The Oxiris set has neither been cleared or approved by the FDA to treat patients with COVID-19 infection.
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for the Oxiris filter set to treat patients 18 years of age or older, who have confirmed COVID-19 infection and have been admitted to the ICU with confirmed or imminent respiratory failure in need of blood purification, including continuous renal replacement therapy (CRRT). The Oxiris set is authorized for use for no longer than the duration of the COVID-19 public health emergency, as deemed by the Secretary of the Department of Health and Human Services (HHS).
The Oxiris set is to be used with the PrisMax and PrismaFlex systems, and is the only filter that performs both blood purification therapies simultaneously, including continuous renal replacement therapy (CRRT) and the removal of endotoxins and inflammatory mediators from the blood.
The needs of patients in the Intensive Care Unit (ICU) are often complicated. In severe cases of COVID-19 infection, patients may develop acute kidney injury (AKI) or have high levels of inflammatory mediators circulating in the blood. Either of these conditions can be life-threatening and requires intervention.
The Oxiris filter set has a three-layer membrane structure:
- The enhanced AN69 membrane enables adsorption of cytokines and toxins while providing renal support by diffusion and convection.
- The PEI (polyethyleneimine) surface treatment allows for the adsorption of endotoxins.
- The heparin graft on the membrane reduces membrane thrombogenicity.
Intended Use Information
The Oxiris Set is indicated for use only with the Prismaflex or PrisMax control unit.
The Oxiris Set is authorized by FDA under an Emergency Use Authorization (EUA) for the treatment of patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure in need of blood purification, including use in continuous renal replacement therapy, to reduce pro-inflammatory cytokine levels, who have any one of the following conditions:
- Early acute lung injury (ALI)/ early acute respiratory distress syndrome (ARDS)
- Severe disease, defined as:
- Respiratory frequency ≥ 30/min,
- Blood oxygen saturation ≤ 93%,
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300,and/or
- Lung infiltrates >50% within 24 to 48 hours
3. Life-threatening disease, defined as:
- Respiratory failure,
- Septic shock, and/or
- Multiple organ dysfunction or failure
Important Risk Information
The use of Oxiris is contraindicated (as mentioned in the IFU) when:
• Patients present a known allergy to heparin or have type II thrombocytopenia caused by heparin (HIT Syndrome type II)
• A drug used simultaneously with Oxiris is contraindicated per its Instructions for use
Relative contraindications (individual risk/benefit to be determined by treating physician) for the use of Oxiris include:
• The inability to establish vascular access to safely perform CRRT / hemoperfusion (SCUF; CVVH; CVVHD; CVVHDF)
• Severe hemodynamic instability
• Known hypersensitivity to any component of the Oxiris Set
This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.
All treatments administered with the Oxiris Set must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
RX Only. For safe and proper use of the products mentioned herein, please refer to the Operator's Manual or Instructions for Use.