Baxter Renal Care has pulled the plug on clinical trials in Canada and in the U.S. for its Vivia home hemodialysis machine.
Manufacturing of the machine will cease for the European market, where Baxter had begun a limited launch after gaining CE market approval in December 2013.
Baxter Renal, currently operating under interim president Giuseppe Accogli, announced June 7 that it was ending trials for the machine, citing “ongoing challenges with reliability” among other issues. “Baxter’s assessment about the likely rate of patient adoption in light of the complexity of the therapy, and in addition to ongoing challenges in product reliability and the resources necessary to attempt to address those challenges, have caused us to focus efforts on alternative home therapies,” the company said in a statement.
Baxter had given first glimpses of the Vivia to the U.S. renal community in February 2015 at the Annual Dialysis Conference, including a demonstration of how the machine works. This past March, the company announced that it had enrolled the first patient in a U.S. clinical trial for the home hemodialysis system. The trial was designed to test the machine for frequent, extended-duration nocturnal and short daily dialysis. Vivia showcased an integrated water purification module, safety sensors, and one-button fluid infusion. The investigational system also featured 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, president of Baxter Renal at the time of the announcement regarding the clinical trial. “This clinical trial is an important step in Baxter’s efforts to expand access to therapies for patients who require dialysis.”