FDAnews Device Daily Bulletin

Baxter Wins CE Mark Approval for VIVIA Hemodialysis System

Dec. 23, 2013

Baxter International will begin marketing its VIVIA hemodialysis system to dialysis clinics in a small number of European countries in 2014, following receipt of the CE mark, the company said Friday. Full distribution in other European countries is expected the following year.

The VIVIA system delivers extended duration, short daily or nocturnal high-dose dialysis therapy to patients who want to undergo dialysis at home, and includes a touchscreen with a user interface consisting of large-face, easy-to-read graphics and animations that lead patients through setup, treatment and cleanup.

To minimize patient errors, the system has a one-button fluid infusion and a safety mechanism that cuts off the device if its needle somehow becomes disconnected. The system also includes a Sharesource wireless platform that physicians and nurses can use to monitor patients remotely.

Less than 1 percent of an estimated 1.9 million dialysis patients around the world currently get high-dose hemodialysis therapy at home, according to Baxter. — Lena Freund