Alteco® LPS Adsorber

I n n o v a t i o n & E x p e r i e n c e

The new option for your septic patients

SOFA scores (n=5)(SCORE)

SAMPLINGPOINTS**

P. 1

P. 2

P. 3

P. 4

P. 5

1 2 3

14

12

10

8

6

4

2

01 3 542

0.6

0.5

0.4

0.3

0.2

0.1

0

Duration of NA infusion (n=5)

SAMPLINGPOINTS***

P. 1

P. 2

P. 3

P. 4

P. 5

(ug/kg/min)

TREATMENT 1 TREATMENT 2

Mean LPS values (n=7)(EU/ml)

SAMPLINGPOINTS*

Mean values

1 2 3 4 5

2.0

1.8

1.4

1.2

1.6

1.0

0.8

0.6

0.4

0.2

0

TREATMENT 1 TREATMENT 2

Mean Dopamine administration (n=7)(ug/kg/min)

SAMPLINGPOINTS*

Mean values

1 2 3 4 5

16

12

14

10

8

6

4

2

0

Study 1

Study 2

...with outcomes that make a difference

Treatment with the Alteco® LPS Adsorber has been reported to reduce levels of LPS and sepsis markers such as procalcitonin, TNF-alpha and interleukins, and also to improve hemodynamic paramenters4-5. For patients with septic shock, rapid reduction of the vasopressor dose and quick reversal of septic shock has also been demonstrated4-6.

No side effects or hypersensitivity reactions due to the use of the product are known7.

Mean LPS concentrations in blood and dopamine doses in 7 patients with severe gram-negative sepsis and septic shock are shown in the graphs below5. The patients were treated twice with the Alteco® LPS Adsorber. Each treatment lasted approximately 120 min and the periods between treatment were approximately 24 hours.

* 1. Prior to 1st treatment 2. 5 min after 1st treatment 3. 6 hours after 1st treatment 4. Before start of 2nd treatment 5. 5 min after 2nd treatment

SOFA scores and duration of vasopressor treatment for five patients with abdominal septic shock treated once with the Alteco® LPS Adsorber are shown below4. The average decrease in SOFA scores from baseline to 24 hours post treatment was was 3.4 ± 1.7 (-2 to -6) points. The mean total duration of NA infusion was 46 hours shorter in the adsorber group compared to 10 matched historical controls (95% CI - 104 h to 12 h, p = 0.165).

** 1. Prior to treatment 2. After treatment 3. 24 hours after treatment *** 1. Prior to treatment 2. After treatment 3. 6 hours after treatment 4. 12 hours after treatment 5. 24 hours after treatment

By using the Alteco® LPS Adsorber

you can safely and successfully treat

your patients with gram-negative

severe sepsis or septic shock.

This unique medical device is based

on advanced biotechnology and

selectively adsorbs endotoxin (LPS)

from whole blood.

New capturing technology...

Alteco® LPS Adsorber

I n n o v a t i o n & E x p e r i e n c e

Sepsis - a therapeutic dilemma

Sepsis is a complex and dreaded disease with high incidence and mortality. It is defined as the body's response to an infection, i.e. a verified or suspected infection in combination with a whole body inflammatory state called SIRS (systemic inflammatory response syndrome).

Sepsis is mainly developed during hospital stays and remains a therapeutic dilemma despite advances in drug therapy and intensive care. Sepsis is a major cause of morbidity and mortality in intensive care clinics and the incidence, as well as the costs, is continuously increasing.

Today, several millions of patients worldwide suffer from severe sepsis/septic shock every year1, with estimated mortality rates of over 30 % for patients with severe sepsis and over 50 % for patients with septic shock2.

Endotoxins- the mediators

Endotoxins, or lipopolysaccharides (LPS), are major components of cell membranes of gram-negative bacteria. LPS is well known to induce a strong response from the immune system leading to release of inflammatory mediators and occasionally sepsis, or even septic shock.

Endotoxins are large molecules consisting of a lipid part, called Lipid A, and a polysaccharide chain. These are joined by a covalent bond. The polysaccharide chain varies greatly between different bacteria strains, while the Lipid A part is invariable.

Lipid A, which is responsible for the toxic effects, is exposed when the bacteria are lysed, and the inflammatory cascade is then initiated.

High levels of endotoxins have been demon-strated not only in patients with gram-negative infections, but also in trauma patients, patients with severe burn injuries, patients after major surgery and also in patients with gram-positive infections3.

The Alteco® LPS Adsorber in an extracorporeal circuit for treament of a patient with gram-negative septic shock.

Schematic figure showing the three main parts of the lipopolysaccharide molecule.

Endotoxin

O-antigen

Core Polysaccharide

Lipid A

Fatty Acids

Glucosamine

Alteco® LPS Adsorber- a targeted therapy

• For whole blood• Adsorbs LPS selectively• Non-toxic

The Alteco® LPS Adsorber is a Class IIa medical device for extracorporeal removal of LPS from whole blood. The product does not contain any pharmaceuticals or toxic components. The device consists of a housing filled with porous plates of polyethylene. Since the plates are rigid there is no compliance in the product. A tailor-made peptide with high affinity for LPS is bound to the surface of the porous plates by covalent bindings. During treatment, the peptide captures LPS from the patient’s blood stream.

The peptide used is synthetic and non-toxic. Its high affinity to the Lipid A moiety of the endotoxin molecule ensures efficient reduction of endotoxins from different bacteria species since this part of the LPS molecule is constant.

Easy to set up - Easy to useThe Alteco® LPS Adsorber is a stand alone product aimed for hemoperfusion of whole blood.

The product is very easy to set up and use. A blood pump aimed for hemoperfusion, blood lines with standard dialysis connectors and equipment for blood access, and an air trap are required for treatment.

The ProcedureAlteco® LPS treatment should be started as soon as possible and preferably no later than 36 hours after onset of septic shock. Before use, the Alteco® LPS Adsorber must be rinsed with NaCl solution and primed with NaCl solution containing heparin. Set-up and priming take approximately 15 minutes. Anticoagulation of the patient using heparin is also needed. The adsorber is then connected to the patient’s vascular access for veno-venous hemo-perfusion using a continuous blood flow rate of 150 ± 50 ml/min for approximately 120 minutes. In cases when the condition of the patient is still severe and/or the patient still requires vasopressor treatment 24 hours after the first adsorber treatment, a second adsorber treatment is recommended.

NOTE: For complete information on the use of the Alteco® LPS Adsorber, please refer to the Instructions for Use.

Blood pump

Alteco® LPS Adsorber

Air trapThe cationic peptides are attachedto the PE-discs by covalent connection technique. During treatment the cationic part of the peptides captures the negatively charged endotoxin molecules.

LPS capturing principle

Pore in PEPore size: 100 micron

PE SurfaceEndotoxin (LPS)

Cationic peptide

References1) Source: Surviving Sepsis campaign: www.survivingsepsis.org.

2) Vincent JL. et al. Sepsis in European intensive care units: Results of the SOAP study. Crit Care Med 2006; 34(2):344-353.

3) Danner R. et al. Endotoxemia in Human Septic Shock. Chest 1991 Jan;99(1):169-75.

4) Ala-Kokko T. LPS Adsorber in abdominal septic shock. Abstract no. 305 ESICM 2009 Brussels, Belgium.

5) Kulabukhov V. The Use of a novel technique for adsorption of lipopolysaccharide in the combined treatment of patients with severe gram negative sepsis. Abstract no. 78 Sepsis 2008: An international sepsis symposium, Paris, France.

6) Kulabukhov V. Use of an endotoxin adsorber in the treatment of severe abdominal sepsis. Acta Anaesthesiol Scand. 2008 Aug;52(7):1024-5.

7) Blomquist S. et al. Clinical experience with a novel endotoxin adsorption device in patients undergoing cardiac surgery. Perfusion 2009;24: 13-17.

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Information Box

Alteco® LPS Adsorber

Treatment Data Rinsing: 500 ml 0.9 % NaCl

Priming: 0.9 % NaCl solution with heparin

Blood priming volume: 20 ml

Adsorption capacity: > 7500 Endotoxin Units

Blood flow, recommended: 150 ± 50 ml/min,

continuous flow

ACT (Activated Clotting Time): > 180 s

Pressure drop at 100 ml/min: ~ 23 mm Hg

Pressure drop at 200 ml/min: ~ 50 mm Hg

Recommended treatment time: 2 hours

Maximum treatment time: 6 hours

Product SpecificationHousing: Polycarbonate

End caps: Polycarbonate

Matrix (porous plates): Polyethylene

Active component: Peptide (100 % synthetic)

Sterilisation: Radiation (e-beam)

Expiration time: 3 years

Inlet/outlet connectors: Standard dialysis

connectors

Storage temperature: + 5 °C to + 30 °C

Packaging and storage: The product is delivered dry in a

sterile pouch and packed in a box

and carton which must be stored

in a cool and dark place.

Regulatory InformationProduct registration: ~ 30 countries around the world

Notified body: Lloyd´s RQA

Classification: Medical Device, Class IIa

ISO certificate: ISO 13485

Dimensions and WeightLength: 135 mm

Outer diameter: 52 mm

Net weight: ~ 260 g

Order InformationProduct name: Alteco® LPS Adsorber

Product reference number: LPS-33-100-46

Developer & Manufacturer: Alteco Medical AB

Alteco® is a registered trademark of Alteco Medical AB.The Alteco® LPS Adsorber is based on technology for which patents have been granted in the EU, China (PRC), Russia, USA, etc. The product is bar-coded according to

GTIN-13. Not for sale in the US.