US-based Baxter International has received CE Mark approval in Europe for its VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapy.
VIVIA HD system features a touch screen and graphic user interface, access disconnect sensor, one-button fluid infusion, and fully integrated Sharesource wireless connectivity platform.
According to Baxter, the systems’ touch screen and graphic user interface displays large, easy-to-comprehend graphics and animations that help guide patients through setup, treatment and cleanup.
The access disconnect sensor causes the system to stop pumping if the needle dislodges. The one-button fluid infusion helps minimize user error and promote additional safety for the patient.
The system’s wireless communication connects patients with clinicians via the Sharesource platform, allowing physicians and nurses to remotely monitor home therapy.
According to Baxter, the CE Mark approval is based on data from clinical trials conducted in the US and Canada evaluating the safety and effectiveness of VIVIA in more than 1,000 treatments.
Baxter Renal business president Brik Eyre said the company is committed to providing physicians and their patients with product and therapy options for the best clinical outcomes possible.
”The VIVIA system was developed to support renal patients’ unmet need for an innovative home-based hemodialysis option,” Eyre added.
In order to allow patients and healthcare providers to become familiar with the VIVIA system, the company will launch the system in a limited number of European dialysis clinics in 2014. The company is likely to expand the launch to other European countries in 2015.
Image: Baxter receives CE Mark approval for VIVIA hemodialysis system. Photo: Courtesy of Baxter International Inc.