Our products

Our static preservation systems, comprised of specially formulated solutions and insulated shippers, provide safe and consistent method for cold ischemic storage and transport of donor organs.

IGL-1

IGL-1® is a clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of organs (kidneys, liver, pancreas). IGL-1 solution has an osmolality of 290 mOsm/kg, a total sodium concentration of 120 mmol/L, a total potassium concentration of 25 mmol/L and a pH of 7.4 at room temperature.

Description
Product features

IGL-1® solution has the following composition :

Lactobionic acid : 35,8 g/L
Adenosine : 1,336 g/L
Allopurinol : 0,136 g/L
Glutathione : 0,922 g/L
Polyethylene glycol (PEG 35000) : 1 g/L
Potassium dihydrogen phosphate : 3,402 g/L
Raffinose pentahydrate : 17,84 g/L
Magnesium sulfate heptahydrate : 1,232 g/L
Sodium Hydroxide : qs pH : 7.4
Water for injection : qs 1 liter

PACKAGING

Transparent multi-layer bag EVA/EVOH/EVA, EVA layer in contact with solution.

IGL-1® is marketed in 1-L bags and in 2-L bags.

REGULATORY STATUS

Class III Medical device in Europe

Infos

Ensure complete flushing of blood
Decrease enzyme activity: cool the organ (hypothermic)¹
Ischaemic reperfusion damage (IRI) reduction:
1. Prevention grafts from tissue acidosis : phosphate, sulfate, and sodium hydoxide¹
2. Regeneration of high-energy substances : adenosine²
3. Prevention of oxidative damage: glutathione and allopurinol^4,5
4. Prevention of hypothermia-induced cellular swelling and oedema: PEG + membrane-impermeable substances (Raffinose & Lactobionic acid)³

The IGL-1® Solution is an extra-cellular colloid solution with polyethylene glycol (PEG) as colloid polymer.

1. F. O. Belzer and J. H. Southard, ‘Principles of Solid-Organ Preservation by Cold Storage’.
DOI 10.1097/00007890-198804000-00001.
2. F. O. Belzer and others, ‘Beneficial Effects of Adenosine and Phosphate in Kidney
Preservation’, DOI 10.1097/00007890-198336060-00008.
3. Charles Y. Lee and Martin J. Mangino, ‘Preservation Methods for Kidney and Liver’, DOI
10.4161/org.5.3.9582.
4. Richard E. Hayden and others, ‘The Effect of Glutathione and Vitamins A, C, and E on
Acute Skin Flap Survival’, DOI 10.1288/00005537-198710000-00011.
5. Beatriz Prieto-Moure and others, ‘Allopurinol in Renal Ischemia’, DOI 10.3109/
08941939.2014.911395.
6. Corinne Antoine, Régis Bronchard, Laurent Durin. ‘Protocol for Maastricht III Organ Recovery
– DGMS–DPGOT – Version n°7 November 2019’.

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