LIGASORB®

Highly selective single-use IgG adsorber

LIGASORB®

LIGASORB® is a selective single-use, multiple-pass IgG adsorber for intervening in the acute exacerbation of autoimmune diseases1

LIGASORB® offers flexible therapy schemes for acute episodes of antibody driven diseases.

 

Flexible therapy schemes

LIGASORB® offers full flexibility where therapy schemes only require a few treatment sessions, as is the case in acute episodes of the following antibody driven diseases:

Neurology

  • Myasthenia gravis2
  • Guillain-Barré syndrome3
  • Corticoid-resistant multiple sclerosis4
  • Neuromyelitis optica5

Dermatology

  • Bullous pemphigoid6
Antibody driven diseases

Single use, but regenerable

LIGASORB® is the first Fresenius Medical Care adsorber that can be regenerated during ongoing therapy (multiple-pass) but disposed of after one treatment session (single-use).

In contrast to therapeutic plasma exchange, only a small amount of other essential plasma components (such as albumin) are removed during immunoadsorption.

LIGASORB use in ongoing therapy
LIGASORB® use in ongoing therapy (multiple-pass).

Efficient IgG reduction

Due to its highly selective protein A ligand and regeneration capabilities, LIGASORB® is able to process up to six litres of plasma and remove up to 20 grams of IgG in a single treatment session.

The total IgG reduction after three treatment sessions is 86% (mean value)7.

LIGASORB Clinical Evaluation
Source: Internal data (non-published), LIGASORB Clinical Evaluation report, 2015 Fresenius Medical Care7

LIGASORB® — Safety features

  • Daily treatments are possible due to its minimal removal of essential endogenous substances7
  • Limited fibrinogen reduction (mean value 17%) with fast recovery after approx. one week7
  • Minimal activation of complement factors and fast recovery of albumin levels8
  • No need to substitute with albumin or fresh frozen plasma and therefore low risk of side effects (e.g., anaphylactic reactions) usually associated with transfusions of blood products9
[Translate to English (MEA):] LIGASORB Clinical Evaluation
[Translate to English (MEA):]

Source: Internal data (non-published), LIGASORB Clinical Evaluation report, 2015 Fresenius Medical Care7

Clinical setup

  • A clinical setup requires the COM.TEC® device, a centrifuge for plasma separation and the ADAsorb® machine for column management.
  • As an alternative to the COM.TEC® device, the Art Universal filtration device could be used to obtain plasma.
LIGASORB Clinical setup
LIGASORB® Clinical setup

Related therapies

1. Instructions for use (IFU) LIGASORB®, Art. no. F00001564, 35840318 / 3 - 04/2016.
2. Köhler et al, Journal of Clinical Apheresis Dec. 2011; 26(6): 347–55.
3. Seta et al, Clinical Neurology and Neurosurgery Oct. 2005; 107(6): 491–6.
4. Heigel et al, Atherosclerosis Supplements Jan. 2013; 14(1): 167–73.
5. Collongues et al, Therapeutic Advances in Neurological Disorders Mar. 2011; 4(2).
6. Kasperkiewicz et al, Journal of the American Academy of Dermatology Nov. 2014; 71(5): 1018–20.
7. Internal data (unpublished), LIGASORB Clinical Evaluation report, 2015 Fresenius Medical Care.
8. Internal data (unpublished), Study Report, 27 March 2015, Fresenius Medical Care.
9. Alarabi et al, Artificial Organs Sep. 1993; 7(9): 782–6.