Baxter has presented results from two clinical studies evaluating the safety and efficacy of the VIVIA haemodialysis (HD) system at the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA) congress in Amsterdam, the Netherlands.
Data from the two clinical studies, conducted in the US and Canada, demonstrated acceptable clearance of uremic toxins and an overall safety profile similar to that associated with conventional HD devices.
Baxter vice president and renal therapeutic area lead Bruce Culleton said: "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."
The US study is a first in-human study in which 22 patients received four HD treatments with the VIVIA HD system every week for ten weeks. In this prospective, single arm clinical study, feasibility of multiple use of the same dialyser on the same patient was also established.
In the Canadian study, 17 patients received nocturnal HD treatments with the VIVIA HD system three times per week for six weeks. In this prospective, single arm clinical study, feasibility of multiple use of the same dialyser on the same patient during long HD treatments was also established.
The two clinical 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.
Baxter has designed the VIVIA HD system to deliver high dose haemodialysis in the home. The device received CE Mark approval in December 2013.
The company will initially launch the VIVIA HD system on a limited basis in 2014 in select European dialysis clinics.
Image: The VIVIA haemodialysis system delivers high dose HD therapy in the home. Photo: Courtesy of Baxter International Inc.