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June 3, 2014
09:02 EDTBAXBaxter presents efficacy and safety data on VIVIA system at ERA-EDTA Congress
Baxter International announced the presentation of clinical data supporting the safety and efficacy of the VIVIA haemodialysis 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 in Europe, December 2013. The 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 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.
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