Baxter International announced enrollment of the first patient in a U.S. clinical trial for VIVIA, an investigational home hemodialysis (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 hemodialysis 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.1
”Less than two percent of U.S. end-stage renal disease patients have access to home hemodialysis,” said Jill Schaaf, CVP and President, Baxter Renal.
”This clinical trial is an important step in Baxter’s efforts to expand access to therapies for patients who require dialysis. Working alongside the renal community, Baxter will continue to build support for the acceleration of home dialysis programs including addressing reimbursement and low awareness of therapy options among patients and clinicians.”
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 U.S. dialysis patients receive conventional hemodialysis (CHD), which is usually performed three times a week in a center or clinic, for three to five hours per session.2 In 2013, only 1.8 percent of U.S. adult dialysis patients received hemodialysis at home.3
High Dose HD therapy is a more frequent therapy usually performed as short daily treatments at least five days per week for sessions that typically run less than four hours, or as nocturnal treatments where sessions are conducted for greater than six hours while the patient sleeps.4
High Dose HD therapy is associated with improvements in survival and clinically important health measures, including health-related quality of life, compared with CHD.
Baxter has completed the CE marking process (market approval) for the VIVIA HD system with SHARESOURCE connectivity platform in Europe, where it has been introduced in select dialysis clinics.
Baxter is expanding the launch throughout 2016. In 2015, Baxter’s SHARESOURCE connectivity platform was cleared by the Food and Drug Administration in the United States in conjunction with Baxter’s AMIA automated peritoneal dialysis system.