oXiris set - India CDSCO Medical Device Registration

Product Information

Intended Purpose: The oXiris set is a single use device that provides blood purification via diffusion, convection and adsorption through a semipermeable membrane. The oXiris set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit ##PLACEHOLDER_0##. 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. It is intended for use in critically ill COVID19 patients in need of blood purification where excessive inflammatory mediators are present i.e. cytokine storm release. Considerations for eligibility of oXiris use: suspected or confirmed COVID19, early acute lung injury ALI, early acute respiratory distress syndrome ARDS, cytokine storm release, Severe disease such as dyspnea respiratory frequency greater than equal to 30 per min blood oxygen saturation less than equal to 93 percent partial pressure of arterial oxygen to fraction of inspired oxygen ratio greater than 300 and or lung infiltrates on radiographic imaging, fife threatening disease such as respiratory failure and or septic shock and or multiple organ dysfunction or failure, presence of excessive endotoxin. Only for the duration that circumstances of pandemic ##PLACEHOLDER_0## exist without making changes to already approved Instruction for Use. Indications: The oXiris set is indicated for use in critically ill patients with a body weight equal or greater than 30 kg ##PLACEHOLDER_0## for hemoperfusion and / or renal replacement modalities such as: • Slow Continuous UltraFiltration ##PLACEHOLDER_0## • Continuous Veno-Venous Hemofiltration ##PLACEHOLDER_0## • Continuous Veno-Venous HemoDialysis ##PLACEHOLDER_0## • Continuous Veno-Venous HemoDiaFiltration ##PLACEHOLDER_0## 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 ##PLACEHOLDER_0##, to perform fluid management and removal of uremic toxins. The removal of inflammatory mediators and endotoxins is performed simultaneously when indicated for CRRT.