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.
More than Just Lines on a Map: Best Practices for U.S Bike Routes
Baxter wins European approval for new home hemodialysis machine
1. kidne y-pain.o rg
http://kidney-pain.o rg/baxter-wins-euro pean-appro val-fo r-new-ho me-hemo dialysis-machine/
Baxter wins European approval for new home hemodialysis
machine
Baxter International Inc. announced Dec. 20 that it has completed CE requirements in Europe f or its new
VIVIA hemodialysis system. T he portable machine is designed to deliver more f requent, 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 perf orm 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 f riendly; a touch screen and graphic user interf ace
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. T he system also has one-button f luid inf usion to help minimize user error
and promote additional saf ety f or the patient. To support an interf ace between patients and their health
care practitioners, VIVIA includes the Sharesource wireless connectivity platf orm that allows physicians and
nurses to comprehensively monitor home dialysis therapy remotely.
T he 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 f amiliar with the system and its f eatures. Baxter said it plans
to expand the launch to other European countries in 2015.
Data f rom clinical trials conducted in the United States and Canada evaluating the saf ety and ef f ectiveness
of VIVIA in more than 1,000 treatments were submitted as part of the f iling f or CE marking. CE mark is a
regulatory requirement f or medical devices to be sold in the European Union.
