A healthcare professional holds a Theranova dialyzer by a AK 98 machine

A New Class of Dialyzer Membrane Technology

With the Theranova Dialyzer, Vantive has established a whole new class of dialyzer technology with the MCO membrane to provide expanded hemodialysis therapy — HDx.1

Hemodialysis one step closer to the natural kidney

HDx therapy uniquely enabled by the first-of-its-kind Theranova Dialyzer provides expanded hemodialysis therapy, thanks to the technology of its MCO membrane, bringing hemodialysis filtration one step closer to the natural kidney2 by removing large-middle molecule uremic toxins linked to cardiovascular disease, inflammation and other dialysis-related comorbidities.3

Female patient receiving HDx therapy in a hospital

Therapy with no special requirements

By simply changing the traditional (high-flux) dialyzer to the Theranova Dialyzer with the MCO membrane, diffusion and convection are conveniently combined inside the hollow fiber dialyzer to perform HDx therapy, with no special requirement of a particular hardware, preparation of replacement fluid, or additional nursing skill, beyond what is necessary to perform traditional hemodialysis in standard mode.4 

Medical professional providing HDx therapy to a woman in a hospital setting
An HD patient undergoing hemodialysis with the AK 98 dialysis system and Revaclear dialyzer

More about the Theranova Dialyzer

Discover more about how the Theranova Dialyzer works, the evidence that supports its use and available resources for additional information. 

Learn more

Renal care resources to support clinicians

We offer numerous resources that provide detailed information on using our AK 98 Dialysis System, which can deliver HDx therapy using the Theranova Dialyzer, and on our support services for both clinicians and patients.

View resources

Important Safety Information

INTENDED USE

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.

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INDICATIONS

The AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The AK 98 dialysis machine is not intended for Selfcare or Home use.

Rx Only. For safe and proper use of the products mentioned herein, please refer to the appropriate Operator’s Manual or Instructions for Use.

Vantive, AK 98, HDx, MCO and Theranova are trademarks of Vantive Health LLC or its affiliates.

References

  1. Device Classification Under Section 513(f)(2)(DeNovo). Accessdata.fda.gov. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN190042. Published 2020.

  2. 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.

  3. Ronco C, La Manna G. Expanded hemodialysis: a new therapy for a new class of membranes. Contrib Nephrol. 2017;190:124-133.

  4. Ronco C. The rise of expanded hemodialysis. Blood Purif. 2017;44(2):I-VIII.