Baxter’s VIVIA hemodialysis system receives CE marking in Europe

Baxter International Inc. (NYSE:BAX) today announced completion of CE marking in Europe for the VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapy.

''Globally, less than 1 percent of the estimated 1.9 million patients requiring hemodialysis currently perform High Dose HD therapy,'' said Bruce Culleton, M.D., senior medical director, Baxter. ''VIVIA will allow a greater number of hemodialysis patients access to High Dose HD therapy in their home environment.''

VIVIA is designed with the patient as the primary operator. Its touch screen and graphic user interface displays large, easy-to-comprehend graphics and animations that help guide patients through setup, treatment and cleanup. VIVIA's Access Disconnect Sensor causes the system to stop pumping if the needle dislodges. The system also has one-button fluid infusion to help minimize user error and promote additional safety for the patient. To support the important interface between patients and their healthcare practitioners, VIVIA includes the fully integrated Sharesource wireless connectivity platform that allows physicians and nurses to comprehensively monitor home therapy remotely.

Baxter will introduce VIVIA in a limited number of European dialysis clinics in 2014 to allow patients and healthcare providers to become familiar with the system and its patient-friendly features. Baxter plans to expand the launch to other European countries in 2015.

Data from clinical trials conducted in the United States and Canada evaluating the safety and effectiveness of VIVIA in more than 1,000 treatments were submitted as part of the filing for CE marking. CE mark is a regulatory requirement for medical devices to be sold in the European Union.

''At Baxter, we are committed to providing physicians and their patients with product and therapy options for the best clinical outcomes possible,'' said Brik Eyre, president of Baxter's Renal business. ''The VIVIA system was developed to support renal patients' unmet need for an innovative home-based hemodialysis option.''

Rx only. For safe and proper use of this device, refer to the complete instructions in the operator's manual.

High Dose HD

An estimated 1.9 million end-stage kidney disease (ESKD) patients worldwide undergo hemodialysis, with the vast majority receiving conventional hemodialysis (CHD), which is usually performed three times a week for three to five hours per session in a center or clinic.

High Dose HD therapy is a more frequent therapy usually performed as short daily treatments at least five days per week for sessions that typically run less than four hours, or as nocturnal treatments where sessions are conducted for greater than six hours while the patient sleeps. High Dose HD therapy is associated with improvements in survival and clinically important health measures, including health-related quality of life, compared with CHD.

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