Performance Evidence
HDx therapy enabled by Theranova dialyzer provides superior removal of large-middle molecules, particularly kFLC compared with HD and HDF modalities, and it can do so using regular HD workflow and infrastructure.1
Importance of performance
Reduced levels of uremic solutes might indicate a reduced degree of uremic toxicity. Removal of uremic solutes can be evaluated by changes in levels over the course of a single treatment.
Weiner DE, Falzon L, Skoufos L, et al. Efficacy and safety of expanded hemodialysis with the Theranova 400 dialyzer: a randomized controlled trial.
Theranova dialyzer provides significant and superior removal of conventional/large-middle molecules compared to conventional hemodialysis while retaining stable albumin levels.2
Krishnasamy R, Hawley CM, Jardine MJ, 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 dialyzer efficiently removes middle molecules up to 45 kDa, such as lambda-FLC, while maintaining stable serum albumin levels, with only 0.7 g/L decline in overall serum concentrations.3
Bunch A, Sanchez R, Nilsson LG, et al. Medium cut-off dialyzers in a large population of hemodialysis patients in Colombia: COREXH registry.
Theranova dialyzer is safe and preserves serum albumin levels within the normal range among patients undergoing HDx therapy.4
Kirsch AH, Lyko R, Nilsson LG, et al. Performance of hemodialysis with novel medium cut-off dialyzers.
Theranova dialyzer 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 4 g per treatment.1
Belmouaz M, Diolez J, Bauwens 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 the efficacy and safety of the MCO membrane 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.5
Hagemann F, Linkhorst J, Roth H, Wessling M. On the balance between albumin loss and removal of middle molecules in dialyzers.
Among four dialyzer membranes, Theranova dialyzer offers the best compromise between good clearance of middle molecules and low albumin loss.6
Ronco C, Clark WR. Hemodialysis membranes.
Theranova dialyzer 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.7
Boschetti-de-Fierro A, Voigt M, Storr M, Krause B. MCO membranes: enhanced selectivity in high-flux class.
Tailored pore sizes of Theranova dialyzer membranes promote removal of an expanded range of uremic toxins while ensuring retention of albumin. The unique design of the MCO membrane allows for a filtration profile that is closer to the natural kidney.8
Lorenzin A, Golino G, de Cal M, et al. Flow dynamic analysis by contrast-enhanced imaging techniques of medium cutoff membrane hemodialyzer.
This study demonstrates the basis for the use of MCO membrane in expanded hemodialysis maximizing the benefits of internal filtration while maintaining the simplicity and safety of high-flux dialysis configuration and blood flows in the range of 300 mL/min.9
Interested in finding out more?
Contact Vantive to learn more about HDx therapy enabled by Theranova dialyzer.
Important Safety Information
Indications for Use: THERANOVA dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis
Caution: Do not use THERANOVA dialyzers for HDF (hemodiafiltration) or HF (hemofiltration) due to higher permeability of larger molecular weight proteins such as albumin.
For safe and proper use of the device, please refer to the Instructions for Use.
Vantive, HDx, MCO and Theranova are trademarks of Vantive Health LLC or its affiliates
References
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Kirsch AH, Lyko R, Nilsson LG, et al. Performance of haemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transpl. 2017;32(1):165-172.
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Weiner DE, Falzon L, Skoufos L, et al. Efficacy and safety of expanded haemodialysis with the Theranova 400 dialyzer: a randomized controlled trial. Clin J Am Soc Nephrol. 2020;15(9):1310-1319.
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Krishnasamy R, Hawley CM, Jardine MJ, et al. A trial evaluating mid cut-off value membrane clearance of albumin and light chains in haemodialysis patients: a safety device study. Blood Purif. 2020;49(4):468-478.
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Bunch A, Sanchez R, Nilsson LG, et al. Medium cut-off dialyzers in a large population of haemodialysis patients in Colombia: COREXH registry. Ther Apher Dial. 2021;25(1):33-43.
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Belmouaz M, Diolez J, Bauwens M, et al. Comparison of haemodialysis with medium cut-off dialyzer and on-line hemodiafiltration on the removal of small and middle-sized molecules. Clin Nephrol. 2018;89(1):50-56.
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Hagemann F, Linkhorst J, Roth H, Wessling M. On the balance between albumin loss and removal of middle molecules in dialyzers. J Membr Sci. 2023;3(1);100044.
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Ronco C, Clark WR. Haemodialysis membranes. Nat Rev Nephrol. 2018;14:394-410.
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Boschetti-de-Fierro A, Voigt M, Storr M, Krause B. MCO membranes: enhanced selectivity in high-flux class. Nature/Sci Rep. 2015;5:18448.
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Lorenzin A, Golino G, de Cal M, et al. Flow dynamic analysis by contrast-enhanced imaging techniques of medium cutoff membrane hemodialyzer. Blood Purif. 2022;51(2):138–146.