Safety and Performance Evidence

HDx therapy delivers meaningful and relevant innovation for dialysis patients.

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Safety and Performance Evidence

When creating internal filtration through HDx and MCO, the permeability of the MCO Theranova membrane for endotoxins is not significantly different vs low-flux, high-flux, and high cut-off membranes.9

Importance of Safety and Performance

Reduced levels of uremic solutes might indicate a reduced degree of uremic toxicity. Evaluation can be made in vivo and/or in vitro and is assessed over the course of a single treatment.

HDx Therapy Enabled by theranova

Primary clinical studies illuminate the benefits of HDx therapy enabled by Theranova

Weiner DE et al. Efficacy and safety of expanded hemodialysis with the Theranova 400 dialyzer: A randomized controlled trial.

Theranova provides significant and superior removal of conventional/large middle molecules compared to conventional hemodialysis while retaining stable albumin levels.3

Krishnasamy R et al. A trial evaluating mid out-off value membrane clearance of albumin and light chains in hemodialysis patients (REMOVAL-HD): a safety device study.

Theranova efficiently removes middle molecules up to 45 kDa, such as lambda-FLC, while maintaining stable serum albumin levels, with only 0.7g/L decline in overall serum concentrations.1

Bunch A et al. Medium cut-off dialyzers in a large population of hemodialysis patients in Colombia: COREXH Registry.

Theranova is safe and preserves serum albumin levels within the normal range among patients undergoing expanded hemodialysis (HDx).5

Kirsch AH, et al. Performance of hemodialysis with novel medium cut-off dialyzers.

Theranova provides efficient removal of large middle molecule uremic toxins compared to traditional high flux membranes used during high-flux hemodialysis and hemodiafiltration, with limited albumin between 1 and 4g per treatment.2

Belmouaz M et al. Comparison of Hemodialysis with Medium Cut-Off Dialyzer and On-Line Hemodiafiltration on the Removal of Small and Middle-Sized Molecules.

This study is the first evaluating efficacy and safety of MCO-HD with the new-generation Theranova-500 dialyzer in HD over a 6-month period, showing similar removal for small molecules, β-2 microglobulin and myoglobin when compared to ol-HDF, with good tolerance profile and without modification of nutritional status.6

Wolley M, Jardine M, Hutchison CA. Exploring the clinical relevance of providing increased removal of large middle molecules.

Theranova improves removal of middle-molecule uremic toxins that have been linked to the development of chronic inflammation, CVD, and other dialysis related comorbidities; this may result in improved patient outcomes.7

Ronco C and Clark WR. Hemodialysis membranes.

Theranova features an increased pore density with tight pore-size distribution, enhancing ultra-filtration and permeability via a steep

sieving-curve — resulting in clearance of larger uremic toxins, while retaining essential proteins.8

Boschetti-de-Fierro A et al. MCO membranes: enhanced selectivity in high-flux class.

Tailored pore sizes of the Theranova membranes promote removal of an expanded range of uremic toxins, while ensuring retention of albumin. MCO’s unique membrane design allows for a filtration profile that’s closer to the natural kidney.4

Schepers E et al. Assessment of the association between increasing membrane pore size and endotoxin permeability using a novel experimental dialysis set-up.

The present experiments demonstrate that, when using a 4-fold overload of endotoxin, the use of larger pore membranes, MCO and HCO, is likely safe from that regard. Indeed, in none of the experiments, biological activation of the inflammatory system was observed. The MCO (Theranova) membrane maintains the same endotoxin retention as other high-flux membranes.9

Provide Expanded Hemodialysis. Retain HD Simplicity.

Reference library

Hear from patients, nephrologists, and nurses alike share their experience prescribing HDx. Be reassured by the pioneering commitment of Baxter to dialysis patients the world over and learn how Theranova dialyzers are made.

HDx Compendium of Studies

On-going research and clinical reporting are an integral part of the HDx journey. Explore the expanding evidence related to HDx enabled by Theranova that nephrologists around the world continue to generate.

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HDx Therapy Brochure

Here you can find the HDx therapy brochure with more information about prescribing HDx for your hemodialysis patients.

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HDx Therapy Specification Sheets

Here you can find the detailed profiles of Theranova dialyzers.

Important Safety Information

Theranova dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
*Do not use Theranova dialyzers in HDF or HF mode.
For safe and proper use of this device, please refer to Instructions for Use.

CE 2797