|[December 20, 2013]
Baxter Completes CE Mark Approval for VIVIA Hemodialysis System in Europe
DEERFIELD, Ill. --(Business Wire)--
Baxter International Inc. (NYSE:BAX) today announced completion of CE
marking in Europe for the VIVIA hemodialysis (HD) system, designed to
deliver more frequent, extended duration, short daily or nocturnal home
HD therapy, known as High Dose HD therapy1.
Baxter's VIVIA hemodialysis (HD) system is designed to treat end stage renal disease patients by delivering more frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapy. The system's touch screen and graphic user interface displays large, easy-to-comprehend graphics and animations that help guide patients through setup, treatment and cleanup. Among its features is a fully integrated wireless connectivity platform that allows healthcare providers to monitor their patients remotely. (Photo: Business Wire)
''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, Baxter. ''VIVIA will
allow a greater number of hemodialysis patients access to High Dose HD
therapy in their home environment.''
VIVIA is designed with the patient as the primary operator. Its touch
screen and graphic user interface displays large, easy-to-comprehend
graphics and animations that help guide patients through setup,
treatment and cleanup2. VIVIA's Access Disconnect Sensor
causes the system to stop pumping if the needle dislodges1,2.
The system also has one-button fluid infusion to help minimize user
error and promote additional safety for the patient1. To
support the important interface between patients and their healthcare
practitioners, VIVIA includes the fully integrated Sharesource wireless
connectivity platform that allows physicians and nurses to
comprehensively monitor home therapy remotely1.
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 Euopean 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 marking1,3.
CE mark is a regulatory requirement for medical devices to be sold
in the European Union.
''At Baxter, we are committed to providing physicians and their patients
with product and therapy options for the best clinical outcomes
possible,'' said Brik Eyre, president of Baxter's Renal business. ''The
VIVIA system was developed to support renal patients' unmet need for an
innovative home-based hemodialysis option.''
Rx only. For safe and proper use of this device, refer to the
complete instructions in the operator's manual.
High Dose HD
An estimated 1.9 million end-stage kidney disease (ESKD) 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 clinic4.
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 greater than six hours while the patient
sleeps5. High Dose HD therapy is associated with improvements
in survival and clinically important health measures, including
health-related quality of life, compared with CHD6,7,8,9.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives of
people with hemophilia, immune disorders, infectious�diseases, kidney
disease, trauma and other chronic and acute medical conditions. As
a�global, diversified healthcare company, Baxter applies a unique
combination of expertise in medical devices, pharmaceuticals and
biotechnology to create products that advance patient care�worldwide.
This release includes forward-looking statements concerning VIVIA,
Baxter's home hemodialysis system, including expectations regarding the
planned launch of VIVIA in Europe and its potential impact on
patients.�The statements are based on assumptions about many important
factors, including the following, which could cause actual results to
differ materially from those in the forward-looking statements:�actions
of regulatory bodies and other governmental authorities; satisfaction of
regulatory and other requirements; product quality or patient safety
issues; changes in laws and regulations; and other risks identified in
Baxter's most recent filing on Form 10-K and other SEC (News - Alert) filings, all of
which are available on Baxter's website. Baxter does not undertake to
update its forward-looking statements.
1 Data on file, Baxter International Inc., Oct. 1, 2013
2 Data on file, Baxter International Inc., June 27, 2012
3 Data on file, Baxter International Inc., May 16, 2013
4 Fresenius Medical Care: ESRD Patients in 2011, A Global
Perspective. Available at http://www.vision-fmc.com/files/download/ESRD/ESRD_Patients_in_2011.pdf.
Accessed September 4, 2013.
5 Data on file, Baxter International Inc., November 8, 2013
6 Pauly RP, Gill JS, Rose CL, et al. Survival among nocturnal
home haemodialysis patients compared to kidney transplant recipients. Nephrol
Dial Transplant. 2009;24(9):2915-2919.
7 Chertow GM, Levin NW, Beck GJ; FHN Trial Group. In-center
hemodialysis six times per week versus three times per week. N Engl J
8 Nesrallah GE, Lindsay RM, Cuerden MS, et al. Intensive
hemodialysis associates with improved survival compared with
conventional hemodialysis. J AM Soc Neprol. In press.
9 Culleton B, et al. Effect of frequent nocturnal
hemodialysis vs conventional hemodialysis on left ventricular mass and
quality of life. JAMA 2007; 298 (11) 1291-1299.
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