Baxter International Inc. announced Dec. 20 that it has completed CE requirements in Europe for its new VIVIA hemodialysis system. The portable machine is designed to deliver more frequent, extended duration, short daily or nocturnal (high dose) home hemodialysis therapy.
“Globally, less than 1% of the estimated 1.9 million patients requiring hemodialysis currently perform high dose HD therapy,” said Bruce Culleton, MD, senior medical director at Baxter. “VIVIA will allow a greater number of hemodialysis patients access to high dose HD therapy in their home environment.”
Baxter says the VIVIA system is designed to be patient friendly; a touch screen and graphic user interface displays large, easy-to-comprehend graphics and animations that help guide patients through setup, treatment and cleanup, the company said. 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 an interface between patients and their health care practitioners, VIVIA includes the Sharesource wireless connectivity platform that allows physicians and nurses to comprehensively monitor home dialysis therapy remotely.
The company said it will introduce VIVIA in a limited number of European dialysis clinics in 2014 to allow patients and health care providers to become familiar with the system and its features. Baxter said it 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.