Baxter International Inc. announced enrollment of the first patient in a US clinical trial for VIVIA, an investigational home haemodialysis (HD) system being developed by Baxter and DEKA Research & Development Corporation.
The trial is designed to study more frequent, extended duration nocturnal home HD therapy (High Dose HD), which will be performed in dialysis facilities as well as the home setting. The study is assessing safety of the product and adequacy of dialysis.
The VIVIA investigational home haemodialysis system includes an integrated water purification module, safety sensors and one-button fluid infusion. The investigational system also features SHARESOURCE, Baxter's two-way connectivity platform that allows physicians and nurses to monitor patients' historical treatment results remotely. VIVIA is an investigational device limited by federal law to investigational use only in the United States.
An estimated 600,000 to 700,000 Americans have end-stage renal disease (ESRD). The majority of US dialysis patients receive conventional haemodialysis (CHD), which is usually performed three times a week in a center or clinic, for three to five hours per session. In 2013, only 1.8 per cent of US adult dialysis patients received haemodialysis at home.
