Oxiris set

Oxiris is the ONLY blood purification filter set to effectively remove inflammatory mediators, endotoxin, fluid, and uremic toxins SIMULTANEOUSLY^1-5

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Sepsis is a major and growing global healthcare challenge.^6-8 Blood purification therapies may help improve outcomes.^1,3,9-11

~30%of ICU patients have sepsis¹²

~50% of patients with sepsis have kidney dysfunction or failure^13,14

~45% of patients with sepsis die within 1 year^7,8,15

The ICU is a complex environment. What if you were equipped with powerful simplicity?

VERSATILE INNOVATION The Oxiris set can be used to deliver hemoperfusion to reduce elevated levels of inflammatory mediators/endotoxin and/or to deliver any CRRT modality (SCUF, CVVH, CVVHD, CVVHDF) to provide uremic toxin removal and support fluid management.⁵

Note: CVVH, Continuous Veno-Venous Hemofiltration; CVVHD, Continuous Veno-Venous HemoDialysis; CVVHDF, Continuous Veno-Venous HemoDiaFiltration ; SCUF, Slow Continuous UltraFiltration

INFLAMMATORY MEDIATOR REMOVAL A prospective, multicenter, observational study reported a significant decrease from baseline in serum IL-6 levels in patients with COVID-19 treated with the Oxiris set.²

ENDOTOXIN REMOVAL A randomized, crossover study reported significantly greater changes from baseline in endotoxin level with the Oxiris set, compared to the AN69 ST filter set in patients with septic shock-associated AKI.³

VERSATILE SIMPLIFICATION The Oxiris filter set is designed to simplify BP therapy delivery for patients requiring both cytokine/endotoxin removal and CRRT, which may free up nursing time.

The Oxiris set is part of a pre-connected set for simplicity. The closed system includes a filter membrane pre-connected to the color-coded tubing, minimizing set-up steps and reducing potential for touch contamination.^5,16

The Oxiris set can play a role in the management of patients with severe COVID-19

In a prospective observational pilot study of COVID-19 patients (n=37) admitted to an ICU in Italy between February and April 2020, patients were treated with extracorporeal blood purification (EBP) using the Oxiris set for immunomodulation and/or support to renal function during AKI.²

Results suggest that early initiation of EBP during COVID-19 may be associated with greater benefits.

^{* IL-6 reduction was statistically significant over the first 72 hours of treatment (p<0.001), and for each time period (24h, 48h, 72h) compared to baseline (p=0.001). p<0.016 considered for statistical significance.}

^{† Sequential Organ Failure Assessment.}

^{‡ SOFA score reduction was statistically significant over the first 72 hours of treatment (p=0.002), and at 48h vs baseline (p=0.001) and 72h vs baseline (p=0.002). p<0.016 considered for statistical significance.}

^{§ Due to the observational design of this study (single arm without active control group), it was not possible to determine whether a causal relationship exists between EBP with Oxiris and improvement in patient outcomes (organ function or mortality). Given the small number of patients studied, it was not possible to identify any parameter values or illness stage that might indicate a threshold or cutoff for the best time to initiate EBP.}

^{¶ Acute Physiological and Chronic Health Evaluation (APACHE) is a scoring system for disease severity that uses actual clinical data obtained on the first day of ICU admission to estimate the risk of short-term mortality as well as predict the length of ICU stay.}

See how in a webinar facilitated by Dr. Gianluca Villa.

About “Extracorporeal Blood Purification therapies in COVID-19 patients, exploring the rationale and global acute RRT experience.”

Watch webinar

Oxiris is the ONLY blood purification filter set to effectively remove inflammatory mediators, endotoxin, fluid, and uremic toxins SIMULTANEOUSLY^1-5

Unique membrane technology provides a 3-fold mode of action^17-19

A: Heparin coating: pre-coating the membrane with heparin reduces the thrombogenicity of the polyethyleneimine (PEI) coating
B: PEI surface treatment: adsorbs endotoxin
C: AN69 base membrane: adsorbs cytokines and toxins while providing continuous renal support. Cytokine adsorption occurs throughout the entire membrane thickness

How the unique membrane technology works

Explore the clinical data

Evidence suggests that the Oxiris set is associated with clinical improvement in organ function (as measured by SOFA score) and hemodynamic parameters^1,3,23,24

Access clinical data

Endotoxin and cytokine removal with the Oxiris filter set in vivo

A retrospective observational case series of patients with sepsis treated with CRRT using Oxiris set reported decreases from baseline in levels of pro- and anti-inflammatory cytokines (IL-6, IL-10) and other markers of infection (procalcitonin levels and endotoxin activity).1 The change from baseline in immunologic parameters to the end of treatment with Oxiris set (74 ± 36 hours) is shown to the left.^a

a Change from baseline to the end of treatment (74 ± 36 hours) in endotoxin activity (0.74 ± 0.15 to 0.58 ± 0.18), IL-6 (506 ± 400 to 126 ± 92 pg/mL, P < 0.001), IL-10 (106 ± 57 to 28 ± 17 pg/mL, P < 0.05), and procalcitonin (30 ± 36 to 8 ± 9 ng/mL, P < 0.05).

The COVID-19 pandemic

Systemic inflammation in patients with COVID-19 can lead to multi-organ failure, including AKI.^20,21
Blood purification techniques have been shown to remove cytokines, endotoxin, and circulating viral particles in patients with COVID-19.²²
Blood purification is the only therapy that may effectively remove inflammatory mediators, damage-associated molecular patterns (DAMPs), and/or pathogen-associated molecular patterns patterns (PAMPs, e.g., endotoxin),2 which may help mitigate progression to multi-organ failure.^{1,2,9,11,23-25}

Potential targets for COVID-19 therapies include the removal of cytokines²⁷

Potential_targets_COVID-19_therapies — Stages of the SARS-CoV-2 life cycle offer potential treatment targets. Potential targets for COVID-19 therapies include anti-inflammatory therapies²⁹, prevention of membrane fusion and viral cell entry²⁶, removal of cytokines or prevention of cytokine receptor activation^26-28, and prevention of RNA translation.^26,30-33

Related Products and Therapies

IMPORTANT SAFETY INFORMATION⁵

The Oxiris set is a disposable, extracorporeal circuit for use with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
The Oxiris set is indicated for use in critically ill patients with a body weight equal or greater than 30 kg (66lb) for hemoperfusion and / or renal replacement modalities such as:
• Slow Continuous UltraFiltration (SCUF)
• Continuous Veno-Venous Hemofiltration (CVVH)
• Continuous Veno-Venous HemoDialysis (CVVHD)
• Continuous Veno-Venous HemoDiaFiltration (CVVHDF)

When used for hemoperfusion only, the SCUF mode shall be used with no fluid removal prescription, as the indication is to reduce elevated levels of inflammatory mediators, such as cytokines, and to reduce endotoxins.
If patients suffer from acute kidney injury and / or volume overload, the Oxiris set is indicated for continuous renal replacement therapies (CRRT), to perform fluid management and removal of uremic toxins. The removal of inflammatory mediators and endotoxins is performed simultaneously when indicated for CRRT.

For safe and proper use of the products mentioned herein, please refer to the Operator’s Manual or Instructions for Use.

_{Oxiris set}

See References

Turani F, et al. Blood Purif. 2019; 47(Suppl. 3):54–58.
Villa G, et al. Crit Care. 2020; 24:605.
Broman ME, et al. PLoS One. 2019; 14:e0220444.
Malard B, et al. Intensive Care Med Exp. 2018; 6:12.
Baxter. Oxiris Instructions for Use. 2022.
Rudd KE, et al. Lancet. 2020; 395:200-211.
Karlsson S, et al. Intensive Care Med. 2007; 33:435-443.
Van Vught L, et al. JAMA. 2016; 315:1469-1479.
Lumlertgul N & Srisawat N. Int J Artif Organs. 2020; 44:17–24.
Cruz DN, et al. JAMA. 2009; 301:2445–2452.
Hawchar F, et al. J Crit Care. 2019; 49:172–178.
Sakr Y, et al. Open Forum Infect Dis. 2018; 5:ofy313
Yébenes JC, et al. Ann Intensive Care. 2017; 7:19.
Mayr FB, et al. JAMA. 2010; 303:2495-2503.
Prescott HC, et al. BMJ. 2016;353:i2375.
Baxter. Oxiris Specification Sheet. 2022.
Monard C, et al. Blood Purif. 2019; 47(Suppl. 3):2–15.
Thomas M, et al. Contrib Nephrol. 2011; 173:119–129.
Hattori N & Oda S. Ren Repl Ther. 2016; 2:41.
Lavillegrand JR, et al. Ann Intensive Care. 2021; 11:9.
Anderberg SB, et al. Cytokine. 2021; 138:155389
Nadim MK, et al. Nat Rev Nephrol. 2020; 16:747–764.
Schwindenhammer V, et al. Blood Purif. 2019; 47:29–35.
Nassiri AA, et al. Artif Organs. 2021; 45:1338–1347.
Rosalia RA, et al. Blood Purif. 2021; 51:233–242.
Sanders JM, et al. JAMA. 2020; doi: 10.1001/jama.2020.6019.
Ronco C, et al. Blood Purif. 2020; doi: 10.1159/000508125.
Huet T, et al. Lancet Rheumatol. 2020; 2: e393–400.
RECOVERY. N Engl J Med. 2020; doi: 10.1056/NEJMoa2021436.
Hung IF-N. Lancet 2020; 395: 1695–704.
Sang P, et al. RSC Advances. 2020; 10:15775.
Beigel JH, et al. N Engl J Med. 2020; doi: 10.1056/NEJMoa2007764.
U.S. National Library of Medicine. NCT04351295. Available at: https://clinicaltrials.gov/ct2/show/NCT04351295 (accessed November 2021).

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Oxiris set

Sepsis is a major and growing global healthcare challenge.^6-8 Blood purification therapies may help improve outcomes.^1,3,9-11

~30%of ICU patients have sepsis¹²

~50% of patients with sepsis have kidney dysfunction or failure^13,14

~45% of patients with sepsis die within 1 year^7,8,15

The ICU is a complex environment. What if you were equipped with powerful simplicity?

The Oxiris set can play a role in the management of patients with severe COVID-19

See how in a webinar facilitated by Dr. Gianluca Villa.

Oxiris is the ONLY blood purification filter set to effectively remove inflammatory mediators, endotoxin, fluid, and uremic toxins SIMULTANEOUSLY^1-5

How the unique membrane technology works

Explore the clinical data

Endotoxin and cytokine removal with the Oxiris filter set in vivo

The COVID-19 pandemic

Potential targets for COVID-19 therapies include the removal of cytokines²⁷

Related Products and Therapies

IMPORTANT SAFETY INFORMATION⁵

Sepsis is a major and growing global healthcare challenge.6-8 Blood purification therapies may help improve outcomes.1,3,9-11

~30%of ICU patients have sepsis12

~50% of patients with sepsis have kidney dysfunction or failure13,14

~45% of patients with sepsis die within 1 year7,8,15

The ICU is a complex environment. What if you were equipped with powerful simplicity?

The Oxiris set can play a role in the management of patients with severe COVID-19

See how in a webinar facilitated by Dr. Gianluca Villa.

Oxiris is the ONLY blood purification filter set to effectively remove inflammatory mediators, endotoxin, fluid, and uremic toxins SIMULTANEOUSLY1-5

How the unique membrane technology works

Explore the clinical data

Endotoxin and cytokine removal with the Oxiris filter set in vivo

The COVID-19 pandemic

Potential targets for COVID-19 therapies include the removal of cytokines27

Related Products and Therapies

PrisMax 2

PrisMax

Blood Purification

IMPORTANT SAFETY INFORMATION5

Sepsis is a major and growing global healthcare challenge.^6-8 Blood purification therapies may help improve outcomes.^1,3,9-11

~30%of ICU patients have sepsis¹²

~50% of patients with sepsis have kidney dysfunction or failure^13,14

~45% of patients with sepsis die within 1 year^7,8,15

Oxiris is the ONLY blood purification filter set to effectively remove inflammatory mediators, endotoxin, fluid, and uremic toxins SIMULTANEOUSLY^1-5

Potential targets for COVID-19 therapies include the removal of cytokines²⁷

IMPORTANT SAFETY INFORMATION⁵