Baxter International Inc. has enrolled the first patient in a U.S. clinical trial for VIVIA, an investigational home hemodialysis system the company is developing with DEKA Research & Development Corporation. The hemodialysis machine was approved for sale in Europe in 2013.
The trial is designed to study more frequent, extended duration nocturnal home hemodialysis 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. High Dose hemodialysis 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.
VIVIA 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.
“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.”