HDx enabled by Theranova

Change One Thing. Change Everything.

Introducing Expanded Hemodialysis (HDx) enabled by Theranova.

De Novo Granted / NOW AVAILABLE

Expanded Hemodialysis (HDx) enabled by Theranova is the next evolution in hemodialysis that brings us a step closer to the natural kidney.

Conventional/large middle molecular (500-45,000 Da) uremic toxins have been linked to the development of inflammation, cardiovascular disease (CVD) and other dialysis related comorbidities^1-3

CVD is strongly associated with inflammation, atherosclerosis and calcification. ~ 50% of patients with kidney failure (KF) die from CVD ^4-6

Traditional high-flux membranes, have limited capability to remove conventional and large middle molecular uremic toxins (up to 45,000 Da)⁷

Theranova's unique membrane design delivers superior removal of conventional/large middle molecules (up to 45,000 Da),^1,8-10 compared to high-flux membranes, while selectively retaining essential proteins and maintaining stable albumin levels^8,11,1

Theranova Spec Sheet

HDx therapy showed a significant reduction in hospital days and in-center medication usage, in a retrospective analysis (n=81).¹³ A Randomized Control Trial (n=171) showed a significant reduction of 45% in all-cause hospitalizations.¹⁴Improvement in certain inflammatory markers were observed in select patients (n=41).¹⁵

HDx-Theranova Brochure

HDx therapy may improve patient reported kidney disease quality of life outcomes including symptom burden, restless leg syndrome (RLS) criteria uremic pruritus and dialysis recovery time. ^8,10,15,16

Theranova Compendium

Simply change the dialyzer membrane to expand clearance and change everything for your patients.

Brenda's Story

How one dialysis patient's experience with HDx therapy changed her life.

How HDx enabled by Theranova works

Watch the video for more information on Theranova's mechanism of action.

Theranova Brochure Theranova Instructions for Use

Introducing HDx Talks Education Series

Access our on-demand video library of short (5-15 minutes) modules delivered by experts on topics like:

Innovations like the Theranova membrane that bring us one step closer to the natural kidney^1,9,10

Pathological role that conventional/large middle molecular toxins (up to 45,000 Da) play in the development of uremic clinical syndrome

Evidence surrounding clinical effectiveness, safety and efficacy, patient-reported Quality of Life and health economic outcomes related to HDx therapy

Hear from leading experts in Renal Care and Dialysis

Claudio Ronco, MD

University of Padua, Italy

Chris McIntyre, MD

University of Western Ontario, Canada

Ha Tran, MD, NS, FAAP

Baxter International, Inc.

Mary Gellens, MD

Baxter International, Inc.

The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. The Theranova Dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient's blood volume.

For single use only.
Rx Only. For the safe and proper use of this device, refer to the Instructions for Use.

References

Zweigart C, Boschetti-de-Fierro A, Hulko M, et al. Medium cut-off membranes - closer to the natural kidney removal function. Int J Artif Organs. 2017; 40(7):328–334. doi:10.5301/ijao.500060.
Hutchison CA, Wolley M. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol. 2017;191:142–152. Doi:10.1159/000479262.
Wolley M, Jardin M, Hutchison CA, Clin J Am Soc Nephrol 2018;13:1-10
Foley RN et al. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis. 1998;32 (Suppl 3):112-9
Cobo G et al. C-reactive Protein: Repeated Measurements will Improve Dialysis Patient Care. Sem Dialysis 2016;29:7-14
Yeun JY, et al. C-Reactive Protein Predicts All-Cause and Cardiovascular Mortality. Am J Kidney Dis 2000;35:469-476.
Ronco C & La Manna G Contrib Nephrol, 2017:190:124-133)
Kirsch AH, et al. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transpl 2017; 32(1):165-72.
Boschetti-de-Fierro, A., Voigt, M., Storr, M. et al. MCO Membranes: Enhanced Selectivity in High-Flux Class. Sci Rep 5, 18448 (2015). https://doi.org/10.1038/ srep18448.
Lim JH, Park Y, Yook JM, et al. Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients. 2020; 10:7780.
Krishnasamy R et al. Trial evaluating mid cut-off value membrane clearance of albumin and light chains in hemodialysis patients (REMOVAL-HD): a safety and efficacy study. ASN 2018 Kidney Week Abstract TH-PO353.
Bunch A, et al. Long Term Effects of Expanded Hemodialysis (HDx) on Clinical and Laboratory Parameters in a Large Cohort of Dialysis Patients. ASN 2018 Kidney Week Abstract FR-PO766.
Ariza JG et al. Measuring the association of switching patients from hemodialysis to expanded hemodialysis, with hospitalizations, medication use, costs and patient utility. Virtual International ISPOR 2020. Poster PUK15.
Blackowicz M et al. Health Economic Evaluation of the Theranova 400 Dialyzer Among Hemodialysis Patients in the United States: Results form a Randomized-Controlled Trial. ASN 2020 Kidney Week abstract.
Cantaluppi V et al. Removal of large-middle molecules, inhibition of neutrophil activation and modulation of inflammation-related endothelial dysfunction during expanded hemodialysis (HDx). Nephrol Dial Transplant 2019. Abstract FO048.
Alarcon et al. Impact of medium cut-off dialyzers on patient-reported outcomes (PROs): COREXH Registry. Blood Purif. https://doi.org/10.1159/000508803.
Kharbanda K et al. A randomised study investigating the effect of medium cut-off haemodialysis on markers of vascular health compared with on-line haemodiafiltration (MoDal study). Manchester University NHS Foundation Trust. Poster clinicaltrials.gov (NCT03510520).

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