Baxter International’s VIVIA system receives CE Mark

Baxter International has been granted CE Mark approval for the use of its VIVIA Hemodialysis System in Europe.

The device is designed to allow the dialysis patient to be the primary operator. As such, it features a touchscreen with a user interface that displays large, easy-to-comprehend graphics and animations which guide the user through the process.

Baxter will initially introduce the VIVIA system to a limited number of European dialysis clinics this year, allowing both patients and healthcare providers to become familiar with it before an expanded launch to other European countries next year.

Brik Eyre, president of Baxter's Renal business, said: "The VIVIA system was developed to support renal patients' unmet need for an innovative home-based hemodialysis option."

Data from clinical trials carried out in the US and Canada, which evaluated the safety and effectiveness of VIVIA across more than 1,000 treatments, was submitted as part of the process of filing for the CE Mark.