INTRODUCING HDx THERAPY ENABLED BY THE THERANOVA DIALYZER

HDF performance and beyond,
as simple as HD

hdx

Not only can HDx therapy provide HDF performance and beyond in the removal of conventional middle and large middle molecules, it does so using regular HD workflow and infrastructure.1 The HDx therapy is enabled by the THERANOVA* dialyzer featuring an innovative membrane that combines a higher permeability than regular high-flux dialyzers with effective selectivity for large proteins.2,3


* Do not use THERANOVA dialyzers in HDF or HF mode

There is unmet need in helping patients' long-term health1

Conventional dialysis therapies fail to address all uremic solutes

Current dialyzer design, limited by membrane permeability. does not provide long-lasting, effective reduction of middle molecules, even when their usage is enhanced with convective transport.2

Focus on large middle molecules

Considering the importance of dialytic removal of large middle molecules

Today, large middle molecules, larger in size than beta 2 microglobulin, are increasingly seen as important to consider when prescribing dialysis.3 Dialytic removal of such large middle molecules is called for and therefore strategies for their effective removal should be developed.4

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Shifting focus to larger middle molecules and greater
membrane permeability

Progressive loss of renal function leads to the accumulation in body fluids of several compounds that are in the size range of 15 to 55 kDa. These are larger middle molecules and are not removed effectively by current dialytic modalities unless the dialyzer membrane pore size is large enough.3

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  • Free immunoglobulin light chains (FLCs, 22.5 and 45 kDa): plasma levels of kappa and lambda FLCs progressively increase as renal function deteriorates5
  • Complement factor D (24 kDa): circulating rate-limiting enzyme in the alternative complement system6 that in advanced kidney disease shows approximately a 10-fold increase in plasma7
  • Alpha 1 microglobulin (33 kDa): commonly used marker for the removal by dialysis of large middle molecules8
  • YKL-40 (40 kDa): plasma level is approximately doubled in dialysis patients compared to healthy people and shows a positive correlation with the C-reactive protein level in plasma9
A STEP CLOSER TO THE NATURAL KIDNEY

Turning innovative design into a clinical solution

The THERANOVA dialyzer enables the HDx therapy by combining 4 therapeutic principles: permeability, selectivity, retention and internal filtration – into a single dialyzer design. Its innovative medium cut-off (MCO) membrane expands the range of solutes removed during regular dialysis, while retaining essential proteins at a safe and controlled level. This unique cut-off and retention onset profile allows for filtration close to that of the natural kidney.2,3

HIGHER PERMEABILITY
With an increased nominal pore size, the THERANOVA dialyzer has a significantly higher permeability for large middle molecules compared to regular high-flux membranes, before and after blood contact.

EFFECTIVE SELECTIVITY FOR LARGE PROTEINS
By combining a unique asymmetric 3-layer structure with a carefully controlled distribution of the pore size, the THERANOVA dialyzer enables a stable separation profile and selectivity throughout the treatment, keeping albumin removal at a controlled level.

A STEP CLOSER TO THE NATURAL KIDNEY
By expanding the range of solutes removed in dialysis, while retaining selectivity towards albumin and other essential proteins, the THERANOVA dialyzer is coming a step closer to the natural kidney.

Three distinct layers of design


The membrane structure is asymmetric and can be seen in cross section as three distinct layers:

Retention

The adsorption properties of the THERANOVA membrane maintain the same level of bacteria and endotoxin retention as other standard dialysis membranes.4 Despite its higher permeability, the THERANOVA membrane appears to be a safe and effective barrier to potential dialysis fluid contaminants. It is compatible with standard fluid quality (ISO 11663:2014) and does not require any additional fluid quality control measure.5

Internal Filtration

The inner diameter of the THERANOVA membrane has been carefully reduced in order to increase internal filtration along the membrane, conducive to an enhanced removal of large middle molecules.

HDF PERFORMANCE AND BEYOND*

  • Equivalent removal of small and conventional middle molecules.
  • Greater removal possible for large middle molecules.
  • Applicable to all HD patients.

* Do not use THERANOVA dialyzers in HDF or HF mode.

AS SIMPLE AS HD

  • HD infrastructure: no need for HDF capable monitors nor specific water quality and fluid quality assurance measures.6
  • Avoid HDF additional running costs: disposable infusion line, use of larger amounts of dialysis water and concentrates.7
  • Avoid requirement for specialist training and extensive monitoring during therapy delivery.8

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DOWNLOADS

Brochure HDx
therapy
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Data sheet THERANOVA
400 Dialyzer
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Data sheet THERANOVA
500 Dialyzer
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