Filtersets and Catheters for Individualised Acute Therapy

Oxiris

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 (in countries where PrisMax is cleared or registered).

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.

Indications

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.

Contraindications

It is contraindicated to use the oXiris set where patients present a known allergy to heparin or have type II thrombocytopenia caused by heparin (HIT Syndrome type II).

Any contraindications indicated in the respective Instructions for use of all drugs used simultaneously with this set should be taken into account.

For the following conditions a careful assessment of the individual risk/benefit ratio has to be made by the treating physician (relative contraindications):

• inability to establish vascular access,
• severe hemodynamic instability,
• known hypersensitivity to any component of the oXiris set.

GamCath

Indications

GamCath Dialysis Catheter Kits are used to obtain vascular access to perform extracorporeal blood purification. They can be used in the subclavian, jugular or femoral veins to treat patients with chronic or acute renal failure.

The GamCath Dialysis Catheter provides temporary vascular access to treat patients with chronic or acute renal failure that require extracorporeal blood purification.

Contraindications and exclusions

These catheters are not intended to be used as a treatment for existing infections.

These catheters are not intended for any use other than which is indicated.

Do not insert the catheter in thrombosed vessels.

Intended Patient Population(s)

Adult or pediatric patients except those with thrombosed vessels who are afflicted with acute or chronic renal failure and may require, at the discretion of a qualified physician, temporary vascular access for extracorporeal blood purification are suitable to be treated with GamCath Dialysis Catheter Kit.

TPE Sets:

The Prismaflex TPE1000/TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy (therapeutic plasma exchange).

The Prismaflex TPE1000/TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.

The use of the Prismaflex TPE1000 set should be restricted to patients with a body weight greater than 9kgs (20lbs).

The use of the Prismaflex TPE2000 set should be restricted to adults.

The size, weight, state of uremia, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment.

The device should be used only on the direction of a physician who has evaluated all of the pertinent features of this device in relation to the individual patient. Patients with bleeding tendencies must be closely supervised during the treatment.

Treatment should be discontinued if acute hemorrhage that can not be corrected (hematemesis, hemoptysis and melena) occurs during TPE.

All treatments administered via the Prismaflex set must be prescribed by a physician.

For safe and proper use of the devices, please refer to the Instructions for Use.

CE 0123

CE 2797

Vantive, AN69ST, GamCath, Oxiris, Prismaflex, Prismax and TrueVue are trademarks of Vantive Health LLC or its affiliates.