Healthcare professional interacts with the PrisMax system with a TPE filterset attached to it

Therapeutic Plasma Exchange

An extracorporeal blood purification technique designed for the removal of large molecular weight substances.¹

First-line treatment for multiple diseases

Therapeutic plasma exchange (TPE) is associated with positive improvement in clinical outcomes in the treatment of Guillain-Barré syndrome, thrombotic thrombocytopenic purpura (TTP), myasthenia gravis and Goodpasture syndrome and is recommended as a first-line therapy* for these conditions in guidelines from the American Society for Apheresis (ASFA).²

The goal of TPE is to remove and/or treat diseased blood components.

* Recommended as first-line therapy, either as the primary standalone treatment or in conjunction with other modes of treatment, for certain indications of Goodpasture syndrome, myasthenia gravis, and other diseases noted above.

Autoimmune: Goodpasture syndrome Autoimmune neurologic: Guillain-Barré syndrome, Myasthenia gravis Immune: Hyperviscosity in hypergammaglobulinemia Hematologic: Thrombotic thrombocytopenic purpura (TTP)

How TPE works

During apheresis therapy, a component of the blood that is abnormal and causing illness is removed, while the healthy, normal components are returned to the patient.

TPE is a type of apheresis therapy where plasma is removed through the large pore membrane of the plasma filter, while fresh plasma or other types of colloid solutions are infused post plasma filter to replace the plasma removed. TPE is designed for the removal of large molecular weight substances such as pathogenic auto-antibodies, immune complexes, cryoglobulins and more.¹

There are two fundamentally different technological approaches to achieve plasma exchange: plasma separation with centrifugal forces, and separation with a filter membrane-based apparatus. They operate on different physical principles, but each is capable of efficiently fractionating plasma contents from whole blood and allowing for replacement with plasma or albumin.

TPE is associated with positive improvement in clinical outcomes

Guillain-Barré syndrome

Several controlled trials indicate that TPE can accelerate motor recovery, decrease time on the ventilator and speed of attainment of other clinical milestones compared with supportive care alone.²

Thrombotic thrombocytopenic purpura

TPE has decreased overall mortality of immune-mediated TTP from nearly uniformly fatal to <10-20%.²

Myasthenia gravis

TPE in myasthenia gravis works rapidly. Clinical effect can be apparent within 24 hours of treatment; however, in some cases it may take a week. Concomitant immunosuppression must be initiated or modified for sustained control of myasthenia gravis activity.²

Anti-glomerular basement membrane disease (Goodpasture syndrome)

A randomized controlled trial involving a small number of patients showed that TPE maintained kidney function and improved survival.²

ASFA guidelines

The American Society for Apheresis (ASFA) publishes comprehensive guidelines for therapeutic apheresis. The ASFA evidence-based approach assigns diseases to categories based on a stringent review of the literature, analysis of quality of evidence and strength of recommendation derived from the evidence.

Comprehensive guidelines for therapeutic apheresis

Important Safety Information

The PrisMax control unit is intended for:

Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kg or more with acute renal failure and/or fluid overload.
Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kg or more with diseases where removal of plasma components is indicated.

All treatments administered via the PrisMax control unit must be prescribed by a physician.

Rx Only. For safe and proper use of the products mentioned herein, please refer to the appropriate Operator’s Manual or Instructions for Use.

Vantive and PrisMax are trademarks of Vantive Health LLC or its affiliates.

References

Kaplan AA. Therapeutic plasma exchange: core curriculum 2008. Am J Kidney Dis. 2008;52(6):1180-1196.
Padmanabhan A, Connelly-Smith L, Aqui N, et al. Guidelines on the use of therapeutic apheresis in clinical practice — evidence-based approach from the Writing Committee of the American Society for Apheresis: the eighth special issue. J Clin Apher. 2019;34(3):171-354.
Schwartz J, Padmanabhan A, Aqui N, et al. Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue. J Clin Apher. 2016;31(3):149-162.