Baxter obtains CE Mark approval for Vivia haemodialysis system

23 December 2013 (Last Updated December 23rd, 2013 06:30)

Baxter International has gained CE mark approval for its Vivia haemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home high dose (HD) therapy.

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Baxter International has gained CE mark approval for its Vivia haemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home high dose (HD) therapy.

Vivia is designed to be more patient-friendly, using easy-to-read graphics and animation to help guide patients through setup, their dialysis treatment and cleanup.

With its access disconnect sensor, the device stops pumping if the needle dislodges. The system also has one-button fluid infusion to help minimise user error and promote additional safety for the patient.

The system also uses wireless communication to connect patients with clinicians via the Sharesource platform, allowing physicians and nurses to remotely monitor home therapy.

Baxter senior medical director Dr Bruce Culleton said globally, fewer than 1% of the estimated 1.9 million patients requiring haemodialysis currently perform HD therapy.

''Vivia will allow a greater number of hemodialysis patients access to high dose HD therapy in their home environment,'' Dr Culleton said.

While Baxter will introduce Vivia in a limited number of European dialysis clinics in 2014, it intends to expand its commercial launch in other European countries in 2015.

According to the company, data from clinical trials conducted in the US 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.

Baxter Renal business president Brik Eyre said the company is committed to providing physicians and its patients with product and therapy options for the best clinical outcomes possible.

''The Vivia system was developed to support renal patients' unmet need for an innovative home-based hemodialysis option,'' Eyre said.


Image: Home hemodialysis device designed to deliver more frequent or extended duration dialysis. Photo: courtesy of Business Wire/ Baxter International Inc.