Baxter nails a CE mark for next-generation home hemodialysis

Baxter's Vivia hemodialysis system--Courtesy of Baxter

Baxter International ($BAX) made a splash in 2013 with its nearly $4 billion acquisition of Swedish dialysis competitor Gambro. It ends the year with a quieter accomplishment: a CE mark in Europe for a next-generation home dialysis device.

Baxter said it envisions a rollout of its Vivia hemodialysis system to a select number of European dialysis clinics starting in 2014, to help patients and providers get up to speed with the technology. A larger European launch will follow in 2015.

The Illinois device and pharmaceutical giant said that data involving more than 1,000 Vivia treatments from clinical trials in the U.S. and Canada helped support the CE marking. How does it compare to the competition? Vivia is meant to be more patient-friendly, using easy-to-read graphics and animation to help guide patients through setup, their dialysis treatment and cleanup. It auto-stops if the needle dislodges. Crucially, it provides high-dose hemodialysis therapy, an option that can be given more frequently, or for longer or shorter stretches, depending on the need, even when a patient is sleeping. Such an option is thought to help patients live longer and experience a better quality of life.

Vivia's conception as a home-use device is also a big game-changer, considering that hemodialysis is typically administered at a clinic or dialysis center a few days a week and can take several hours to complete.

Baxter is launching Vivia with its eyes on a large market: The company estimates that 1.9 million end-stage kidney disease patients around the world face hemodialysis. 

Having Vivia approved in Europe is the icing on the cake after a heady year. In September, Baxter closed its $3.9 billion acquisition of Gambro, gaining a significantly larger share of the global renal market in the process. EU regulators forced Baxter to sell off its continuous renal replacement therapy segment to ease antitrust concerns. Baxter must also get out of an outsourcing deal with Japan's Nipro by March 2016 to satisfy Chinese regulators.

- read the release

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