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The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. The Theranova Dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient's blood volume.

The Theranova 400 and 500 Dialyzers (referred to collectively as Theranova Dialyzers) are hollow fibers dialyzers that are intended for use in the treatment of chronic renal failure by intermittent hemodialysis. The hollow fiber membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP). The membrane surface area for the Theranova 400 Dialyzer is 1.7 m2. while that for the Theranova 500 Dialyzer is 2.0 m². Theranova Dialyzers are intended to be used as part of a high permeability hemodialysis system (such as those regulated under 21 CFR §876.5860). Theranova Dialyzers should be used with blood tubing sets with connectors that comply with ISO 8637 and a monitor that controls and monitors the ultrafiltration rate. Theranova Dialyzers are not intended to be used for hemofiltration or hemodiafiltration. Thev are steam-sterilized, single use only devices. Theranova Dialyzers are intended to treat chronic renal failure by removal of solutes and plasma water from the blood when used with a hemodialysis monitor capable of ultrafiltration control. The blood travels through the hollow fibers and exits via a blood exit port. Plasma water and certain low and middle molecular weight solutes pass through the hollow fiber membrane and into the countercurrent flowing dialysis solution, removing uremic toxins and waste products by means of diffusion and convection. In addition to the typical removal of small solutes and plasma water, Theranova Dialyzers can remove greater amounts of larger solutes (up to 45 kDa) due to the membrane design.