Baxter International Inc. (NYSE:BAX) today announced the presentation of clinical data supporting the safety and efficacy of the VIVIA haemodialysis (HD) system. Results from two studies conducted in a clinical setting showed acceptable clearance of uremic toxins and an overall safety profile similar to that associated with conventional HD devices. The VIVIA system, designed to deliver High Dose HD in the home, completed the CE marking process (market approval) in Europe, December 2013.
These data for the VIVIA HD system were shared for the first time with the European nephrology community at the 51 st Congress of the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA), May 31 to June 3 in Amsterdam.
''We conducted the studies to evaluate the efficacy and safety of the VIVIA HD system, which demonstrated its ability to provide acceptable clearance of uremic toxins, safely and reliably,'' said Bruce Culleton, M.D., vice president, renal therapeutic area lead, Baxter. ''This research, in combination with the VIVIA HD system’s patient-friendly design features, may allow a greater number of dialysis patients suited for home HD to access High Dose HD therapy in the home environment.''
VIVIA Clinical StudiesThe first in-human study was a prospective, single arm clinical study (Abstract #SP415) conducted in haemodialysis centres in the United States, in which 22 patients received four HD treatments with the VIVIA HD system every week for 10 weeks. The mean duration of each HD treatment was 3.8 hours. A mean weekly standard measure of urea clearance (Kt/V urea) and dialysis adequacy, was 2.97. No device-related serious adverse events occurred during the study. The feasibility of multiple use of the same dialyser on the same patient was also established. In a second prospective, single arm clinical study (Abstract #SP431) conducted in haemodialysis centres in Canada, 17 patients received nocturnal HD treatments with the VIVIA HD system three times per week, for six weeks. The mean duration of nocturnal HD treatment was 7.0 hours. The feasibility of multiple use of the same dialyser on the same patient during long HD treatments was also established. No device-related serious adverse events occurred during the study. Both studies provided support of the VIVIA HD system’s capability to accurately remove excess body fluid, as shown by the strong correlation between fluid weight removed, as measured by the VIVIA HD system, and weight change (R 2 0.97 in both studies). A More Sustainable Therapy Additional data presented at the congress support non-clinical advantages for High Dose HD performed in the home, including a study demonstrating the VIVIA HD system had a smaller carbon footprint compared to a currently-available home HD device and to a conventional in-centre HD device that can be used for home dialysis (Abstract #SP440). The study used the life cycle assessment method to calculate emissions including consumable supplies, energy and water used during treatment, people transportation and waste disposal. Due in part to multiple uses of its dialyser and blood set, the VIVIA HD system generated the lowest amount of carbon emissions. These results suggest optimizing the use of consumables will have a significant impact in delivering sustainable HD therapies.
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