Baxter’s Hemodialysis System Wins European Approval

European regulators have greenlighted Baxter International’s VIVA hemodialysis system for the EU market. The device is designed for more comprehensive high dose hemodialysis (HD), which can be performed during short daily sessions or at night while sleeping.

The VIVA’s touchscreen interface was developed for patient use, since the system is intended to stay in the patient’s home, and instructions on the screen include graphical illustrations on setup, treatment, and cleaning. To help guarantee safety, the VIVIA features a sensor that detects dislodged needles and sends a signal for the machine to stop pumping.

Additionally, as with many at-home medical devices coming to market, the VIVIA features wireless connectivity to share its hemodialysis regimen data with the patient’s physician.

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.

“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 at Baxter. “VIVIA will allow a greater number of hemodialysis patients access to high dose HD therapy in their home environment.”

As part of its filing for CE marking, Baxter submitted data from U.S. and Canadian clinical trials that evaluated the safety and efficacy of VIVA in more than 1,000 treatments.

An estimated 1.9 million end-stage kidney disease 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 more than six hours while the patient sleeps. Data has shown high dose HD therapy to improve survival and health-related quality of life compared with CHD.