Novaflux
technology in reprocessing hemodialyzers represents a breakthrough in
delivering better dialysis treatment for ESRD patients. The Novaflux
patented process solves the fundamental limitations of current dialyzer
reprocessing methods. The fundamental revision of the “entire” process
including fluid dynamics, cleaning and reprocessing protocol, and chemistry
has been achieved. The fluid dynamics delivered by the Novaflux
process is effective in removing blood clots and proteins from the entire
dialyzer, and thus delivering a dialyzer with performance like new and
extending the number of reuses to up to 40 times. The Phase I results
funded by NIH have demonstrated the significant advantages of the Novaflux
process over current reprocessing methods for cleaning Fresenius polysulfone
dialyzers, specifically: maintaining high TCV, increasing the number of
reuses, maintaining ß2-microglobulin and dialyzer urea clearance
with overall lower cost. The NIH Phase II study builds on the success
of the Phase I results with the goal of conducting a wider study to validate
the Novaflux technology for reprocessing
the Fresenius Optiflux 200A and Gambro Polyflux R17 dialyzers. 
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The
Phase II study will focus on maintaining the clearances of small (urea,
creatinine, phosphate) and large (ß2-microglobulin) molecules.
The goal is to maintain the membrane solute permeability characteristics,
while not increasing the permeability to proteins, such as albumin.
The clearance of small molecules, such as urea and creatinine, is more
dependent on flow parameters (i.e. Qb, Qd) than on membrane permeability
or area (KoA). Therefore, it is more difficult to demonstrate the effect
of improved cleaning on small molecule clearance independent of better
preservation of the TCV. In contrast, large molecule clearance is highly
dependent on KoA, so that improved cleaning (large available area or
TCV – both surface and pores) clearly affects ß2-microglobulin
clearances. The validation requirements are: removing residual cleaning
agents; maintaining biocompatibility; dialyzer disinfection; and testing
the entire reprocessing system in a clinical setting.
A photograph of the prototype dialyzer reprocessing
device installed at a DCI clinic operated by Robert Wood Johnson Hospital
– UMDNJ. The reprocessing device is capable of measuring TCV, pressure
leak and performing the cleaning and disinfection of hemodialyzers.
This device will be used as a basis of the final prototype and for the
510(k) application to the FDA.
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Novaflux Technologies has been developing a complete hemodialyzer-reprocessing device on the basis of its patented methods and compositions. The device will be used in two clinical trials that will be concluded by the end of 2002. We plan to submit a 510(k) application immediately after completion of the clinical studies. |
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