients with drug-resistant FSGS.

Improved Renal Function: Enabled nearly 50% of steroid-resistant primary FSGS patients to attain complete or partial remission over a two-year study duration.

Reduced Lipids in Blood: By reducing LDL-C, Lp(a), and TG, LIPOSORBER® therapy has the potential to preserve the graft and prevent the restarting of dialysis in transplant recipients.

*The content of the studies and their relevant features (e.g., LIPOSORBER or similar product, number of participants, controlled study, independent study, etc.) may be found in references 2, 4 and 6, cited below.

**Study duration took place over two (2) years.

Demonstrated Clinical Record and Approvals

LIPOSORBER® has a strong global clinical record:

It is well-tolerated by the majority of patients who receive the treatment.
Japan: Treatment for FSGS has been covered by both Public Health Insurance and Employees’ Health Insurance (EHI) since 1992.
U.S. FDA Humanitarian Use Device: Humanitarian Device Exemption (HDE) granted for use in the U.S. for nephrotic syndrome associated with primary FSGS (Note: IRB approval is required under HDE before treatment for Health Care Professionals).

Side Effects

ADVERSE EVENTS: The most common adverse events are hypotension (0.8%), nausea/vomiting (0.5%), and flushing/blotching (0.4%). Other adverse reactions include 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: Liposorber FSGS IFU

LIPOSORBER® Provides Hope When Drug Therapy Fails

LIPOSORBER® therapy offers a targeted approach for patients seeking to reduce proteinuria and improve outcomes associated with drug-resistant FSGS.

References:

Click here for LIPOSORBER Instructions for Use and safety information