Efferon® LPS

Next-generation extracorporeal blood adsorber, non-pyrogenic, gamma-sterilized, single-use medical device. Selective adsorption of lipopolysaccharides and non-selective adsorption of cytokines, myoglobin, cellular debris, endogenous and exogenous toxic substances.
INDICATIONS
  • Sepsis of verified or suspected gram-negative aetiology, including septic shock.
  • Elevated levels of endotoxin in blood, critical endotoxemia.
  • Elevated levels of cytokines in blood, “cytokine storm” syndrome.

Intended use

Device is intended for extracorporeal blood purification via hemoperfusion in extracorporeal circuit. It can be used in direct hemoperfusion mode or in combination with RRT, ECMO and CPB. Inflammatory mediators and endotoxin are removed from patients’ circulation. Timely administration improves vital functions and hinders progression of multiple organ failure in sepsis patients.

Instruction for use

Lipopolysaccharide Adsorption at Septic Shock (LASSO) – multicenter randomized clinical study

Study design: Patients with abdominal sepsis, complicated with septic shock, were randomly divided in two subgroups. Patients in intervention subgroup were subjected to first Efferon® LPS hemoperfusions in <12 hours since onset of septic shock and second Efferon® LPS hemoperfusion in 24 hours since start of the first one. Median duration of hemoperfusions were 5.5 hours. Patients in control group received standard of care treatment without extracorporeal removal of endotoxin or inflammatory mediators.

Study conclusions:

Efferon® LPS hemoperfusion yielded significant improvements of vital functions and survival rate in patients with septic shock.

  1. Hemodynamics: increase of mean arterial blood pressure accompanied with decreased requirements to vasopressor and inotropic drugs (starting in 24 hours);
    shorter duration of septic shock among surviving patients (57 hours in Efferon® LPS vs 101 hours in control group);
    septic shock successfully resolved in 68% patients in Efferon® LPS group vs 40% in control group.
  2. Respiratory function: shorter duration of invasive mechanical ventilation in surviving patients (2.6 days in Efferon® LPS vs 4.8 days in control group)
    higher chance of successful weaning from invasive mechanical ventilation (57% in Efferon® LPS vs 29% in control group)
    increase of PaO2/FiO2 oxygenation index (starting in 24 hours).
  3. Renal function: lower serum creatinine (starting in 72 hours);
    shorter duration of renal replacement therapy.
  4. Multiple Organ Failure Syndrome: lower SOFA score in Efferon® LPS hemoperfusion group (starting in 24 hours)
  5. Inflammatory biomarkers: Efferon® LPS hemoperfusion decreased levels of abnormally elevated serum procalcitonin, C-reactive protein, interleukin-6, leukocytes and neutrophils count. 75% patients responded with decrease of endotoxin levels in blood.

Polymeric adsorbent
Efferon® LPS.
Mode of action

Multimodal adsorbent selectively binds two dissimilar therapeutic targets – bacterial endotoxins (PAMP molecules) and excessive cytokines (DAMP molecules).
Cytokines are bound by intrinsic porosity of polymeric scaffold.
Endotoxin is bound due to interaction with surface-immobilized LPS-selective ligand.

How does it work?

Ready to use, sterile and pyrogen-free

Low flow resistance, uniform flow

Tough polycarbonate column

Standard dialysis connectors for perfusion machines

Simple and reliable design eliminates connection errors

Contains suspension of spherical adsorbent beads in isotonic sodium chloride solution

Firm and stable polymer,
does not crumble or dustNo organic impurities emissionHigh hemocompatibility, low thrombogenic activityMesoporous structure adsorbs excess of cytokines, myoglobin and other inflammatory mediatorsDoes not adsorb albumin or larger plasma proteins

LPS selective synthetic ligandCovalent immobilization, no residual emission

Irreversible LPS binding, prolonged effective duration of hemoperfusion

Specification

Polymeric adsorbent

Macroporous hypercrosslinked styrene-divinylbenzene copolymer with immobilized LPS-selective ligand, suspension in saline

Total internal volume

210 ml

Adsorbent volume

190 ml

Blood filling volume

50-100 ml

Recommended blood flow rate through the device

100-300 ml/min

Construction

Symmetrical polycarbonate cylinder with two end filters, O-rings and side covers with screw caps

Weight

350 g

Diameter × length

6 × 22 cm

Individual packing

PE / PA bag

Sterilization

radiation sterilization

Efferon® LPS

Single-use therapeutic device for extracorporeal blood adsorption. Contains polymeric beads surface-modified with LPS-selective ligand.

Efferon® CT

Single-use therapeutic device for extracorporeal blood adsorption. Contains anti-cytokine polymeric beads.

Contact us

Find out more
about Efferon®

mail@efferon.com

Efferon GmbH
60489, Germany, Frankfurt am Main
Westerbachstraße 47

Efferon OÜ
10613, Estonia, Tallinn
Mooni tn 18