INTRODUCING HDx THERAPY ENABLED BY THE THERANOVA DIALYZER

HDF performance and beyond,
as simple as HD

hdx

The THERANOVA dialyzer, featuring an innovative membrane, effectively targets large middle molecules not efficiently removed by currently available dialysis treatments. It provides the opportunity for an expanded hemodialysis therapy, HDx, providing HDF performance and beyond in the removal of middle and larger middle molecules, using regular HD infrastructure.

Do not use THERANOVA dialyzers for HDF or HF due to higher permeability of larger molecular weight proteins such as albumin.

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
ACHIEVED THROUGH MEMBRANE INNOVATION

Designed to target middle molecules effectively
and with safety in mind

HDx therapy enabled by the THERANOVA dialyzer may provide benefits to patients through an effective reduction of middle molecules achieved through higher permeability and enhanced selectivity.2

HIGHER PERMEABILITY
With an increased nominal pore size along the membrane, the THERANOVA dialyzer has a significantly higher permeability for large middle molecules than conventional high-flux membranes.10,11

ENHANCED SELECTIVITY
The THERANOVA dialyzer membrane, combining a unique asymmetric 3-layer structure12,13 with an increased nominal pore size along the membrane’s inner layer, enables a stable separation profile and selectivity throughout the treatment.

A STEP CLOSER TO THE NATURAL KIDNEY
By expanding the range of solutes removed in dialysis, while retaining selectivity towards for albumin and other essential proteins, the THERANOVA dialyzer is coming a step closer to the natural kidney.10,11

Three distinct layers of design

SMOOTH SURFACE AND ASYMMETRIC DESIGN
The THERANOVA membrane features a smooth blood-contacting surface of its thin inner layer or skin. It is charaterized by hydrophobic/hydrophilic micro-domains, which may minimize interation with blood components, resulting in lower proteins adsorption and cells interation, which may help reduce risks of clotting.14

HDF PERFORMANCE AND BEYOUND AS SIMPLE AS HD

The premium performance and simplicity of the HDx therapy

THERANOVA is a dialyzer that can be used on any dialysis machine in standard HD mode, and perform an HDx therapy. This may achieve a similar solute removal compared to HDF. This removes the need for the more complex equipment required for convective therapies.

HDF PERFORMANCE AND BEYOND

  • Equivalent removal of small and conventional middle molecules
  • Greater removal possible for large middle molecules
  • Applicable to any patient requiring higher clearance of large uremic toxins

Do not use THERANOVA dialyzers for HDF or HF due to higher permeability of larger molecular weight proteins such as albumin.

AS SIMPLE AS HD

  • HD infrastructure: no need for HDF capaable monitors and specific water quality and fluid quality assurance measures15,16
  • Avoiding HDF additional running costs: no disposable infusion line, fewer ultrafilters, less dialysis water and less concentrates
  • Avoiding requirement for specialist training and extensive monitoring during therapy delivery17

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

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

  1. U.S. Renal Data System: USRDS 2015 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, MD; National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2015
  2. Tattersall JE, et al. Online Hemodiafiltration: Definition, Dose Quantification and Safety Revisited. Nephrology Dialysis Transplantation (2013); 10: 1093
  3. Chmielewski M et al. The peptidic middle molecules: is molecular weight doing the trick? Semin Nephrol. 2014;34:118-34
  4. Hörl W, et al. Hemodialysis Membranes: Interleukins, Biocompatibility, and Middle Molecules. J Am Soc Nephro (2012); 13 (Suppl.1): 562-571
  5. Hutchison CA et al. Quantitative assessment of serum and urinary polyclonal free light chains in patients with chronic kidney disease. Clin J Am Soc Nephrol. 2008;3:1684-90
  6. Deppisch RM et al. Complement components as uremic toxins and their potential role as mediators of microinflammation. Kidney Int Suppl. 2001 Feb;78:S271-7
  7. Duranton F et al. Normal and pathologic concentrations of uremic toxins. J Am Soc Nephrol. 2012 Jul;23(7):1258-70
  8. Sakurai K, et al. Biomarkers for evaluation of clinical outcomes of hemodiafiltration. Blood Purif (2013); 35 (Suppl.1): 64-8
  9. Okyay GU, et al. Novel inflammatory marker in dialysis patients: YKL-40. Ther Apher Dia (2013); 17: 193-201
  10. Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports (2015); 5: 18448
  11. Krause B, et al. Highly selective membranes for blood purification. Euromembrane Congress 2015, Abstract E139
  12. Krause B, et al. Polymeric Membranes for Medical Applications. Chemie Ingenieur Technik (2003); 75 (11): 1725-1732
  13. Nilsson LG, Beck W and Bosch J. Data on File. White Paper May 2013 (USMP/MG3/140052)
  14. Baxter. Data on file. Dialyzers Biocompatibility Report 2013
  15. Lebourg L, et al. Online hemodiafiltration: is it really more expensive? Néphrol Thérap (2013); http://dx.doi.org/10.1016/j.nephro.2013.03.010
  16. Mazairac A, et al. The cost–utility of hemodiafiltration versus hemodialysis in the Convective Transport Study. Nephrol Dial Transplant (2013); 28: 1865-1873
  17. Chapdelaine I, et al. Optimization of the convection volume in online post-dilution hemodiafiltration: practical and technical issues. Clin Kidney J (2015); 8: 191–198
See all references