Business Wire08.20.21
Baxter International Inc., a global innovator in renal care, announced new data showing expanded hemodialysis (HDx) therapy enabled by the Theranova dialyzer may reduce cardiovascular events by 35 percent and hospitalization rates by 18 percent, according to a new, large, multicenter, retrospective study of Colombian dialysis patients treated with long-term HDx compared to propensity-matched patients treated with High-Flux Hemodialysis.1
Theranova was designed to deliver HDx therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa),2,3,4 allowing for filtration closer to that of the natural kidney.5,6 These large middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.2,3,4
“Innovation is fueled by continued scientific study and exchange through meetings like the 58th ERA-EDTA,” said Peter Rutherford, M.D., senior medical director, Baxter Renal Care business. “These new findings support a growing library of evidence that kidney disease patients on HDx therapy enabled by Theranova may experience improved clinical outcomes and lower healthcare resource utilization.”
The new data are from an observational, multicenter, retrospective cohort analysis of more than 1,000 adult prevalent hemodialysis patients followed for up to two years at Baxter Renal Care Services clinics in Colombia. Weighted incidence rate ratios (IRRs) and rates and duration of hospitalization and cardiovascular events according to dialyzer type were obtained using binomial negative regression with the weighting sample. Hospitalization rates and hospitalization days were recorded over two years. While lower hospitalization rates and cardiovascular events were found in association with HDx therapy enabled by Theranova, no differences in hospitalization duration or survival were identified. Randomized clinical trials are needed to confirm the observed effect.
Theranova is currently used in more than 40 countries, including the United States where it was granted a De Novo application. By granting a De Novo, the U.S. Food and Drug Administration (FDA) established a new classification of dialyzer technology with unique performance standards. The U.S. FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space.
References
1 Molano A. et al. “Effectiveness of medium cut-off Vs high flux dialyzers: An inverse probability weighting cohort study” Abstract presented at the 58 ERA-EDTA Congress. 2021. [MO880]
2 Hutchison CA, et al. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol. 2017; 191:142-52.
3 Neirynck N, et al. An update on uremic toxins. Int Urol Nephrol. 2013; 45:139-50.
4 Duranton F, et al. European Uremic Toxin Work Group. Normal and pathologic concentrations of uremic toxins. J Am Soc Nephrol. 2012 Jul; 23(7):1258-70.
5 Zweigart C, et al. Medium cut-off membranes – closer to the natural kidney removal function. Int J Artif Organs. 2017; 40(7):328-334
6 Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports 2015; 5:18448.
Theranova was designed to deliver HDx therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa),2,3,4 allowing for filtration closer to that of the natural kidney.5,6 These large middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.2,3,4
“Innovation is fueled by continued scientific study and exchange through meetings like the 58th ERA-EDTA,” said Peter Rutherford, M.D., senior medical director, Baxter Renal Care business. “These new findings support a growing library of evidence that kidney disease patients on HDx therapy enabled by Theranova may experience improved clinical outcomes and lower healthcare resource utilization.”
The new data are from an observational, multicenter, retrospective cohort analysis of more than 1,000 adult prevalent hemodialysis patients followed for up to two years at Baxter Renal Care Services clinics in Colombia. Weighted incidence rate ratios (IRRs) and rates and duration of hospitalization and cardiovascular events according to dialyzer type were obtained using binomial negative regression with the weighting sample. Hospitalization rates and hospitalization days were recorded over two years. While lower hospitalization rates and cardiovascular events were found in association with HDx therapy enabled by Theranova, no differences in hospitalization duration or survival were identified. Randomized clinical trials are needed to confirm the observed effect.
Theranova is currently used in more than 40 countries, including the United States where it was granted a De Novo application. By granting a De Novo, the U.S. Food and Drug Administration (FDA) established a new classification of dialyzer technology with unique performance standards. The U.S. FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space.
References
1 Molano A. et al. “Effectiveness of medium cut-off Vs high flux dialyzers: An inverse probability weighting cohort study” Abstract presented at the 58 ERA-EDTA Congress. 2021. [MO880]
2 Hutchison CA, et al. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol. 2017; 191:142-52.
3 Neirynck N, et al. An update on uremic toxins. Int Urol Nephrol. 2013; 45:139-50.
4 Duranton F, et al. European Uremic Toxin Work Group. Normal and pathologic concentrations of uremic toxins. J Am Soc Nephrol. 2012 Jul; 23(7):1258-70.
5 Zweigart C, et al. Medium cut-off membranes – closer to the natural kidney removal function. Int J Artif Organs. 2017; 40(7):328-334
6 Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports 2015; 5:18448.