The Vivia system is designed to provide shorter but more frequent dialysis rounds than conventional dialysis. The device has already won CE Mark approval in the European Union for use with Baxter’s Sharesource remote monitoring system, the company said.
Deerfield, Ill.-based Baxter said the 20-patient efficacystudy is designed to evaluate the Vivia system for frequent, extended nocturnal dialysis at home and in the clinic. The primary outcomes are change in Respiratory Disturbance Index, subjective sleep quality, Epworth sleepiness scale and sleep architecture at 6 months, according to ClinicalTrials.gov. The trial is slated to close in July 2018.
”Less than 2% of U.S. end-stage renal disease patients have access to home hemodialysis,” Baxter Renal president Jill Schaaf said in prepared remarks. ”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.”
Baxter said it’s expanded the limited European launch of the Vivia device this year. The Sharesource platform won clearance from the FDA last year along with the Amia peritoneal dialysis device.