Next-generation pediatric extracorporeal blood adsorber, non-pyrogenic, gamma-sterilized, single-use therapeutic device. Selective adsorption of lipopolysaccharides and non-selective adsorption of cytokines, myoglobin, cellular debris, endogenous and exogenous toxic substances. First multimodal hemoadsorption device approved for use in neonatal and pediatric patients with sepsis and septic shock. The certification is supported by results of the multicenter LASSO NEO study (NCT05707494), which for the first time demonstrated the clinical efficacy of targeted endotoxin and cytokine removal in children.
The device is approved for children below 18 years old.
Device is intended for extracorporeal blood purification via hemoperfusion in extracorporeal circuit in pediatric patients. 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.
The study included 78 patients aged from 1 month to 14 years (32 Efferon NEO + 46 control) who were enrolled across 8 study centers.
Key results:
● The primary endpoint was achieved. The multiple organ failure score (pSOFA) was significantly lower in patients who received hemoadsorption: 4.9 vs. 7.8 in the control group (p = 0.006) on day 7,
● Patients in the hemoadsorption group were weaned off mechanical ventilation (p = 0.003) and vasopressor support (p = 0.001) faster,
● Patients treated with hemoadsorption using Efferon NEO showed a significant reduction in inflammatory markers (CRP, IL-6, TNF-α; p < 0.05), providing a mechanistic explanation for the observed results.
The 28-day mortality rate was 9% in the Efferon NEO group compared to 35% in the control (p = 0.008, OR = 0.2).
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
Selective synthetic ligand
Covalent immobilization, no residual emission
Irreversible endotoxins binding, prolonged effective duration of hemoperfusion
Polymeric adsorbent
Macroporous hypercrosslinked styrene-divinylbenzene copolymer with immobilized selective ligand, suspension in saline
Inner volume
60 ml
Blood filling volume
30 ml
Recommended blood flow rate through the device
3 – 7 mL/min per kg of body weight of the patient
Construction
Symmetrical polycarbonate cylinder with two end filters, O-rings and side covers with screw caps
Weight
130 g
Diameter × length
51*134 mm
Individual packing
PE / PA bag
Sterilization
radiation sterilization
Common risks
Potential side effects
